Improvements relating to respiratory support

Abstract

A method (and apparatus) of assessing a patient receiving respiratory support to determine a respiratory condition during a period is described, the method comprising: receiving, from one or more sensors, one or more patient parameters of the patient for a plurality of time points, the one or more patient parameters comprising at least one respiratory parameter; in a controller: determining, from the one or more patient parameters, a respiratory index for each time point, and determining a change in respiratory index over time; and determining, from the change in respiratory index over time, a respiratory condition of the patient.

Description

[0001] This application is a divisional application of the invention patent application filed on June 16, 2021, with application number 202180053505.2 (international application number PCT / IB2021 / 055293) and titled "Improvements Related to Respiratory Support". Technical Field

[0002] This disclosure relates to apparatus, systems and / or methods for using respiratory indices to determine aspects of breathing, including but not limited to changes in respiratory indices, respiratory status and / or respiratory support (e.g., based on respiratory indices and / or respiratory status). Background Technology

[0003] High-flow respiratory support has become popular and widely used. It has become a first-line treatment for patients with respiratory distress. High-flow respiratory support is also used to assist patients with impaired respiratory systems, including those with conditions such as COPD, pulmonary fibrosis, and asthma.

[0004] High-flow ventilator support can be used as an oxygenation tool for patients with respiratory distress or respiratory failure. Furthermore, because high flow prevents entrainment of room air, high-flow ventilator support can increase the amount of O2 delivered. However, a high O2 fraction (high FiO2) may potentially mask a patient's deterioration and delay escalation of care.

[0005] The patient may be upgraded to, for example, mechanical ventilation or non-invasive ventilation. The risks of invasive mechanical ventilation are well known, but delayed ventilation can also lead to prolonged hospital stays and increased mortality.

[0006] Therefore, it is desirable to determine when to escalate respiratory support. Further consideration may be given to assessing the patient's respiratory status so that clinicians can make better decisions regarding the patient's condition. Summary of the Invention

[0007] In one respect, this disclosure may be considered to include a method for assessing a patient receiving NHF respiratory support and, if necessary, modifying respiratory support based on that assessment, the method comprising: receiving one or more patient parameters from one or more sensors, the one or more patient parameters including at least oxygenation parameters; determining a respiratory index at multiple times in a controller; and determining, based on a trend of the respiratory index over time, whether a modification of respiratory support is required, and, if necessary, making the modification of respiratory support.

[0008] On the other hand, this disclosure may be considered to include a method of treating a patient with a respiratory support device, the method comprising receiving one or more patient parameters from one or more sensors, the one or more patient parameters including at least an oxygenation parameter, determining a respiratory index at multiple times in a controller, and determining whether a change in respiratory support is needed based on a trend of the respiratory index over time, and, if necessary, making the change in respiratory support.

[0009] Optionally, the respiratory index is the ROX index.

[0010] Optionally, the respiratory index can be determined based on one or more lung mechanics parameters and one or more oxygenation parameters.

[0011] Optionally, lung mechanics parameters are parameters that indicate lung mechanics, such as respiratory rate, expiratory time, and minute ventilation.

[0012] Alternatively, oxygenation parameters / oxygen exchange parameters are parameters that indicate oxygenation, such as SpO2, FiO2, FdO2, O2 fraction, etc. Although FiO2, FdO2, and O2 fraction are different, they can be approximate surrogate measures of each other and can be used interchangeably where appropriate.

[0013] Optionally, the evaluation phase may include one or more of the following:

[0014] • Assess respiratory status and determine whether it is normal, abnormal, worsening, stable, or improving.

[0015] • Assess whether changes in respiratory support are necessary (as a result of assessing respiratory status).

[0016] • If necessary, assess what changes in respiratory support are needed (e.g., escalation, de-escalation, increase or decrease of high-flow therapy, escalation to NIV or invasive ventilation, de-escalation from NIV or invasive ventilation, etc.).

[0017] Optionally, changes in the respiratory support phase may include:

[0018] • For example, indicating any of the above results during the evaluation phase through alerts, alarms, messages, or other indicators, and / or

[0019] • Make any changes identified during the evaluation phase.

[0020] Alternatively, the evaluation phase can be implemented by the following:

[0021] • Individual clinician

[0022] • No need for one or more assessment devices, treatment devices and / or other devices for clinicians.

[0023] • Or both a clinician and one or more devices.

[0024] Optionally, the respiratory support phase can be implemented by the following:

[0025] • Individual clinician

[0026] • No need for one or more assessment devices, treatment devices and / or other devices for clinicians.

[0027] • Or both a clinician and one or more devices.

[0028] On the other hand, this disclosure may be considered to include a method for assessing a patient receiving respiratory support during a certain period to determine respiratory status, the method comprising: receiving one or more patient parameters for multiple time points from one or more sensors, the one or more patient parameters including at least one respiratory parameter; and in a controller: determining a respiratory index and / or one or more component parameters for each time point based on the one or more patient parameters, and determining the change of the respiratory index and / or one or more component parameters over time, and determining the patient's respiratory status based on the change of the respiratory index and / or one or more component parameters over time.

[0029] Optionally, the patient is receiving respiratory support, and optionally, the respiratory support is high-flow respiratory support or non-invasive pressure respiratory support.

[0030] In one respect, this disclosure may be considered to include a method according to any of the preceding claims, wherein a clinician determines a patient’s respiratory status as “at risk but improving” when the ROX index is below a threshold, but the ROX index change indicator shows a trend toward reduced risk.

[0031] Optionally, if a clinician determines that a patient’s respiratory status is “at risk but improving,” the assessment device provides instructions, such as an initial alarm and display message indicating that the patient is at risk but improving.

[0032] Optionally, a clinician may classify a patient’s respiratory condition as “at risk and deteriorating” if the ROX index is below a threshold and the ROX index change indicator shows an upward trend in risk.

[0033] Optionally, if a clinician determines that a patient’s respiratory condition is “at risk and deteriorating,” the assessment device provides instructions, such as alarms and display messages indicating that the patient is at risk and deteriorating.

[0034] Optionally, clinicians may classify a patient's respiratory condition as "not at risk but deteriorating" in the following situations:

[0035] The ROX index is above the threshold, but the ROX index change indicator shows an upward trend in risk.

[0036] Optionally, if a clinician determines that a patient’s respiratory condition is “not at risk but is deteriorating,” the assessment device provides instructions, such as quietly issuing an alarm, and then loudly issuing an alarm if / when the ROX index drops below a threshold.

[0037] Optional:

[0038] Clinicians classify a patient's respiratory status as "stable" in the following situations:

[0039] The respiratory rate showed an upward trend (exceeding the threshold slope or other indicators of change), but SpO2 remained stable, and

[0040] A message is displayed on the screen.

[0041] Optional:

[0042] Clinicians will classify a patient's respiratory condition as "worsening" in the following situations:

[0043] The respiratory rate showed an upward trend (exceeding the threshold slope or other indicators of change) and SpO2 showed a downward trend.

[0044] The alarm has been activated.

[0045] Optionally, clinicians determine a patient’s respiratory status based on the ROX index compared to one or more thresholds.

[0046] Alternatively, clinicians may determine a patient’s respiratory status based on the following:

[0047] respiratory rate,

[0048] SpO2, and / or

[0049] FiO2

[0050] This determination is based on one or more thresholds.

[0051] Alternatively, clinicians may determine a patient’s respiratory status based on changes in the following over time:

[0052] Respiratory index, and / or

[0053] Patient parameters, such as respiratory rate, SpO2 and / or FiO2.

[0054] Optionally, clinicians determine a patient’s respiratory status based on changing indicators, such as the slope, magnitude, and / or angle of the respiratory index at multiple time points.

[0055] Optionally, clinicians determine a patient’s respiratory status based on changing indicators, such as the slope, magnitude, and / or angle between patient parameters (e.g., respiratory rate, SpO2, and / or FiO2) at multiple time points.

[0056] Optionally, clinicians determine a patient’s respiratory status based on the length of time required for a change in the respiratory index and / or the magnitude of the change within a threshold time.

[0057] Optionally, clinicians determine a patient’s respiratory status based on the time required for the respiratory index and / or change indicators to reach a threshold amount.

[0058] Optionally, the assessment device and / or respiratory support device may have a user interface, such as a display.

[0059] On the other hand, this disclosure may be considered to include a method for assessing a patient receiving respiratory support during a certain period to determine respiratory status, the method comprising: receiving one or more patient parameters for multiple time points from one or more sensors, the one or more patient parameters including at least one respiratory parameter; in a controller: determining a respiratory index for each time point based on the one or more patient parameters, and determining the change of the respiratory index over time; and determining the patient's respiratory status based on the change of the respiratory index over time.

[0060] Optionally, the patient is receiving respiratory support, and optionally, the respiratory support is:

[0061] High-flow respiratory support.

[0062] Optionally, during this period:

[0063] It is the treatment period.

[0064] A day or a part of a day

[0065] One night or part of one night,

[0066] During the Zi period,

[0067] A certain length of time.

[0068] Optionally, the one or more patient parameters are one or more lung mechanics parameters and one or more oxygenation parameters.

[0069] Optionally, lung mechanics parameters can be one or more of the following:

[0070] •Respiratory rate

[0071] •Exhalation time,

[0072] • Minute ventilation.

[0073] Alternatively, the oxygenation parameter can be one or more of the following:

[0074] •FiO2

[0075] •FdO2

[0076] •O2 score

[0077] •SpO2.

[0078] Optionally, the respiratory index is the ROX index.

[0079] Optionally, the ROX index is composed of: respiratory rate,

[0080] SpO2, and / or

[0081] FiO2, FdO2 and / or O2 fractions.

[0082] Optionally, the respiratory rate is determined by the controller based on one or more patient parameters received from one or more sensors.

[0083] Optionally, it may further include making changes to respiratory support based on respiratory status and / or respiratory index indications and / or making changes to respiratory support.

[0084] Optionally, the ROX index can be displayed in numerical and / or graphical form.

[0085] Optionally, determining the change in the respiratory index over time includes:

[0086] For multiple time points, determine the change of respiratory index over time at each of those time points.

[0087] Optionally, it further includes displaying the change of the respiratory index over time at each of the multiple time points.

[0088] Optionally, determining the patient's respiratory status based on the change of the respiratory index over time includes monitoring the change of the respiratory index over time at multiple time points.

[0089] Optionally, monitoring the change of the respiratory index over time at multiple time points includes: viewing the displayed change of the respiratory index over time at multiple time points, and / or calculating the change and comparing the change with relational information.

[0090] Optionally, it may further include displaying respiratory index thresholds and / or change index thresholds.

[0091] Optionally, determining the change of the respiratory index over time includes determining the trend of the respiratory index.

[0092] Optionally, the trend includes multiple instantaneous trends, and determining the trend includes determining multiple instantaneous trends over time.

[0093] Optionally, the trend or instantaneous trend is represented by a trend parameter that includes magnitude and direction, and optionally, it can be in the form of a vector or slope and magnitude.

[0094] Optionally, it further includes transmitting the determined changes in respiratory support to: clinicians, for example in the form of messages, alarms, respiratory status, respiratory index, and / or respiratory support devices.

[0095] Optionally, the one or more sensors include: one or more sensors arranged to sense the flow path of the respiratory support device, and / or one or more sensors arranged to sense parameters of the patient, and the controller receives the one or more patient parameters from the one or more sensors.

[0096] Optionally, it may further include displaying one or more of the following on the interface of the respiratory device, mobile device and / or other assessment device: the relationship between respiratory index and time, displayed graphically and / or numerically; the relationship between one or more components of the respiratory index (e.g., respiratory rate, SpO2, FiO2, etc.) individually, in combination and / or optionally with time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences and / or other indicators of change indicating the change between two or more respiratory indices and / or their components over time or other aspects.

[0097] Optionally, the method further includes receiving input (e.g., user input) for modifying the display and redisplaying information based on the user input. This receiving and redisplaying includes one or more of the following: receiving input for displaying one or more components of a respiratory index, and displaying the one or more components of the respiratory index graphically and / or numerically, individually, in combination, and / or optionally, in relation to time; and / or receiving input to display, zoom, and / or move the display, and displaying or redisplaying zoomed and / or moved versions of: the relationship between a respiratory index (e.g., the ROX index) and time, displayed graphically and / or numerically; one or more components of a respiratory index, individually, in combination, and / or optionally, in relation to time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change indicating the variation between two or more respiratory indices and / or their components over time or other aspects.

[0098] Optionally, clinicians determine a patient’s respiratory status by examining changes in respiratory indices over time by looking at: the relationship between respiratory indices (e.g., the ROX index) and time, displayed graphically and / or numerically; the relationship between one or more components of respiratory indices (e.g., respiratory rate, SpO2, FiO2, etc.), individually, in combination, and / or optionally, and time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change between two or more respiratory indices and / or their components over time or in other aspects.

[0099] Optionally, clinicians determine a patient’s respiratory status based on changes in the respiratory index over time by any one or a combination of the following: comparing one or more respiratory indices and / or changes in the respiratory index to one or more thresholds; comparing one or more change indicators to one or more thresholds; comparing one or more respiratory indices and / or changes in the respiratory index to one or more other respiratory indices and / or changes in the respiratory index and / or to one or more other change indicators; comparing one or more change indicators to one or more other change indicators and / or one or more respiratory indices and / or changes in the respiratory index; and considering one or more of the following: respiratory index, changes in the respiratory index over time, changes in the respiratory index over time, and / or change indicators.

[0100] Optionally, when determining a patient’s respiratory status, one or more of the following may occur to indicate the respiratory status: an alarm sounds, and / or a message is displayed that indicates the respiratory status, alerts the clinician and / or indicates the necessary action, and / or automatically and / or manually initiates a change in treatment.

[0101] In one respect, this disclosure may be considered to include an apparatus for assessing a patient receiving respiratory support during a period of time to determine respiratory status, the apparatus comprising: one or more sensors or inputs to one or more sensors for receiving one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; a controller for determining: a respiratory index for each time point based on the one or more patient parameters, and determining the patient's respiratory status based on changes in the respiratory index over time, and / or displaying changes in the respiratory index over time on a display for a user to determine the patient's respiratory status.

[0102] Optionally, the patient is receiving respiratory support, and optionally, the respiratory support is high-flow respiratory support.

[0103] Optionally: the assessment device provides respiratory support, or the assessment device is separate from the respiratory support device.

[0104] Optionally, during this period:

[0105] It is the treatment period.

[0106] A day or part of a day

[0107] One night or part of one night,

[0108] During the Zi period,

[0109] A certain length of time.

[0110] Optionally, the one or more patient parameters are one or more lung mechanics parameters and one or more oxygenation parameters.

[0111] Optionally, lung mechanics parameters can be one or more of the following:

[0112] •Respiratory rate

[0113] •Exhalation time,

[0114] • Minute ventilation.

[0115] Alternatively, the oxygenation parameter can be one or more of the following:

[0116] •FiO2

[0117] •FdO2

[0118] •O2 score

[0119] •SpO2.

[0120] Optionally, the respiratory index is the ROX index.

[0121] Optionally, the ROX index is composed of: respiratory rate,

[0122] SpO2, and / or

[0123] FiO2, FdO2 and / or O2 fractions.

[0124] Optionally, the respiratory rate is determined by the controller based on one or more patient parameters received from one or more sensors.

[0125] Optionally, the respiratory index is the ROX index determined based on respiratory rate, FiO2, and / or SpO2.

[0126] Optionally, the ROX index may be displayed on the display in a digital and / or graphical manner.

[0127] Optionally, determining the change in the respiratory index over time includes:

[0128] For multiple time points, determine the change of respiratory index over time at each of those time points.

[0129] Optionally, this includes displaying the change of the respiratory index over time at each of the multiple time points.

[0130] Optionally, determining the respiratory index based on its change over time includes the controller calculating the change and comparing it with relational information.

[0131] Optionally, the controller display may further be included:

[0132] Respiratory index threshold and / or change index threshold.

[0133] Optionally, it further includes transmitting the determined changes in respiratory support to: clinicians, for example in the form of messages, alarms, respiratory status, respiratory index, and / or respiratory support devices.

[0134] Optionally, the one or more sensors include: one or more sensors arranged to sense the flow path of the respiratory support device, and / or one or more sensors arranged to sense parameters of the patient, and the controller receives the one or more patient parameters from the one or more sensors.

[0135] Optionally, the device may be alone or integrated with one or more of the following:

[0136] Breathing equipment

[0137] mobile device,

[0138] server.

[0139] Optionally, a sensor may be included.

[0140] On the other hand, this disclosure may be considered to include a system for assessing a patient receiving respiratory support during a certain period to determine their respiratory status, the system comprising:

[0141] An apparatus described in any of the statements herein that performs the methods described in accordance with any of the statements herein.

[0142] Optionally, the device is configured to determine the patient's respiratory status by monitoring the changes in the respiratory index over time at multiple time points.

[0143] Optionally, at least one patient parameter is the patient's FiO2.

[0144] Optionally, the respiratory parameters are:

[0145] respiratory rate, and / or

[0146] SpO2.

[0147] Optionally, the device is configured to determine the change of the respiratory index over time, including determining the trend of the respiratory index.

[0148] Optionally, the trend includes multiple instantaneous trends, and determining the trend includes determining multiple instantaneous trends over time.

[0149] Alternatively, the change indicators may take the following forms:

[0150] Vector, or

[0151] Slope and magnitude.

[0152] Optionally, the device is further configured to display one or more of the following on an interface on a breathing device, mobile device, and / or other assessment device: the relationship between respiratory index and time, displayed graphically and / or numerically; the relationship between one or more components of the respiratory index (e.g., respiratory rate, SpO2, FiO2, etc.) individually, in combination, and / or optionally, and time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change indicating the variation between two or more respiratory indices and / or their components over time or other aspects.

[0153] Optionally, the device is further configured to receive input (e.g., user input) for modifying the display and to redisplay information based on the user input, wherein receiving and redistributing the input includes one or more of the following:

[0154] Receives input for displaying one or more components of the respiratory index, and displays the one or more components of the respiratory index graphically and / or numerically, individually, in combination, and / or optionally, in relation to time, and / or

[0155] Receive input for displaying, scaling, and / or moving the display, and display or re-display scaled and / or moved versions of the following:

[0156] The relationship between respiratory indices (e.g., ROX index) and time, displayed graphically and / or numerically.

[0157] One or more components of the respiratory index, individually, in combination, and / or optionally, in relation to time, are displayed graphically and / or numerically, and / or

[0158] One or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change that indicate the variation between two or more respiratory indices and / or their components over time or in other aspects.

[0159] Optionally, the device is further configured to allow clinicians to determine a patient's respiratory status by examining changes in the respiratory index over time by looking at the following:

[0160] The relationship between respiratory indices (e.g., ROX index) and time, displayed graphically and / or numerically.

[0161] One or more components of the respiratory index (e.g., respiratory rate, SpO2, FiO2, etc.), individually, in combination, and / or optionally, their relationship with time, are displayed graphically and / or numerically, and / or

[0162] One or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change that indicate the variation between two or more respiratory indices and / or their components over time or in other aspects.

[0163] Optionally, the device is further configured to allow clinicians to determine a patient's respiratory status based on changes in the respiratory index over time using any one or a combination of the following:

[0164] Compare one or more respiratory indices and / or changes in respiratory indices to one or more thresholds.

[0165] Compare one or more change indicators with one or more thresholds.

[0166] Compare changes in one or more respiratory indices and / or respiratory indexes with changes in one or more other respiratory indices and / or with one or more other change indicators.

[0167] Compare one or more change indicators with one or more other change indicators and / or one or more respiratory indices and / or changes in respiratory indices.

[0168] Consider one or more of the following:

[0169] Respiratory index,

[0170] Changes in respiratory index over time

[0171] Changes in respiratory index over time, and / or

[0172] Change indicators.

[0173] Optionally, the device is further configured to provide one or more of the following, which can occur to indicate the respiratory status, when determining the patient's respiratory status:

[0174] An alarm sounds, and / or a message is displayed indicating the respiratory condition, alerting the clinician, and / or instructing on necessary actions, and / or

[0175] Automatic and / or manual initiation of therapy changes.

[0176] Optionally, in the method or apparatus described, the respiratory index is the ROX index.

[0177] Optionally, in the method or apparatus described, the respiratory index is composed of respiratory rate, SpO2 and / or FiO2.

[0178] In another respect, this disclosure may be considered to include a method for assessing a patient receiving respiratory support during a certain period to determine respiratory status, the method comprising: receiving one or more patient parameters for multiple time points from one or more sensors, the one or more patient parameters including at least one respiratory parameter; determining, in a controller, a respiratory index and / or one or more component parameters for each time point based on the one or more patient parameters and changes over time of a respiratory index and / or one or more component parameters; and determining the patient's respiratory status based on changes over time of the respiratory index and / or one or more component parameters.

[0179] On the other hand, this disclosure may be considered to include a method for assessing a patient to determine changes in respiratory support, the method comprising: receiving from the patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; determining a respiratory index for each time point based on the one or more patient parameters; and determining changes in the patient's respiratory status and / or respiratory support based on trends in the respiratory index.

[0180] On the other hand, this disclosure may be considered to include a method for assessing a patient to determine changes in respiratory support, the method comprising: receiving from the patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; determining a respiratory index for each time point based on the one or more patient parameters; determining a change in the respiratory index over time based on a change in the respiratory index; and determining changes in the patient's respiratory status and / or respiratory support.

[0181] Optionally, determining the change of the respiratory index over time includes determining the trend of the respiratory index.

[0182] Optionally, the trend includes multiple instantaneous trends, and determining the trend includes determining multiple instantaneous trends over time.

[0183] Optionally, the trend or instantaneous trend is represented by a trend parameter that includes both magnitude and direction, and optionally, it can take the following forms:

[0184] Vector, or

[0185] Slope (i.e., gradient) and magnitude.

[0186] Optionally, the method further includes transmitting the determined changes in respiratory support to:

[0187] Clinicians, for example, receive messages, alerts, respiratory status, respiratory indexes, and / or

[0188] Respiratory support device.

[0189] Optionally, the method further includes controlling the respiratory support device based on the determined changes in respiratory support.

[0190] Optionally, the method further includes determining the patient's condition and / or changes in the patient's condition based on the respiratory index, and optionally transmitting the patient's condition to the clinician, for example, in the form of a message, alarm, and / or status.

[0191] Optionally, changes in the respiratory index, based on trends in the respiratory index to determine changes in the patient's respiratory status and / or respiratory support, include one or more of the following:

[0192] • Respiratory index or changes in respiratory index

[0193] • Trend or multiple instantaneous trends

[0194] • Trend parameters or multiple trend parameters

[0195] • Changes in the patient's respiratory status or respiratory status

[0196] Compare with relational information,

[0197] Optionally, the relationship information includes:

[0198] At least one threshold, and / or

[0199] The time during which the threshold is met, exceeded, or not exceeded.

[0200] Optionally, the method further includes transmitting one or more of the following:

[0201] • Respiratory index or changes in respiratory index

[0202] • Trend or multiple instantaneous trends

[0203] • Trend parameters or multiple trend parameters

[0204] • Changes in the patient's respiratory status or respiratory status

[0205] • Relationship information.

[0206] Optionally, the respiratory index is the ROX index, and the trend parameter is a vector indicating changes in the ROX index, and the relationship information is a threshold indicating the risk of respiratory failure.

[0207] Optionally, changes in respiratory support may involve either escalating or downgrading the respiratory support.

[0208] Optionally, upgraded respiratory support includes:

[0209] • Provides a higher level of high-flow respiratory support. Optionally, this can be achieved by increasing or providing high-flow parameters such as flow rate, O2 concentration, humidity, flow oscillation, and / or other high-flow parameters.

[0210] • Transfer the patient to more invasive respiratory support, such as:

[0211] oNIV stress breathing support

[0212] mechanical ventilator support via intubation

[0213] Optionally, the upgrade includes:

[0214] Control devices to upgrade respiratory support, and / or

[0215] Optionally, communication with clinicians can be initiated via messages, status updates, or alerts to escalate or consider escalating respiratory support.

[0216] Optionally, changes in respiratory support improved the patient’s respiratory status and / or respiratory index.

[0217] On the other hand, this disclosure may be considered to include a method for assessing a patient to determine changes in respiratory support, the method comprising: receiving from the patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; determining a respiratory index for each time point based on the one or more patient parameters; determining at least one vector having a magnitude and direction indicating a change in the respiratory index over time; and determining changes in respiratory support based on the vector.

[0218] On the other hand, this disclosure may be considered to include an apparatus for determining changes in respiratory support, the apparatus comprising: a controller configured to: receive from a patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; determine a respiratory index for each time point based on the one or more patient parameters; determine a change in the respiratory index over time based on a change in the respiratory index; determine changes in the patient's respiratory status and / or respiratory support; and an I / O interface for transmitting one or more of the following: the respiratory index and / or changes in the respiratory index, the patient's respiratory status, and changes in respiratory support.

[0219] Alternatively, the device is a breathing device that includes a flow generator and a humidifier.

[0220] Alternatively, the flow generator and humidifier can be integrated into the housing.

[0221] Optionally, the device further includes or is configured to be coupled to one or more of the following:

[0222] A sensor used to determine the O2 concentration of a gas.

[0223] A sensor used to determine a patient's respiratory rate.

[0224] Optionally, the device further includes a wireless communication transceiver.

[0225] Optionally, the device is a mobile device with an I / O interface and receives patient parameters using one or more of the following:

[0226] Mobile Telecom

[0227] Bluetooth TM

[0228] NFC.

[0229] Optionally, the mobile device delivers to the breathing apparatus:

[0230] respiratory index and / or changes in respiratory index

[0231] Patient's respiratory status, and / or

[0232] Changes in respiratory support

[0233] To control the breathing device and / or to communicate on the breathing device's I / O interface.

[0234] In another respect, this disclosure may be considered to include a method for controlling a respiratory device, the method comprising: determining the change of respiratory index over time based on patient parameters, determining changes in the patient's respiratory status and / or respiratory support based on the change of respiratory index, and communicating to a clinician how to change the respiratory support, and / or controlling the respiratory support device to change the respiratory support.

[0235] Optionally, changes in respiratory support improved the patient’s respiratory status and / or respiratory index.

[0236] On the other hand, this disclosure may be considered to include a method for determining one or more trend parameters of a respiratory index, the method comprising: receiving one or more patient parameters from a patient for multiple time points, the one or more patient parameters including at least one respiratory parameter; determining a respiratory index for each time point based on the one or more patient parameters; and determining one or more trend parameters representing the change of the respiratory index over time.

[0237] Optionally, the trend parameter includes magnitude and direction, and optionally, it can take the following forms:

[0238] Vector, or

[0239] Slope (i.e., gradient) and magnitude.

[0240] On the other hand, this disclosure may be considered to include a system for determining changes in respiratory support, the system comprising: a mobile device having a controller, an I / O interface, and a wireless communication transceiver, and a respiratory device having a controller, a flow generator, and a humidifier, wherein one or both of these controllers are configured to perform some or all of the following: receiving from a patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter; determining a respiratory index for each time point based on the one or more patient parameters; determining a change in the respiratory index over time based on a change in the respiratory index; and determining changes in the patient's respiratory status and / or respiratory support.

[0241] On the other hand, this disclosure may be considered to include an apparatus for determining changes in respiratory support, the apparatus comprising: a mobile device having a controller, an I / O interface, and a wireless communication transceiver, the mobile device being configured to receive from a patient one or more patient parameters for multiple time points, the one or more patient parameters including at least one respiratory parameter, determine a respiratory index for each time point based on the one or more patient parameters, determine a change in the respiratory index over time based on changes in the respiratory index, transmit information on the I / O interface, and / or determine or recommend changes in the patient's respiratory status and / or respiratory support.

[0242] Optionally, the mobile device receives patient parameters via a wireless transceiver using one or more of the following:

[0243] Mobile Telecom

[0244] Bluetooth TM

[0245] NFC

[0246] WiFi.

[0247] Alternatively, the mobile device receives patient parameters via a WAN, LAN, or wireless network.

[0248] Optionally, the mobile device delivers to the breathing apparatus:

[0249] respiratory index and / or changes in respiratory index

[0250] Patient's respiratory status, and / or

[0251] Changes in respiratory support

[0252] To control the breathing device and / or to communicate on the breathing device's I / O interface.

[0253] Optionally, the mobile device and / or breathing device may transmit one or more of the following in the I / O interface in the form of graphics, messages, displays, information, and / or sound or other means:

[0254] • Respiratory index or changes in respiratory index

[0255] • Trend or multiple instantaneous trends

[0256] • Trend parameters or multiple trend parameters

[0257] • Changes in the patient's respiratory status or respiratory status

[0258] • Relationship information.

[0259] On the other hand, this disclosure may be considered to include a mobile device and / or a mobile device programmed to perform a method comprising:

[0260] The patient receives one or more patient parameters at multiple time points, including at least one respiratory parameter.

[0261] The respiratory index is determined for each time point based on one or more patient parameters.

[0262] Determine how the respiratory index changes over time.

[0263] Determined based on changes in the respiratory index

[0264] Patient's respiratory status, and / or

[0265] Changes in respiratory support.

[0266] On the other hand, this disclosure may be considered to include a method implemented by a mobile device and / or a mobile device programmed to perform a method, the method further comprising:

[0267] One or more of the following can be transmitted in the I / O interface via graphics, messages, displays, information, and / or sound or other means:

[0268] • Respiratory index or changes in respiratory index

[0269] • Trend or multiple instantaneous trends

[0270] • Trend parameters (e.g., vectors, including magnitude and / or direction) or multiple trend parameters

[0271] • Changes in the patient's respiratory status or respiratory status

[0272] • Relationship information.

[0273] Optionally, the system or method can be configured to determine the change in flow rate required to improve the respiratory index provided by the respiratory support device, and can be configured to present instructions on a mobile device to change the flow rate or another parameter of the respiratory support device, wherein the change in flow rate or another parameter is one or more of the following:

[0274] Increase flow rate to improve respiratory index

[0275] Flow rate is changed based on or relative to changes in the respiratory index.

[0276] Changes in flow rate based on or relative to changes in a trend or trend parameters

[0277] FiO2 changes relative to changes in respiratory rate or relative to changes in respiratory index.

[0278] When the flow rate is changed relative to an exponential change, the control valve is used to increase or maintain FiO2.

[0279] Optionally, a system or method wherein the respiratory index is a ROX index based on SpO2, FiO2, and respiratory rate, and optionally, the system includes or is configured to be connected to one or more sensors from which SpO2, FiO2, and / or respiratory rate can be determined, and optionally, the respiratory rate is calculated in a controller based on the frequency response of a respiratory rate sensor.

[0280] Optionally, the mobile device uses the NFC protocol to capture / receive respiratory rate and FiO2.

[0281] Optionally, it may further include one or more of the following:

[0282] Respiratory rate sensor

[0283] Oxygen concentration sensor

[0284] Flow sensor (optionally inline)

[0285] pressure sensor

[0286] Temperature sensor

[0287] Ultrasonic sensor.

[0288] Optionally, the controller receives signals from one or more sensors and / or manual inputs, and calculates respiratory rate and FiO2 based on the received signals.

[0289] Optionally, in the system or method according to any of the preceding claims, the controller is configured to, or the method includes, calculate a trend of the respiratory index over a set time period based on respiratory rate and FiO2 measurements taken over the set time period, and / or the controller is configured to increase the flow rate from the baseline flow rate when the trend (or change) of the respiratory index indicates a deterioration in respiratory status, and / or the controller is configured to reduce the flow rate to the baseline flow rate when the respiratory index indicates an improvement in respiratory status.

[0290] In another respect, this disclosure may be considered to include a method for providing respiratory support, the method comprising: determining a respiratory index of a patient’s breathing at one or more time points, determining the change of the respiratory index over time, determining the patient’s respiratory status and / or appropriate respiratory support based on the change of the respiratory index, and providing the determined respiratory support to the patient.

[0291] In one implementation, the embodiment includes a mobile device that receives information from wearable sensors. The information is used as described above, and this information is transmitted to a clinician and a respiratory support device, for example via wired or wired transmission (including NFC), to control the device. The mobile device can communicate with the respiratory support device using Bluetooth, infrared, or another suitable wireless communication protocol. The mobile device can receive information from the respiratory device and sensors within the respiratory device. The mobile device can automatically check (i.e., query) the respiratory device at fixed time intervals to receive data from the sensors on the respiratory support device. Alternatively, the respiratory support device can periodically transmit data to the mobile device. In one example, NFC communication is advantageous because the user of the mobile device (e.g., a clinician) can begin implementation when sensor data from the respiratory support device is received at the mobile device. The mobile device can use methods as described herein to determine the effectiveness of respiratory support.

[0292] In one aspect, this disclosure may include an apparatus for providing respiratory support, the apparatus comprising: a housing; a flow generator (e.g., a blower) within the housing; an auxiliary gas inlet; a valve in fluid communication with the auxiliary gas inlet and configured to control the amount of auxiliary gas introduced into the apparatus; an outlet located within or on the housing; a gas path extending from the gas inlet to the outlet through the housing, wherein the flow generator is configured to receive auxiliary gas from the auxiliary gas inlet and generate a gas flow through the gas path; a plurality of sensors; and a controller in electronic communication with one or more sensors and receiving signals from the sensors, wherein the sensors are non-invasive sensors; the controller is configured to: determine lung mechanics parameters and oxygenation parameters based on the sensor signals; determine a respiratory index based on the lung mechanics parameters and oxygenation parameters; determine the change of the respiratory index over time; and adjust respiratory support based on the change of the respiratory index over time.

[0293] The device may optionally include a humidifier. The humidifier is located downstream of the flow generator and is configured to humidify the gas flow.

[0294] Optionally, the change in the respiratory index includes the trend of change or the rate of change or the second derivative of the rate of change.

[0295] Optionally, the respiratory device may include a communication interface configured to transmit information to a mobile device (e.g., a smartphone or tablet) associated with a clinician or healthcare professional and / or to a remote patient monitoring system. The remote patient monitoring system may include one or more servers, a storage unit, a database, and other components that allow for the management of patient information, the generation of patient health reports, and the sending of alerts to patients and / or clinicians. Changes in respiratory indexes may be transmitted to the mobile device and / or the remote patient monitoring system.

[0296] Respiratory index measurements and changes in the respiratory index can be incorporated into a patient report, which includes measured patient parameters such as SpO2, flow rate, humidity setpoint, and usage time, as well as the respiratory index and changes in respiratory index measurements over time.

[0297] Changes in the respiratory index allow clinicians to assess the effectiveness of the current treatment being administered and also allow them to modify the treatment being provided. In one example, the operating parameters of the respiratory support device (such as prescription settings) can be updated remotely based on changes in the respiratory index.

[0298] On the other hand, this disclosure may be considered to include a monitoring system, which includes:

[0299] Respiratory support devices (such as high-flow respiratory support devices, for example, nasal high-flow respiratory support devices).

[0300] A remote monitoring device for clinicians to monitor patients supported by ventilators.

[0301] and one or more controllers of the breathing device, remote monitoring device and / or other devices in the system, the one or more controllers being configured to:

[0302] Receive one or more patient parameters from one or more sensors at multiple time points, including at least one respiratory parameter.

[0303] In one or more controllers,

[0304] The respiratory index for each time point is determined based on one or more patient parameters, and

[0305] Determine how the respiratory index changes over time.

[0306] and

[0307] Providing information (in numerical, graphical, or other forms) to a remote monitoring device, which is one or more of the following:

[0308] Respiratory index, and / or

[0309] Changes in respiratory index over time.

[0310] Alternatively, one or more of the following may also be provided:

[0311] -Patient's respiratory status,

[0312] Changes in respiratory status over time

[0313] - Relationship between patient parameters and time

[0314] -Relationship between changes in patient parameters and time

[0315] -Respiratory index threshold,

[0316] -Threshold for change indicators

[0317] - Recommendations for respiratory support.

[0318] References to the ranges of numbers disclosed herein (e.g., 1 to 10) are intended to include references to all rational numbers within this range (e.g., 1, 1.1, 2, 3, 3.9, 4, 5, 6, 6.5, 7, 8, 9, and 10), as well as any range of rational numbers within this range (e.g., 2 to 8, 1.5 to 5.5, and 3.1 to 4.7), and therefore, all subranges of the ranges explicitly disclosed herein are hereby explicitly disclosed. These are merely examples of what is specifically intended to be disclosed, and all possible combinations of values ​​between the enumerated minimum and maximum values ​​should be considered as expressly stated in a similar manner in this application.

[0319] The term "comprising" as used in this specification means "consisting of at least part of...". When interpreting each statement using the term "comprising" in this specification, features other than the one or those features following the term may also be present. Related terms such as "comprise" and "comprises" will be interpreted in the same manner. Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise," "comprising," etc., should be interpreted in an inclusive sense, not in an exclusive or exhaustive sense; that is, in the sense of "including but not limited to."

[0320] References to patent specifications, other external documents, or other sources of information in this specification are generally made to provide context for discussing the features of this disclosure. Unless otherwise expressly stated, references to these external documents should not be construed as an admission that such documents, or such sources of information, are prior art or part of common general knowledge in any jurisdiction.

[0321] This disclosure can also be broadly interpreted to include any parts, elements, and features individually or collectively mentioned or indicated in the specification of this application, as well as any or all combinations of two or more of said parts, elements, or features. Wherein, in the foregoing description, reference has been made to components in whole or having their known equivalents, and these wholes are incorporated herein as if described separately.

[0322] For those skilled in the art to which this disclosure pertains, numerous structural changes to this disclosure, as well as a variety of widely differing embodiments and applications, will be apparent to them without departing from the scope of this disclosure as defined in the appended claims. The disclosures and descriptions herein are purely illustrative and are not intended to be limiting in any sense. When reference is made herein to a specific whole having known equivalents in the art to which this disclosure pertains, those known equivalents are considered to be incorporated herein as if separately stated. This disclosure includes the foregoing and also contemplates various structures, of which only examples are given below. Attached Figure Description

[0323] The various embodiments will now be described with reference to the following figures, in which:

[0324] Figure 1 The flowcharts for the assessment phase and respiratory support phase used to determine a patient's respiratory support needs as described in this disclosure are shown.

[0325] Figure 2 A graph showing the relationship between the respiratory index and time is presented regarding thresholds related to the patient's respiratory status.

[0326] Figure 3 The system for implementing the assessment and respiratory support phases is shown.

[0327] Figure 4 A graph showing the relationship between the ROX index and time is presented regarding thresholds related to the patient's respiratory status.

[0328] Figure 5 The graph shows the relationship between respiratory rate and FiO2, as well as the vector change of the ROX index over time, regarding thresholds related to the patient's respiratory status.

[0329] Figure 6 A respiratory support device is shown.

[0330] Figure 7 The mobile device and screen shown are used to assess a patient’s breathing.

[0331] Figures 8 to 10 Use cases of the described methods and apparatus are shown.

[0332] Figures 11A to 11E The example use case is shown. Detailed Implementation

[0333] the term

[0334] The terms "respiratory assist device," "respiratory apparatus," "respiratory support device," and "breathing apparatus" can be used interchangeably to define the same device.

[0335] Respiratory index—such as an indicator of a patient's breathing and / or gas exchange. A respiratory index is a parameter that determines respiratory status and / or decisions regarding the respiratory support provided to a patient. For example, a respiratory index can indicate an increase in the severity of respiratory distress, allowing clinicians to escalate treatment to more severe measures (e.g., NIV or intubation). A respiratory index can be determined based on / is a function of one or more lung mechanics parameters (such as respiratory rate, expiratory time, minute ventilation), and one or more oxygenation parameters (such as SpO2, FiO2, FdO2, fractional O2, etc.).

[0336] In alternative features, the respiratory index can be considered as a unitless number characterized as one or more of the following functions f(x):

[0337] • Patient parameters, which may include:

[0338] o Physiological parameters (which may include respiratory parameters), and

[0339] o Treatment parameters (treatment provided to the patient);

[0340] as well as

[0341] • Breathing device parameters (which may include operating parameters).

[0342] Lung mechanics parameters—that is, parameters that indicate lung mechanics, such as respiratory rate, expiratory time, and minute ventilation.

[0343] Oxygenation parameters / oxygen exchange parameters are parameters that indicate oxygenation, such as SpO2, FiO2, FdO2, and O2 fraction. Although FiO2, FdO2, and O2 fraction are different, they can be approximate surrogate measures of each other and can be used interchangeably where appropriate.

[0344] O2 fraction – is the fraction of oxygen in an airflow.

[0345] FiO2 – the fraction of oxygen inhaled by the patient

[0346] FdO2 — the fraction of oxygen delivered to the patient

[0347] SpO2 is the patient's blood oxygen concentration.

[0348] Respiratory status—the current state of a patient's breathing. Status can indicate normal breathing or respiratory distress. It can be an indicator and / or outcome of respiration and gas exchange. Respiratory status is affected by lung mechanics (such as respiratory rate) and gas exchange (i.e., blood gas exchange—as indicated by FiO2 requirements). Respiratory status changes over time.

[0349] Respiratory status—an indicator of a patient's current and / or likely future respiratory status. It includes respiratory condition, as well as any past or future changes or trends in the patient's overall health status, indicating present and likely future well-being. This can be used to predict the likely course of the patient's health condition and to determine what actions (if any) need to be taken.

[0350] Respiratory distress—an abnormal breathing pattern in a patient. For example, respiratory distress may be hypoxic respiratory distress, acute respiratory distress syndrome, hypercapnia-related respiratory distress, dyspnea, or impaired respiratory function. Respiratory distress can be classified as mild to severe (e.g., respiratory failure). For example, respiratory distress may range from mild to severe and may present as one or more of the following:

[0351] The patient had difficulty breathing.

[0352] The patient's respiratory rate increased.

[0353] Breathing deterioration leads to respiratory failure.

[0354] The onset of respiratory failure,

[0355] The occurrence of respiratory failure,

[0356] Increased O2 demand, for example, by increasing FiO2 to maintain SpO2 levels.

[0357] The patient's blood gas levels were abnormal.

[0358] Difficulty breathing

[0359] Low SpO2,

[0360] High PaCO2,

[0361] There is a high probability of compensatory dysfunction.

[0362] The first symptom is respiratory distress. Respiratory failure may follow.

[0363] Respiratory failure occurs when a patient's lungs are unable to receive enough oxygen into their bloodstream, and may manifest as abnormal blood gas patterns and / or respiratory abnormalities. The severity of respiratory failure can be indicated by respiratory rate and blood oxygen levels. The more severe the patient's condition, the more O2 they require and / or the higher their respiratory rate. For example, respiratory failure can be manifested and / or indicated by a respiratory rate that exceeds the resting respiratory rate, such as twice the resting respiratory rate.

[0364] Risk of respiratory failure – an indicator of the risk of respiratory failure onset

[0365] A change indicator—indicates how the respiratory index (or other parameter) changes over time (or any other parameter changes). It can be a slope, vector, angle, magnitude, difference, etc.—whether numerical or graphical. Mentions of any particular change indicator (e.g., slope) are generally used only as examples, and it will be recognized that other change indicators can convey the same or similar information, and mentions of a particular change indicator can generally be considered interchangeable with another change indicator.

[0366] High-flow respiratory support—generally, this provides a high flow rate of gas to support a patient's breathing. This can be provided, for example, by a nasal cannula in nasal high-flow respiratory support (NHF), or by an endotracheal interface (e.g., a tracheostomy adapter) in tracheal high-flow respiratory support. The term "high-flow respiratory support" may be used to refer to one or more of the following terms and types of respiratory support as used by those skilled in the art, but is not limited thereto. Note that some of these terms are similar to those used for the same type of respiratory support:

[0367] High flow

[0368] High-flow oxygen

[0369] • High flow rate for humidification

[0370] High-flow nasal oxygen

[0371] • High-flow nasal cannula

[0372] •High flow trachea

[0373] High flow rate delivery

[0374] • High-flow treatment

[0375] • Humidified high-flow nasal cannula

[0376] High-flow respiratory support can be used for respiratory distress and respiratory failure.

[0377] Non-invasive (NIV) pressure respiratory support – This is ventilatory support for a patient. It controls ventilation by providing bilevel pressure therapy. This therapy is a non-invasive pressure therapy. For example, bilevel pressure therapy, in which a higher pressure is provided during inspiration and a lower pressure is provided during expiration. This allows at least control of tidal volume and PEEP. NIV is both ventilatory support and ventilatory control. NIV is administered through a sealed interface. The terms NIV, NIV pressure respiratory support, and bilevel pressure support are used interchangeably.

[0378] Invasive respiratory support – generally speaking, this is mechanical ventilation provided to intubated patients.

[0379] Basic respiratory support – This is the initial respiratory support provided by a clinician, usually via nasal high-flow respiratory support or tracheal high-flow respiratory support.

[0380] High flow rate—(e.g., in relation to high-flow respiratory support)—means, but is not limited to, any flow of gas at a rate higher than normal / normal flow rate (e.g., higher than the normal inspiratory flow rate for a healthy patient). It can be provided by an unsealed respiratory system, where significant leakage occurs at the entrance to the patient's airway due to an unsealed patient interface (e.g., a nasal cannula). Providing high flow rate is part of high-flow respiratory support as defined above (e.g., high-flow nasal or high-flow tracheal support). It also incorporates humidification to improve patient comfort, compliance, and safety. Alternatively or additionally, high flow rate can be higher than some other threshold flow rate relevant to the context; for example, a flow rate that provides a flow of gas to the patient at a rate that meets or exceeds inspiratory needs can be considered "high flow rate" because it is higher than the nominal flow rate that would otherwise be provided. Therefore, "high flow rate" is context-dependent, and its composition depends on many factors, such as the patient's health condition, the type of routine / therapy / support provided, the patient's nature (adult, child, adult, pediatric), etc. Those skilled in the art will understand the composition of "high flow rate" from the context. Its flow rate exceeds and is higher than the flow rate that could have been provided.

[0381] However, but not limited to, some indicators of high flow can be as follows.

[0382] • In some configurations, gas is delivered to the patient at a flow rate greater than or equal to about 5 or 10 liters per minute (5 or 10 LPM or L / min).

[0383] • In some configurations, gas is delivered to the patient at a flow rate of about 5 or 10 LPM to about 150 LPM, or about 15 LPM to about 95 LPM, or about 20 LPM to about 90 LPM, or about 25 LPM to about 85 LPM, or about 30 LPM to about 80 LPM, or about 35 LPM to about 75 LPM, or about 40 LPM to about 70 LPM, or about 45 LPM to about 65 LPM, or about 50 LPM to about 60 LPM. For example, according to the different embodiments and configurations described herein, the flow rate of gas supplied or provided to the interface via the system or from a flow source may include, but is not limited to, at least about 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150 LPM or greater, and the available range may be selected as any of these values ​​(e.g., about 20 LPM to about 90 LPM, about 40 LPM to about 70 LPM, about 40 LPM to about 80 LPM, about 50 LPM to about 80 LPM, about 60 LPM to about 80 LPM, about 70 LPM to about 100 LPM, about 70 LPM to about 80 LPM).

[0384] • In some configurations, the typical flow rate for adults typically ranges from, but is not limited to, about 15 liters per minute (LPM) to about 70 liters per minute or greater. The typical flow rate for pediatric patients (such as newborns, infants, and children) typically ranges from, but is not limited to, about 1 liter per minute per kilogram of patient weight to about 3 liters per minute per kilogram of patient weight or greater. High flow rates may also optionally include gas mixture compositions comprising supplemental oxygen and / or administration of therapeutic drugs. The flow rate used to achieve a “high flow rate” can be any of the flow rates listed below. For example, in some configurations, for adult patients, “high-flow respiratory support” may refer to delivering gas to the patient at a flow rate greater than or equal to about 10 liters per minute (10 LPM), such as between about 10 LPM and about 100 LPM, or between about 15 LPM and about 95 LPM, or between about 20 LPM and about 90 LPM, or between about 25 LPM and about 75 LPM, or between about 25 LPM and about 85 LPM, or between about 30 LPM and about 80 LPM, or between about 35 LPM and about 75 LPM, or between about 40 LPM and about 70 LPM, or between about 45 LPM and about 65 LPM, or between about 50 LPM and about 60 LPM. In some configurations, for neonatal, infant, or pediatric patients, "high-flow respiratory support" may refer to delivering gas to the patient at a flow rate greater than 1 LPM, such as between about 1 LPM and about 25 LPM, or between about 2 LPM and about 25 LPM, or between about 2 LPM and about 5 LPM, or between about 5 LPM and about 25 LPM, or between about 5 LPM and about 10 LPM, or between about 10 LPM and about 25 LPM, or between about 10 LPM and about 20 LPM, or between about 10 LPM and 15 LPM, or between about 20 LPM and 25 LPM. High-flow respiratory support devices for adult, neonatal, infant, or pediatric patients may deliver gas to the patient at a flow rate between about 1 LPM and about 100 LPM, or at any of the sub-ranges outlined above.

[0385] • The flow therapy device 10 can deliver oxygen (e.g., FdO2) at any concentration up to 100% at any flow rate between about 1 LPM and about 100 LPM. In some configurations, any of these flow rates can be combined with oxygen concentrations (FdO2) of about 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some combinations, the flow rate can be between about 25 LPM and 75 LPM and combined with oxygen concentrations (FdO2) of about 20% to 30%, 21% to 30%, 21% to 40%, 30% to 40%, 40% to 50%, 50% to 60%, 60% to 70%, 70% to 80%, 80% to 90%, and 90% to 100%. In some configurations, the flow therapy device 10 may include safety thresholds when operating in manual mode to prevent the user from delivering too much oxygen to the patient.

[0386] • The flow rate for “high flow” treatment of preterm infants / toddlers (weighing between about 1 kg and about 30 kg) may vary. Therapeutic flow rates can be set from 0.4 L / min / kg to 8 L / min / kg, with a minimum of about 0.5 L / min and a maximum of about 25 L / min. For patients weighing less than 2 kg, the maximum flow rate is set to 8 L / min. Oscillating flow rates are set from 0.05 to 2 L / min / kg, with a preferred range of 0.1 to 1 L / min / kg, and another preferred range of 0.2 to 0.8 L / min / kg.

[0387] In the "high flow" configuration, the delivered gas will be selected based on the intended use, such as treatment, some examples of which are given above. The delivered gas may include a certain percentage of oxygen. In some configurations, the percentage of oxygen in the delivered gas may be about 15% to about 100%, 20% to about 100%, or about 30% to about 100%, or about 40% to about 100%, or about 50% to about 100%, or about 60% to about 100%, or about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100%, or about 100%, or 100%.

[0388] 1. Overview

[0389] The embodiments described herein provide apparatus, systems, and methods for assessing a patient's respiratory status (e.g., normal, distressed, worsening or improving, stable) ("assessment phase" or "diagnosis phase") and, based on this assessment, optionally taking appropriate respiratory support actions ("respiratory support phase"). For example, if the patient is in respiratory distress, or develops respiratory failure during the respiratory support phase, escalation of respiratory support can be performed to slow further deterioration of the respiratory status. This assessment is preferably performed while the patient is receiving respiratory support (e.g., high-flow respiratory support, NIV, invasive ventilation, etc.).

[0390] During the assessment phase, the respiratory index can be determined. The respiratory index is an indicator of a patient's breathing, and the respiratory index (and / or changes in the respiratory index) can be used to determine the patient's (current) respiratory status and / or changes in respiratory status, thereby determining the respiratory condition.

[0391] Breathing status can be “normal” or “respiratory distress”. Respiratory distress can range from mild to severe, as described later. The respiratory index can indicate whether a patient is tending to or experiencing: a respiratory distress episode or is in respiratory distress, and / or is experiencing or tending to worsen respiratory distress. (Worsening respiratory distress may lead to the risk of respiratory failure or actual respiratory failure, which is a severe form of respiratory distress).

[0392] Based on the patient's breathing, respiratory index, and / or respiratory status, it can be determined whether escalation of respiratory support is desired to improve the patient's respiratory status / alleviate respiratory distress (during the respiratory support phase). This may be to prevent further deterioration of respiratory distress (stabilization) or to allow the patient to recover from respiratory distress and return to normal breathing. For example, if the patient is in mild respiratory distress, escalation of respiratory support may be used to reduce the chance of the patient worsening to a more severe level of respiratory distress (such as the risk of respiratory failure or actual respiratory failure). Alternatively, if the patient is already at risk of respiratory failure (or has already experienced respiratory failure), escalation of respiratory support reduces the risk of respiratory failure occurring (or persisting) and / or the negative health outcomes associated with respiratory failure.

[0393] However, escalating respiratory support (such as increasing high-flow respiratory support, providing NIV pressure respiratory support, or providing invasive respiratory support) carries its own risks, and therefore, unnecessary escalation is not expected. Similarly, when respiratory distress improves, de-escalation is generally expected to eliminate the risks associated with escalation. Among other things, the assessment phase is used to identify early signs of deterioration in a patient's respiratory condition, allowing for proactive action rather than premature and unnecessary intervention. Early escalation of respiratory support can improve health outcomes, while delay carries the risk of negative health outcomes.

[0394] For example, the patient may be receiving basic respiratory support in the form of high-flow respiratory support (such as nasal high-flow or tracheal high-flow respiratory support). The assessment phase can be used to determine whether escalating respiratory support would be beneficial to the patient and whether it should be implemented.

[0395] In one example, escalating respiratory support may include upgrading to high-flow respiratory support. This can take the form of increasing high-flow respiratory support parameters (such as flow rate, O2 concentration, humidity, etc.), while de-escalating respiratory support may include reducing support parameters. For example, this escalation might occur when a patient is determined to be in respiratory distress and deteriorating based on the respiratory index, but is not yet at high risk of respiratory failure. Upgrading to high-flow respiratory support can stabilize or even improve a patient's respiratory condition, meaning the risk of respiratory failure (and therefore even more invasive escalations) is avoided.

[0396] As another example, escalation of respiratory support can include a shift to more invasive respiratory support. This could be an escalation to NIV respiratory support or invasive respiratory support. This may occur immediately or after an escalation to high-flow respiratory support. In the case of nasal / tracheal high-flow respiratory support, escalation of respiratory support can also include a shift from nasal high-flow to invasive ventilation, such as providing mechanical ventilation to an intubated patient. Degradation can include:

[0397] If in use, remove invasive respiratory support and return to basic respiratory support (e.g., NIV respiratory support or high-flow nasal transfusion), or

[0398] If in use, remove NIV respiratory support and return to basic respiratory support (e.g., high-flow nasal cannula), or

[0399] Degrade the nasal high-flow rate when in use.

[0400] Alternatively, as another example of more invasive respiratory support, escalation of respiratory support may include transferring the patient to non-invasive (“NIV”) pressure respiratory support. This may occur immediately or after an escalation to high-flow respiratory support. Degradation may include removing NIV pressure respiratory support and returning to basic respiratory support (e.g., high-flow nasal support).

[0401] Respiratory support may also include, for example, the use of humidification via high-flow nasal, high-flow tracheal, and / or NIV pressure respiratory support. As another example, escalation of respiratory support may include providing or upgrading humidification. This may be for therapeutic and / or comfort purposes and may replace or supplement any of the other escalations described. Degradation may include removing or reducing humidification.

[0402] Therefore, this embodiment utilizes changes in respiratory indices (such as trends in respiratory indices) to help determine when it is appropriate to escalate and / or de-escalate respiratory support. Using respiratory index trends helps to improve the timing of treatment escalation as needed, in order to help improve patient stability (and improve respiratory index, condition, etc.).

[0403] This provides improved health outcomes (including improved respiratory index, condition, etc.) because escalated respiratory support is provided where the benefits of providing escalated support likely outweigh the risks of providing it.

[0404] Typically, the described embodiments relate to basic respiratory support in the form of nasal high-flow respiratory support and / or tracheal high-flow respiratory support (which is a high-flow gas provided to the patient to support respiratory function). Preferably, the high-flow respiratory support includes humidification for patient comfort.

[0405] Generally, this apparatus and method include one or more of the following:

[0406] Evaluation methods

[0407] Performed by the evaluation device, and

[0408] Optionally, methods and / or devices for providing respiratory support based on the results of an assessment method.

[0409] This allows clinicians and / or devices to determine appropriate changes in respiratory status / condition, such as changes in respiratory distress or worsening towards respiratory failure, and allows clinicians and / or ventilators to escalate respiratory support more quickly. For example, patients can be intubated and given mechanical ventilation much earlier compared to current diagnostic methods. The method described in this article allows for early detection of deterioration in a patient's respiratory status, such as an increase in respiratory distress or an indication of potential worsening of respiratory distress (whether mild or severe). This allows clinicians / ventilators to escalate respiratory support earlier, thereby increasing the chances of recovery and survival.

[0410] refer to Figure 1 Generally, the combination of this device and / or method can:

[0411] a) Determine during the assessment phase:

[0412] Respiratory index, and

[0413] Determine the patient's respiratory status and / or whether a change in respiratory support is needed based on changes in the respiratory index.

[0414] and

[0415] b) During the respiratory support phase, based on the assessment phase,

[0416] Implement respiratory support changes using a ventilator (by a clinician and / or the ventilator).

[0417] It is not necessary to have both a) and b) at the same time. For example, it may be possible to implement only the evaluation phase a).

[0418] The evaluation phase may include one or more of the following:

[0419] • Assess respiratory status and determine whether it is normal, abnormal, worsening, stable, or improving.

[0420] • Assess whether changes in respiratory support are necessary (as a result of assessing respiratory status).

[0421] • If necessary, assess what changes in respiratory support are needed (e.g., escalation, de-escalation, increase or decrease of high-flow therapy, escalation to NIV or invasive ventilation, de-escalation from NIV or invasive ventilation, etc.).

[0422] The implementation method and respiratory support phase may include:

[0423] • For example, indicating any of the above results during the evaluation phase through alerts, alarms, messages, or other indicators, and / or

[0424] • Make any changes identified during the evaluation phase.

[0425] The evaluation phase can be implemented in the following ways:

[0426] • Individual clinician

[0427] • No need for one or more assessment devices, treatment devices and / or other devices for clinicians.

[0428] • Or both a clinician and one or more devices.

[0429] Similarly, the respiratory support phase can be implemented as follows:

[0430] • Individual clinician

[0431] • No need for one or more assessment devices, treatment devices and / or other devices for clinicians.

[0432] • Or both a clinician and one or more devices.

[0433] A respiratory index (“RI”) is determined, and then optionally, the patient’s respiratory status is assessed based on changes in the RI. Then, based on changes in the RI and / or the patient’s respiratory status (which may be displayed to a clinician, for example), a decision is made optionally whether a change (e.g., escalation or de-escalation) in respiratory support is needed, and if so, what change is required. Optionally, the breathing apparatus is configured to provide support automatically or through clinician intervention.

[0434] The respiratory index can be determined based on / is a function of one or more lung mechanics parameters (such as respiratory rate, expiratory time, minute ventilation), and one or more oxygenation parameters (such as SpO2, FiO2, FdO2, O2 fraction). These parameters can be calculated by the controller of the respiratory device based on signals / measurements from one or more sensors associated with the respiratory device.

[0435] Alternatively, the respiratory index can be characterized as follows: it can be a unitless number f(x) that is a function of one or more of the following:

[0436] • Patient parameters, which may include:

[0437] o Physiological parameters (which may include respiratory parameters), and

[0438] o Treatment parameters (treatment provided to the patient);

[0439] and

[0440] • Breathing device parameters (which may include operating parameters).

[0441] Physiological parameters may include lung mechanics parameters and / or oxygenation parameters.

[0442] Typically, the respiratory index can be calculated using one or more of SpO2 (a patient physiological parameter), FiO2 (a patient treatment parameter), and respiratory rate (a patient physiological parameter). Note that FdO2 can be used as a substitute for FiO2. FdO2 is the fraction of oxygen delivered, i.e., the O2 concentration of the gas flow, while FiO2 is the fraction of oxygen inhaled. Their values ​​are related and similar, but not identical—if the gas flow is high enough and the patient is not inhaling ambient air, FdO2 will be essentially equivalent to FiO2, and therefore FdO2 can be used as a substitute for FiO2. FdO2 is a respiratory device parameter. For oxygen-providing respiratory devices, the oxygen concentration provided by the device (an operating parameter) can be closely related to FiO2 and can be used as a substitute for FiO2. However, other parameters can also be used. The respiratory index can be a function of any set of parameters that provide respiratory indications, based on which the patient's respiratory status (such as the risk of respiratory failure) can be determined.

[0443] For example, the respiratory index RI can typically be defined as a function of the following:

[0444] • A parameter representing lung mechanics and a parameter representing oxygen exchange, RR = f(LM, O), or

[0445] • Respiratory rate (RR), for example, RI = (RR), or,

[0446] • A function of respiratory rate and FiO2, such as RI = (FiO2, RR), or

[0447] • A function of respiratory rate, FiO2, and SpO2, for example, RI = (SpO2, FiO2, RR).

[0448] •

[0449] In one example, the respiratory index can be ROX, which is defined as:

[0450] ROX = (SpO2 / FiO2) / RR

[0451] in,

[0452] SpO2 is the set oxygen saturation (%) in a patient's blood, or alternatively, the actual oxygen saturation (%) in a patient's blood.

[0453] FiO2 is the fraction of oxygen inhaled by the patient (%) (FdO2 can be used as a substitute), and

[0454] Respiratory rate is the rate of breathing measured in breaths per minute.

[0455] Changes in the respiratory index (RI) (e.g., changes over time) can be used to determine a patient's respiratory status. Based on the respiratory status, it can be optionally determined whether respiratory support needs to be changed. Alternatively, based on changes in the respiratory index itself, it can be optionally determined whether respiratory support needs to be changed.

[0456] For example, changes in the respiratory index itself can provide an indication of whether a change in respiratory support is needed. Alternatively, a relationship (“relationship information”) between changes in the respiratory index and some other information can provide this determination; for example, parameters (such as predetermined or other thresholds) can provide this determination. Multiple respiratory index values ​​can be used for determination (e.g., multiple respiratory index values ​​can be determined over time, and a trend can be determined by the desired respiratory change). A relationship between multiple respiratory index values ​​or some information, such as a parameter summarizing the multiple values ​​and another parameter, can be used. Various options exist for determining whether a change in respiratory support is needed, but optionally these options are based on the respiratory index among other information.

[0457] Viewing changes in the respiratory index over time can include examining multiple time instances of the respiratory index's change over time. For example, for each of multiple time points, the (e.g., instantaneous) change of the respiratory index over time (at that time point) can be determined. This change in the respiratory index (over time) (e.g., instantaneous) over multiple time points can be used to determine a patient's respiratory status. That is, for example, the derivative of the respiratory index over time can be obtained at multiple times, and the derivative of the respiratory index over time can be differentiated over multiple time instances to give the second derivative of the respiratory index over time. For example, this could be the acceleration of changes in the following: respiratory index, patient parameters, patient status, and / or patient condition. The first and / or second derivatives can be viewed or compared with relational information (e.g., slope thresholds or other change indicator thresholds) to assess the patient's respiratory status. For example, the derivative of the respiratory index over time and / or the second derivative of the respiratory index over time can be displayed in numerical and / or graphical form. Monitoring changes in the respiratory index over time at multiple time points includes, for multiple time points: viewing the displayed changes in the respiratory index over time and / or calculating and comparing these changes with relational information. Changes in the respiratory index over time can be indicated by change indicators.

[0458] As an example, the desired option is to examine the respiratory index over time and determine whether the respiratory index shows a trend of increasing, decreasing, or changing in some other way, or in other respects relative to a threshold (e.g., as...). Figure 2 The relationship data (shown) exhibits a certain relationship change. Based on any of the above, an indication of respiratory status can be determined, and respiratory support can be changed accordingly. Alternatively, the respiratory index and its trend relative to a threshold (such as its magnitude and direction) can be used to directly determine whether a change in respiratory support is needed. An assessment using the respiratory index can provide a trigger for changes in respiratory support.

[0459] Thresholds or other relationship information can be determined through experimental data, clinical studies, user input, calculation, and / or other means. Thresholds or other relationships can be predetermined or determined in real time, or input or otherwise provided. Thresholds or other relationships can be fixed or vary based on other parameters (e.g., they can vary over time, or they can vary based on other parameters used in or alternatively not used in the respiratory index).

[0460] Non-limiting examples of thresholds may be a respiratory index threshold and / or a slope threshold (or other "indicator of change" thresholds, depending on the indicator used to describe changes in the respiratory index), which depicts normal breathing versus poor breathing, and the slope threshold may depict trends of improvement versus deterioration in the respiratory index. One or more respiratory index or slope thresholds may exist.

[0461] As some examples, changes in the respiratory index and / or respiratory index can be assessed using one or a combination of the following:

[0462] • Compare the respiratory index (e.g., ROX) to one or more respiratory index thresholds.

[0463] • Compare the change in respiratory index over time with one or more respiratory index thresholds.

[0464] • Compare the measure of change in the respiratory index over time (e.g., vector, slope, or other quantity and / or direction measure) with a threshold (e.g., one or more slope thresholds).

[0465] • Compare the respiratory index to one of the patient parameters or a function of the patient parameters (such as SpO2, FiO2, etc.), such as in a graphical and / or numerical form that can be displayed and monitored.

[0466] • Compare the magnitude of the respiratory index over time (decreasing or increasing) with (multiple) thresholds. For example, a slow (i.e., small slope) but significant difference (i.e., large Δ in ROX) between the respiratory index at time = 1 and the respiratory index at time = 2 may indicate deterioration. Similarly, a large and slow positive change may be an indication of improvement.

[0467] Compare the change of any of the above terms with time as the first derivative with some relational data, and / or compare the change with time (acceleration of change) as the second derivative with some relation.

[0468] The above example involves using the respiratory index to determine a patient's respiratory status.

[0469] In an alternative approach, a respiratory index and patient parameters (which can be components of the respiratory index) can be used for assessment. Therefore, more generally, one or more respiratory parameters can be used in conjunction with the respiratory index to assess a patient's condition. This can be particularly useful when clinicians are conducting an assessment and wish to gain a deeper understanding of the causes of the respiratory condition. The respiratory index itself can indicate a respiratory condition (e.g., a change in respiratory status) but may not indicate why that change occurred. Instead, patient parameters such as respiratory rate, FiO2, and / or SpO2 can provide insight into this. This will be described in more detail later. The respiratory index, patient parameters, and any other information related to the patient's condition or status can be referred to as "assessment information." Assessment criteria can be used to aid in the assessment.

[0470] The above are not limiting. More generally, respiratory status assessment can be performed in the following ways:

[0471] The evaluation information, evaluation criteria, and / or relational information (static or dynamic and / or 2D or 3D, such as time displayed on an axis) are displayed on a monitor in the form of numbers, charts, and / or other graphical indicators, and are viewed by a person.

[0472] A device for comparing the above content with relational information.

[0473] Using the respiratory index to optionally determine whether changes in respiratory support are needed can be termed the "diagnostic phase" or alternatively, the "triggering phase." Alternatively, the assessment can be considered the diagnostic phase, regardless of whether a course of action has been determined.

[0474] In many cases, clinicians assess respiratory status based on information displayed on assessment devices. Through various combinations of graphical and numerical representations of parameters and respiratory indices, trained clinicians can interpret these to gain indications of the respiratory status, particularly its direction and the possible interventions. This allows clinicians to make rapid decisions in situations where many patients may be monitored simultaneously (e.g., in the emergency room). These assessments may be aided by instructions from the assessment device (alarms, messages, etc.) and / or by automated decisions made by the device itself. Similarly, home care can achieve the same benefits, allowing clinicians remotely monitoring multiple patients to quickly assess those deteriorating or potentially facing respiratory failure.

[0475] Traditionally, clinicians have had to rely on subjective measurements based on limited information to assess patients' respiratory status. Furthermore, they have often had to use invasive testing methods. This embodiment improves upon this. Generally, assessments can be performed by displaying various combinations of respiratory indices, variability indicators, patient parameters, and / or thresholds graphically and / or numerically, providing support for clinicians' decision-making. Assessments can also be conducted using numerical information, two- or three-dimensional charts, animations, moving graphs, zoom-in and depth information, and contextual information. Providing visual, contextual, and / or accessible information will assist clinicians in making quick, objective decisions, rather than relying solely on subjective considerations. This also allows for exception handling—addressing the issues of those most in need first. Examples will be described later in this document.

[0476] The assessment (determination) is conducted over a period of time. For example, a period can be defined as a treatment period, a day or a portion of a day, a night or a portion of a night, a sub-period, or a certain length of time (e.g., 5 hours). Typically, comparisons are made relative to thresholds and / or previously determined respiratory index parameters within the same period. That is, the assessment is based on what is happening in real time. Assessments can be performed by time intervals, where each interval is a part of a period. For example, assessments can be performed by minutes, tens of minutes, hours, etc. Within this time frame, the assessment may include considering changes in the respiratory index and / or component parameters between different time intervals. This assessment may be based on changes in the respiratory index and / or component parameters individually and / or compared with relational information. Alternatively, assessments (determinations) can be performed within multiple time intervals and / or across multiple time intervals. For example, within multiple time intervals, the assessment may include considering changes in the respiratory index and / or component parameters from one time interval to another (and / or within a period). This assessment may be based on changes in the respiratory index and / or component parameters individually and / or compared with relational information.

[0477] In a home setting, clinicians are unlikely to be with the patient. In this case, the patient's respiratory index / condition can be monitored remotely. This can be achieved, for example, through an assessment device that remotely provides assessment information to the clinician, and / or through a clinician possessing the assessment device, which communicates remotely with the respiratory support device and / or any other devices (such as sensors) required for the assessment. The respiratory support device and / or assessment device will have communication functions 55B, 55A to enable the clinician to monitor the patient remotely. For example, the remote assessment device can calculate the respiratory index and / or changes in the respiratory index based on measurements from the respiratory support device that are identical to those from the patient. The respiratory index can be calculated from the respiratory index values ​​provided to the clinician. This processing can be performed on the respiratory device, and the processed information can be provided to the clinician, and / or alternatively, the clinician, as the assessment device, receives the raw data and makes an assessment. A remote patient monitoring system 57 may exist, for example, which includes at least a remote server 57 that receives information from the assessment device and / or respiratory support device via a network 56 accessible to the clinician. For example, the clinician can access the information via a web browser / web server. The assessment device can be a server, a breathing device, a mobile device, and / or any other assessment device.

[0478] The remote patient monitoring system 57 further includes one or more databases, a reporting engine for generating patient reports, and other suitable components that allow monitoring of patients and generating patient reports (e.g., including the use of respiratory support devices, treatment settings, etc.). The remote patient monitoring system 57 allows clinicians to remotely manage multiple patients, for example, allowing management of patients at home (i.e., outside the hospital).

[0479] Respiratory index data can be provided to a remote patient monitoring system 57. Respiratory index measurements and changes in the respiratory index can be incorporated into a patient report, which includes measured patient parameters such as SpO2, flow rate, humidity setpoint, and usage time, as well as the respiratory index and its changes over time.

[0480] Changes in the respiratory index allow clinicians to assess the effectiveness of the current treatment being administered and also allow them to modify the treatment being provided. In one example, the operating parameters of the respiratory support device (e.g., prescription settings) can be remotely updated based on changes in the respiratory index. The remote monitoring system can use changes in the respiratory index to generate alerts or messages to clinicians and patients. Based on changes in the respiratory index, the remote patient monitoring system 57 can automatically change treatment settings, such as remotely changing high-flow treatment settings, such as oxygen fraction (i.e., oxygen % in the gas) and / or flow rate and / or humidity (e.g., dew point or relative humidity or absolute humidity). Examples of how treatment settings (i.e., treatment parameters) can be changed will be described later. Treatment settings, particularly, for example, high-flow respiratory support device settings, can be changed and transmitted as a new prescription to the respiratory support device 10 via network 56. The respiratory support device 10 can incorporate these changes and begin operating based on the new prescription (i.e., the updated treatment settings, i.e., the updated treatment parameters). Alternatively, clinicians or healthcare professionals can change treatment settings at the remote monitoring system 57 based on changes in the respiratory index. These changes made by clinicians are transmitted to the respiratory support device 10 via network 56. The new settings are transmitted as a new prescription. The respiratory support device makes the changes defined in the new prescription (i.e., updates its treatment settings) to operate according to the new settings.

[0481] The process of monitoring the respiratory index can continue. This remote monitoring provides effective out-of-hospital monitoring of the patient. It allows clinicians to assess the patient's respiratory status and determine whether high-flow therapy is beneficial by examining changes in the respiratory index. Changes in the respiratory index indicate changes in the patient's respiratory status. This disclosure provides effective out-of-hospital monitoring of the patient. It further allows for remote adjustment of the treatment settings of the respiratory support device associated with the patient based on the assessed changes in the respiratory index.

[0482] Once a trigger is established, changes in respiratory support are identified. These changes can be determined by a clinician and / or an assessment device.

[0483] This may lead to one or more changes in the use of respiratory support devices, namely:

[0484] Operational changes (automatic or clinician-initiated), such as increasing the flow rate or oxygen fraction provided to the patient;

[0485] Variations in treatment (such as intubating the patient instead of providing high flow through an unsealed cannula) include providing entirely different treatments, such as ventilation.

[0486] Provide clinicians with the following instructions (e.g., warnings, alerts, and / or instructions):

[0487] Changes are needed.

[0488] How and / or when to change treatment, and / or

[0489] Configurational changes.

[0490] These are not limitations on possible options for changing breathing support.

[0491] As part of the evaluation phase, whether performed by a person and / or device, instructions and / or changes during treatment can be used to indicate what has been determined and / or has been changed in treatment and / or should be changed in treatment and / or what changes should be made to treatment. For example:

[0492] Audible alarms – These can be used to indicate determinations made, what those determinations are (e.g., worsening), and / or whether or not certain treatment changes have occurred. Alarms can be issued on the treatment device or a separate device (e.g., a doctor's mobile phone). Different sounds can indicate different patient states (or different changes in patient state).

[0493] Visual alerts – These can be used to indicate what has been determined, what has been determined (e.g., worsening), and / or what changes in treatment will or may have occurred. Alerts can be issued on the treatment device or on a separate device. Different visual outputs can indicate different patient states (or different changes in patient state).

[0494] Messages – These can be used to indicate determinations made, what those determinations are (e.g., deterioration), and / or whether certain treatment changes will or may have occurred. The message can be sent to one or more recipients / devices (each recipient / device may receive a different message or the same message). The message may include warnings and / or suggestions to change one or more device settings. The message may include suggestions on which (multiple) settings should be changed to (multiple) specific values. Calculations for these specific values ​​can be performed on the treatment device or on individual devices.

[0495] Automatic adjustment of device settings (multiple): After determination (e.g., a worsening patient condition), if the index value / slope indicates that the patient requires different support (e.g., more flow), the controller associated with the device can change one or more settings. Calculations for appropriate changes can be performed on the treatment device or on individual devices.

[0496] Device shutdown – Once determined (e.g., patient condition improves), if the index value / slope indicates that the patient no longer needs treatment (i.e., if their index value / slope is on the low-risk side of the threshold and / or is progressing in a positive direction), the controller associated with the device can shut down the treatment / device.

[0497] The above content can be provided on the device itself or remotely provided to another device, in which clinicians can work remotely.

[0498] This list is not exhaustive.

[0499] The assessment device may be near or held by the clinician. This could be in a hospital setting, for example. Alternatively, the assessment device may be located away from the clinician. It will have communication capabilities to communicate with a remote clinician. This could be in a home setting, for example, where the clinician is not with the patient / ventilation device and / or assessment device. In another alternative, the ventilation device may be with the patient, but the assessment device may be located away from a remote clinician.

[0500] As described above, the described embodiments will generally involve (at least initially) the use of the nasal or tracheal high-flow respiratory support device 10, typically as follows: Figure 3 As shown. However, this is not limiting; for example, the embodiment can be used for NIV or other respiratory devices. There is a device 10 providing respiratory support and a device 20 determining the diagnosis. These can be the same device (e.g., a respiratory support device) or different devices (e.g., a respiratory support device and a mobile device). If it is a separate device (e.g.... Figure 3 As shown in the figure, they can together form a respiratory assessment and support system 1.

[0501] For example, refer to Figure 3 A respiratory support device may be present, which has a controller (also referred to as a processor) 19, an I / O interface 54, a flow generator 50, and a humidifier 52. The respiratory support device can be configured to receive air and / or supplemental gases such as oxygen. It can provide gas flow to the patient through a breathing tube 5 and a patient interface 51 (e.g., an unsealed interface (such as, but not limited to, a nasal cannula) or an endotracheal interface). The controller 19 can operate the device based on inputs from sensors 11 in or connected to the system to provide the desired flow rate and / or pressure, temperature, humidity, oxygen or other gas fractions, etc. These can be non-invasive sensors.

[0502] The device also has (integrated therein) and / or is connected to sensor 12, which provides:

[0503] • Physiological parameters (which may include respiratory parameters), and

[0504] • Breathing device parameters (which may include operating parameters)

[0505] This is to obtain parameters for operating the device (such as temperature, humidity, pressure, and flow sensors) and parameters for determining the respiratory index (such as SpO2, FiO2 (or FdO2, the fraction of oxygen delivered to the patient), and respiratory rate). Any reference to FiO2 can be replaced with a reference to FdO2, O2 fraction, or any other oxygenation parameter, and vice versa—these variants are interchangeable. Physiological parameters may include lung mechanics parameters and / or oxygenation parameters.

[0506] As a possible example:

[0507] Note that any of these can be wearable (see, for example, [link to relevant documentation]). Figure 6 54E in the middle.

[0508] For SpO2, the device can be connected to a physiological sensor, such as a pulse oximeter or other blood oxygenation sensor. This can be a wearable device, for example, see [link to relevant documentation]. Figure 6 The 54E model can include a wireless pulse oximeter (SpO2 sensor). Wireless pulse oximeters can communicate via Bluetooth, infrared, or other communication protocols. Wireless SpO2 allows patient mobility; for example, a patient can move around while using the SpO2 sensor, and the assessment device still receives the measurement results. The SpO2 sensor is connected to a respiratory device or assessment device. The respiratory device is a non-invasive sensing unit that also provides respiratory support. The respiratory device can process the sensor signal and calculate the exponential / change in the respiratory index.

[0509] Alternatively, changes in the respiratory index can be monitored remotely.

[0510] For the respiratory rate, this can be measured / determined using a pressure sensor, a flow sensor, or any other respiratory rate sensor capable of determining the respiratory rate. For example, the respiratory rate can be calculated using a flow sensor, and then a mathematical process can be applied to the flow sensor readings to determine the respiratory rate. In one example, the respiratory support device is configured to use a flow sensor, which is processed to filter the flow signal from the blower. The frequency response (e.g., Fast Fourier Transform or other frequency response) of the filtered flow signal is determined to calculate the peak frequency. The peak frequency corresponds to the respiratory rate. Other frequency analysis techniques can be applied to the flow signal to determine the respiratory rate. For example, frequency analysis can identify one or more local maxima and identify the maximum value of the highest magnitude as the respiratory rate. Alternatively, a motor speed signal can be processed (e.g., filtered) based on the flow signal and frequency analysis can be performed, where the local maxima and the frequency with the highest magnitude are the respiratory rate. Alternatively, the Georgel algorithm / Geortzel analysis can be used for frequency analysis.

[0511] Alternatively, respiratory rate measurement can be achieved by placing a temperature sensor at the intubation site (e.g., integrated into the intubation tube) and determining the temperature difference. The temperature difference indicates the respiratory rate. A similar measurement can be achieved using a pressure or flow sensor at the intubation site, and changes in pressure or flow can indicate the respiratory rate.

[0512] Alternatively, the respiratory rate can be determined by other sensors, such as (but not limited to) a pulse oximeter, respiratory rate sensor, or pressure sensor in the device; or a pressure sensor or flow sensor in the tubing or patient interface; or a chest strap sensor or any combination thereof. One or more of these devices may optionally be wearable devices or activity recording devices configured to measure respiratory rate (see, for example, see...). Figure 6 (54E in the original text). Wearable devices can be, for example, wrist-worn devices that communicate wirelessly with a flow generator or smartphone.

[0513] For example, respiratory rate is calculated based on a pressure signal. This pressure signal can be measured by a pressure sensor at the patient interface or using a pressure path; the sensor can be located within the device, and the pressure value can be transmitted back to the device. Pressure differences can be processed, and the respiratory rate can be calculated by measuring the number of times the zero point is crossed. A similar method can be used with flow readings. The cyclic nature of the P or F signal can be processed to obtain the respiratory rate.

[0514] Alternatively, a suitable sensor (e.g., a spirometer) can be used to measure gas exchange (e.g., CO2 exchange) at the interface to determine the respiratory rate. Alternatively, photoplethysmography or electrocardiography can be used for measurement.

[0515] Alternatively, any sensor, such as an accelerometer, can be placed on the chest or abdominal wall to measure respiratory rate. The sensor can be separated from the device via wireless communication.

[0516] Alternatively, the respiratory rate may be determined as described in US 202101133796, which is incorporated herein by reference in its entirety.

[0517] In one example, expiratory time can be calculated based on a flow sensor signal, a pressure signal, or a combination of flow and pressure sensor signals. Below is an example of expiratory time calculation for an unsealed system that provides high-flow respiratory support via an unsealed cannula (e.g., device 10 disclosed herein). The method is performed by a controller. The controller of the device receives a flow signal representing the gas flow rate. The controller preprocesses and filters the flow rate signal. The controller then determines a primary respiratory parameter ratio, such as the ratio between the inspiratory time and total respiratory time of the patient's respiratory cycle, and / or the expiratory time and total respiratory time. The respiratory rate is determined or received. The respiratory rate can be determined as described above or received manually at the respiratory support device. The device uses the respiratory parameter ratio and the respiratory rate to determine the expiratory time. Additional minute ventilation can be determined based on the respiratory rate and the measured flow rate. In a further example, expiratory time can be calculated as described in U.S. Provisional Application US 63 / 146,184, filed February 5, 2021, the contents of which are incorporated herein by reference in their entirety.

[0518] The measured or calculated respiratory rate is stored in the NHF therapy device. FiO2 readings over a period of time are also stored in the NHF device. Alternatively or additionally, these readings and / or any other readings may be transferred to and stored in another device, such as a smartphone.

[0519] Alternatively, the respiratory rate can be manually entered via the user interface.

[0520] Other options are also possible.

[0521] FiO2 can be obtained by measuring FdO2 or another measure of O2 concentration in the gas stream using any suitable sensor (e.g., an ultrasonic sensor) or other gas concentration sensor. For example, this can be done with a flow sensor and an O2 concentration sensor, where optionally, the flow sensor is an inline flow sensor. This sensor can be located downstream of the mixer of ambient air and O2.

[0522] An ultrasonic sensor can be used to rapidly measure FiO2, or FdO2. This allows for rapid response and control of oxygen in the airflow. As previously mentioned, FdO2 can be a substitute for FiO2. The measured FdO2 is reported and displayed as FiO2 on the device's screen. During high-flow-rate respiratory support, the flow rate is high enough that ambient air is not entrained at the nasal cannula during the patient's inspiration. Therefore, the delivered oxygen fraction FdO2 is expressed as equivalent to FiO2 (the fraction of oxygen inhaled). The ultrasonic (i.e., ultrasound) sensor allows for rapid response—rapid measurement and therefore rapid response. A valve on the oxygen inlet can be controlled to alter the oxygen fraction in the airflow (thus affecting FdO2).

[0523] Any of the above parameters can be manually entered instead, and the respiratory index can be calculated from them.

[0524] The assessment device and / or respiratory support device may also have corresponding communication capabilities. This could be a modem or other transceiver. This allows the assessment device and respiratory support device to communicate with each other, whether remotely or in the same location, and / or also with a remote clinician. This allows the clinician to remotely monitor the patient and their respiratory support and / or changes as needed. A remote server may be present, receiving information from the assessment device and / or respiratory support device that is accessible to the clinician. For example, the clinician may access the information via a web browser / web server. The assessment device can be a server, a respiratory device, a mobile device, and / or any other assessment device.

[0525] Typically, referencing, for example Figure 3Describes a high-flow-rate breathing device 10. Generally, the device includes a main housing 10 that houses a flow generator 50 arranged in a motor / impeller configuration, an optional humidifier 52, a controller 19, and a user I / O interface (including, for example, a display and input devices such as buttons, a touchscreen, etc.). An input of supplemental oxygen or other supplemental gases can be provided. A valve (e.g., a proportional valve) in fluid communication with the supplemental gas inlet can be provided and configured to control the amount of supplemental gas introduced into the device. The screen may be removable. The controller 19 is configured or programmed to control components of the device, including: operating the flow generator to generate a flow rate of gas (gas flow) for delivery to a patient; operating the humidifier (if present) to humidify and / or heat the generated gas flow; receiving user input from the I / O interface for reconfiguration and / or user-defined operations of the device; and outputting information to the user (e.g., on the display). The user can be a patient, a healthcare professional, or any other person interested in using the device. The patient breathing tube is connected to the gas flow outlet in the housing of the flow therapy device and to a patient interface 51 (such as a nasal cannula) with a manifold and a nasal fork. The patient breathing tube may have a heating wire 5 to heat the gas flow passing through to the patient.

[0526] Examples of high-flow-rate breathing devices are disclosed in international application PCT / NZ2016 / 050193, filed December 2, 2016, entitled “Flow Path Sensing for Flow Therapy Apparatus,” and international application PCT / IB2016 / 053761, filed June 24, 2016, entitled “Breathing Assistance Apparatus,” both of which are incorporated herein by reference in their entirety. Examples of configurations of high-flow-rate breathing devices that can be used with the aspects of this disclosure are further discussed in detail below.

[0527] The respiratory support device can determine the respiratory index and / or changes in the respiratory index and make an assessment of any changes that lead to respiratory support. Alternatively, the relevant information can be transmitted to a separate assessment device, in which the respiratory index, changes in the respiratory index, the patient's respiratory status, and / or any changes in respiratory support can be determined. Information about changes in respiratory support can then be transmitted back to the clinician and / or the respiratory support device to take appropriate action. Additionally or alternatively, the information can be transmitted to a physician server 100 or a remote server. For example, the clinician can access the information via a web browser / web server. The assessment device can be a server, a respiratory device, a mobile device, and / or any other assessment device. Wired and / or wireless communication can exist between the respiratory support device and clinician devices such as smartphones.

[0528] The respiratory support device may include a controller configured to control a blower to provide bilevel pressure therapy. The respiratory support device may be coupled to a sealed interface, such as a full-face mask. Optionally, a NIV tube with lower flow resistance than a high-flow-rate tube (as shown in the figure) may be coupled. The user can manually select an NIV mode (e.g., bilevel pressure therapy or CPAP therapy), and the controller is configured to operate in the selected mode. Alternatively, the respiratory support device may be configured to detect the connection of the sealed interface and / or the connection of the NIV tube and automatically adjust the control accordingly.

[0529] In a further alternative, patients can be physically connected to a suitable pressure support device, such as an NIV device.

[0530] Generally, there are various embodiments of the respiratory index and how to use changes in the respiratory index to assess changes in a patient's respiratory status and / or respiratory support; and any of these embodiments can be used in conjunction with any of the various embodiments of respiratory support devices and (where applicable) a separate assessment device to perform:

[0531] Evaluation phase, and optional

[0532] Respiratory support phase (information about respiratory support and / or changes to respiratory support)

[0533] 2. Evaluation Methods

[0534] 2.1 Overview of Evaluation Methods

[0535] refer to Figure 1 Changes in the respiratory index can be used to determine appropriate respiratory support actions. As a transitional step, changes in the respiratory index can be used to assess the patient's respiratory status, but this is not mandatory.

[0536] The respiratory index can be determined by / is a function of the following: one or more lung mechanics parameters (such as respiratory rate, expiratory time, minute ventilation) and one or more oxygenation parameters (such as SpO2, FiO2, FdO2, O2 fraction).

[0537] The respiratory index can be a unitless number f(x) that is a function of one or more patient parameters, namely:

[0538] • Physiological parameters (which may include respiratory parameters), and

[0539] • Breathing device parameters (which may include operating parameters)

[0540] Physiological parameters may include lung mechanics parameters and / or oxygenation parameters.

[0541] The respiratory index can be calculated based on sensor input and / or user input that provides the above data. As an example, the respiratory index is based on respiratory rate (RR) and FiO2 (the concentration of oxygen delivered to the patient). This index is preferably related to 1 / RR and / or 1 / FiO2. In one example, the index = A / B (RR*FiO2), where A and B can be constants or other values.

[0542] An example of a respiratory index is the ROX index.

[0543] The ROX exponent is expressed as a function.

[0544] ROX(x) = f(FiO2, SpO2, RR)

[0545] And the calculation is as follows:

[0546] ROX = (SpO2 / FiO2) / RR

[0547] in:

[0548] SpO2 is the set oxygen saturation (%) in a patient's blood, or alternatively, the actual oxygen saturation (%) in a patient's blood.

[0549] FiO2 is the fraction of oxygen inhaled by the patient (%) (FdO2 can be used as a substitute), and

[0550] Respiratory rate is the rate of breathing measured in breaths per minute.

[0551] The above are the "input parameters", which are received or pre-configured by the sensor and / or the user via the I / O interface, step 10.

[0552] For example, SpO2 is received from a sensor (such as a pulse oximeter) or from the device's SpO2 setpoint. For example, the respiratory rate is received from a sensor as described above. For example, FiO2 can be inferred from the oxygen concentration (e.g., FdO2) provided to the patient by the device, measured by a sensor. These are merely examples. More details on how information is obtained are described regarding device embodiments.

[0553] In the use of the ROX index, in a preferred embodiment, the ROX index threshold for respiratory failure is 4.88, which has been determined by experimental data. In this case, if the ROX index is greater than or equal to about 4.88, the patient is considered to have a low risk of respiratory failure. However, if the ROX index is lower than about 4.88, the patient is considered to have a high risk of respiratory failure. It should be noted that clinically insignificant deviations from the threshold of 4.88 are possible and should not be excluded from the scope of this embodiment. It is also clear that the threshold can be different values ​​where appropriate.

[0554] However, a single time instance of the ROX index relative to a threshold may not be sufficient to provide information to determine whether the current treatment setup is effective for the patient. The trend of the ROX index (or more generally the respiratory index) over time and / or its relationship with the threshold may also be useful.

[0555] In step 20 of the assessment phase, a respiratory index (e.g., the ROX index) can be calculated (step 21). The change in the respiratory index over time can then be determined and used to determine whether high-flow respiratory support has been successful and whether changes are necessary (step 22). For the ROX index, the value begins to decrease if FiO2 and respiratory rate increase. Increases in FiO2 and respiratory rate indicate a deterioration in the patient's condition. Continuous monitoring of the ROX index (causing changes in the ROX index) is helpful when the patient's condition is unstable.

[0556] As an example, refer to Figure 1 The device receives input parameters (step 10) and (e.g., by calculation) determines a respiratory index (e.g., the ROX index) and the change of the respiratory index over time (step 21). Optionally, the patient's respiratory status is then assessed based on the change of the respiratory index over time. This can be done by determining the relationship between the change of the respiratory index over time and other information. For example, the change of the respiratory index over time can be compared to a threshold to determine whether the patient's respiratory status is "respiratory distress" or a more advanced level of distress such as "severe" (e.g., the patient is at high risk of respiratory failure).

[0557] Based on the patient's respiratory status (or directly based on the ROX index or other respiratory indices changing over time), an assessment of changes in respiratory support can optionally be determined (step 22). (Because the patient's respiratory status can be assessed based on the relationship between the respiratory index changing over time and a threshold, the assessment of changes in respiratory support (steps 22, 23) can alternatively be considered as being determined based on the relationship between the respiratory index changing over time and a threshold.) Using the ROX index and a threshold over time, changes in respiratory support (step 23) can be an escalation or a de-escalation of respiratory support. Details of changes in respiratory support (escalation, de-escalation, or other aspects) are described later with respect to device embodiments.

[0558] The examples above involve using the respiratory index to determine a patient's respiratory status. As mentioned earlier, alternatively, patient parameters (which can be components of the respiratory index) can be used for assessment. Therefore, more generally, one or more respiratory parameters can replace and / or be used in conjunction with the respiratory index to assess a patient's condition.

[0559] In many cases, clinicians will assess respiratory status based on information displayed on an assessment device. Various combinations of graphical and numerical representations of parameters and respiratory indices allow clinicians to obtain indications of the respiratory status, particularly its direction and the possible interventions that may be needed.

[0560] In the context of clinician assessments, the display of information can assist clinicians in terms of providing information in a way that is viewable and accessible.

[0561] Generally, assessments can be conducted by displaying various combinations of respiratory indices, variability indicators, patient parameters, and / or thresholds graphically and / or numerically to provide support information for clinicians in making decisions. Examples will be described later in this article.

[0562] Any one or more of the following parameters can be displayed numerically and / or graphically in any suitable combination to assist clinicians in assessment. Any particular parameter on its own may not guarantee action, but may indicate the need for action when considered in conjunction with other information. For example, the ROX index on its own may not be of any concern, but a deterioration in the ROX index over time may be. Alternatively, even a deterioration in the ROX index over time may not be of concern unless it is accompanied by related changes in other parameters such as respiratory rate, SpO2, or FiO2. Furthermore, absolute or relative changes in any of the above may not be of any concern unless they exceed a certain threshold. By providing access to various combinations of this information, clinicians gain a richer set of information to assess respiratory status.

[0563] Some of the following parameters (evaluation information, evaluation criteria, and / or relationship information) can be used individually or in combination:

[0564] • Respiratory index

[0565] • Changes in respiratory index over time

[0566] • Patient parameters (e.g., respiratory rate, SpO2, FiO2)

[0567] • Changes in patient parameters over time

[0568] • Indicators of change (such as slope, vector, magnitude, difference, angle) of any parameter in this document over time or another metric.

[0569] • Respiratory index threshold

[0570] • Threshold for change indicators.

[0571] • These parameters can be displayed graphically (i.e., as 2D and / or 3D charts / graphs or other suitable visual output) or numerically, for example as some of the following:

[0572] • Relationship between respiratory index and time

[0573] • Changes in respiratory index over time

[0574] • Relationship between patient parameters and time

[0575] • Relationship between changes in patient parameters and time

[0576] • Respiratory index threshold

[0577] • Threshold for change indicators.

[0578] • User input can be received to manipulate graphical information to gain further insights. For example, this could include:

[0579] • Zoom in and / or move the image

[0580] • Delve deeper into the plot to obtain additional graphs about the baseline parameters; for example, select a graph of respiratory index versus time, and then obtain a graph of patient parameters versus time.

[0581] The above is not restrictive, and various examples will be described later.

[0582] The following are possible examples, but they should not be regarded as limitations on the more general embodiments described above.

[0583] 2.2 Example 1 – Assessment Method – Trend of Respiratory Index

[0584] In this embodiment, reference Figure 1 The respiratory index is determined over time, and changes in the respiratory index over time are used to assess changes in respiratory status and / or respiratory support.

[0585] The respiratory index can be any index as previously described, such as a function of the following:

[0586] • A parameter representing lung mechanics and a parameter representing oxygen exchange, or

[0587] • Respiratory rate, such as RI (RR), or,

[0588] • A function of respiratory rate and FiO2, such as RI (FiO2, RR), or

[0589] • A function of respiratory rate, FiO2, and SpO2, such as RI(SpO2,FiO2,RR).

[0590] Assess the change in respiratory index over time (step 20). Optionally, assess the patient's respiratory status, and, for example, actually use the trend of change in the respiratory index to indicate the patient's respiratory status. Reference Figure 2 or Figure 5 If the respiratory status tends towards a better value (e.g., tending towards, crossing, or exceeding a threshold) and / or tends towards a better value at or above the threshold rate, an assessment of good or improving respiratory status can be made. Conversely, if the respiratory status tends towards a worse value (e.g., moving away from, crossing, or exceeding a threshold in another direction) and / or tends towards a worse value at or above the threshold rate, an assessment of poor or deteriorating respiratory status can be made. Decisions regarding any changes in respiratory support can then be made. It should be noted that a definitive determination of respiratory status is not actually necessary. In steps 22 and 23, decisions regarding changes in respiratory support can be made based on changes in the respiratory index over time without explicitly determining the respiratory status. However, when a specific respiratory index or a change in the respiratory index (e.g., a trend) is observed, the relationship between the respiratory index and respiratory status can be used to pre-determine appropriate respiratory support actions.

[0591] A trend can be characterized in any suitable way as a parameter representing the change in the respiratory index (trend). This characterizes the trend / change in both magnitude and direction. As an example, a trend can take the form of a vector showing the change in the respiratory index (e.g., over time, but also with respect to another suitable parameter). Alternatively, information about thresholds indicating the crossover between lower and higher risk values ​​of the respiratory index can be used to assess the trend. For example, this vector can be obtained from a graph of the derivative of the respiratory index with respect to time, which gives the slope and thus the direction and magnitude of the change. What may be important is not only the direction of change, but also the magnitude indicating how quickly the change is occurring (i.e., the rate of change). The acceleration of change can be observed using the second derivative with respect to time. The second derivative can be displayed numerically and / or graphically.

[0592] Furthermore, the change of trend over time can also be considered. For example, assess the change of the respiratory index's derivative with respect to time, and optionally assess the second derivative of the respiratory index with time (or some other measure of slope / trend change). The first derivative is the trend, while the second derivative is the change of the trend over time. The second derivative of the respiratory index with respect to time can be assessed based on information about the slope and / or magnitude relationship. It is not necessary to actually obtain the derivative with respect to time, and regardless of how it is obtained, its change over time must be considered.

[0593] The change of the respiratory index over time includes determining the trend of the respiratory index. Furthermore, a trend can include multiple trends, each of which changes over time. Each trend becomes an instantaneous trend, specifying the trend of the respiratory index (as a function of time) at that point in time, and determining the trend can include determining multiple instantaneous trends over time. Each trend or instantaneous trend can be represented by a trend parameter, which includes a magnitude (which itself indicates the rate of change of the respiratory index over time) and a direction (of change), and optionally, can be in the following forms:

[0594] Vector, or

[0595] Slope (and optional ground value).

[0596] Figure 2 A graph showing the general respiratory index (GRI) versus time, as well as GRI thresholds, is provided. A GRI above the threshold indicates good respiratory condition (normal breathing, or only mild distress and / or low risk of respiratory failure), while a GRI below the threshold indicates poor respiratory condition (e.g., worsening breathing, respiratory distress, and / or high risk of respiratory failure).

[0597] refer to Figure 2As can be seen, the patient starts from a low respiratory index ("A"), which in itself indicates respiratory distress and a high risk of respiratory failure. However, referring to section "A" of the graph, the slope and vector direction (trend parameter) of the graph, as well as the direction of the graph, generally show that the respiratory index tends to rise towards the threshold, meaning the patient's condition is improving. Therefore, in this situation, patients receiving escalated respiratory support (because they are in a high-risk respiratory condition) can be weaned off and de-escalated more quickly, or clinicians can at least prepare to de-escalate respiratory support even if the patient remains in a high-risk respiratory condition. Furthermore, even if a patient is below the threshold, clinicians can decide not to escalate respiratory support if the patient is not receiving escalated respiratory support, based on the patient's tendency to approach the threshold (i.e., the respiratory condition is improving).

[0598] Conversely, referring to Part B of the graph, the slope and vector direction of the graph, as well as the direction of the graph, generally indicate that the respiratory index tends to decrease towards the threshold, meaning the patient is deteriorating. Therefore, in this situation, patients receiving de-escalated respiratory support (because they are in a low-risk patient condition) can be escalated to higher-risk respiratory support more quickly, or clinicians can at least prepare for escalation (even if the patient remains in a low-risk respiratory condition). Furthermore, even if a patient is above the threshold when receiving escalated respiratory support, clinicians can decide not to de-escalate based on the patient's tendency to decrease towards the threshold.

[0599] Various other trends and thresholds can be used in this analysis to assess a patient's respiratory status and whether respiratory support needs to be changed. Using trends provides a better level of information, including predictive information to help respond to respiratory support before it is actually needed and to provide some indication of appropriate changes.

[0600] Information related to respiratory index, changes in respiratory index over time, respiratory status, and / or changes in respiratory support can be transmitted appropriately via the I / O interface, enabling clinicians to assess and determine the required respiratory support. Information can also be transmitted as needed to devices, respiratory support systems, and / or servers, such as server 100.

[0601] 2.3 Example 2 – Evaluation Method – ROX Index Trend

[0602] refer to Figure 1 , Figure 4 , Figure 5 In a possible embodiment using the respiratory index over time, the change of the ROX index over time is used to assess the patient's respiratory status.

[0603] The ROX index is determined as previously described, for example by the following calculation.

[0604] ROX = (SpO2 / fiO2) / RR

[0605] As mentioned earlier, the ROX index can be calculated and used to determine whether respiratory support is successful.

[0606] The table below demonstrates the advantages of this method over the single-valued method.

[0607]

[0608] Table 1

[0609] For example, two patients begin NHF treatment, and both have a ROX value of 4.0. Since this is only the start of treatment, ROX values ​​can be monitored to observe whether the index improves. During the first 6 hours, the first patient's respiratory rate decreased and FiO2 decreased, while the second patient's respiratory rate increased and FiO2 increased. As a result, patient 1's ROX value at 6 hours was 6.0, while patient 2's was 3.0. Patient 1 has a high probability of successful NHF treatment and can maintain NHF. However, patient 2 shows a declining trend and a lower ROX; therefore, escalation of care should be considered.

[0610] At the outset, both Patient 1 and Patient 2 had a ROX index of 4.0. This index is below 4.88, thus indicating a risk of respiratory failure. In both cases, a single ROX index assessment would suggest a high risk of respiratory failure and the need for escalation of respiratory support. However, it is evident that Patient 1 actually improved shortly afterward—the ROX index increased to 5.0, 6.0, and 7.0—far above the threshold of 4.88. Therefore, any escalation of respiratory support would have been premature and potentially posed unnecessary risks to the patient's health without any benefit. Conversely, Patient 2's condition worsened, with their ROX index dropping to 3.5, 3.0, and then progressing to respiratory failure. ROX values ​​begin to decline when FiO2 and respiratory rate increase. Increased FiO2 and respiratory rate indicate a worsening of the patient's condition. Continuous monitoring of the ROX index is helpful when a patient's condition is unstable. Clearly, escalation of respiratory support is reasonable in this situation. A single ROX index assessment cannot reflect this dynamic situation.

[0611] Therefore, the change of the ROX index over time (trend parameter) can be determined, and the patient's respiratory status can be assessed based on the change of the ROX index over time, preferably relative to a threshold, and thereby the required changes in respiratory support can be assessed, rather than comparing a single ROX index to a threshold.

[0612] For example, changes in the ROX index over time can indicate a trend of improvement in the ROX index, which may lead to a deterioration in respiratory support; or alternatively, a deterioration, which may lead to an escalation in respiratory support.

[0613] This can be referenced. Figure 4 and Figure 5 To demonstrate, these two graphs show the relationship between ROX index and time and respiratory rate and FiO2 for each of two patients—Patient 1 (40) and Patient 2 (41). Each graph shows a threshold of 4.88 associated with the ROX index, which depicts the respiratory status of patients indicating a high risk of respiratory failure versus those indicating a low risk of respiratory failure. ROX (or other respiratory index) assessments are also referenced. Figure 1 To demonstrate, this diagram shows a flowchart of the evaluation method.

[0614] SpO2, FiO2, and respiratory rate are obtained in a conventional manner, such as from sensors, and the ROX index is calculated from them, for example, in the controller. As previously mentioned, the apparatus used to perform the evaluation method will be described in more detail below. The ROX index is calculated over time. It can be calculated continuously or periodically in a suitable manner, and the value is stored by the controller.

[0615] Furthermore, the variation of the ROX index over time should be determined in an appropriate manner. This can be done, for example, by using trend parameters in vector form that illustrate the variation of the ROX index over time, as referenced. Figure 4 Alternatively, this can be done by plotting the change in respiratory rate relative to FiO2 at different time points, such as... Figure 5 As shown, both methods provide a measure of the magnitude and direction of the change. Figure 4 The metric is given in the form of slope, and Figure 5 This metric is given in vector form. Note that these graphs may be available on mobile devices and / or breathing devices, as described in the following examples.

[0616] Furthermore, the change of trend over time can also be considered. For example, the derivative of the respiratory index with respect to time can be assessed over time, and optionally, the second derivative of the respiratory index with time can be assessed. The first derivative is the trend, while the second derivative is the change of the trend over time. The second derivative of the respiratory index with respect to time can be assessed based on information about the slope and / or magnitude.

[0617] For example, the trend may include multiple instantaneous trends, and determining the trend may include determining multiple instantaneous trends over time. Each trend or instantaneous trend may be represented as, for example, a vector including magnitude and direction. Instantaneous trend parameters provide the trend as it updates over time. Figure 5The vectors of patient 1 (40) and patient 2 (41) at different times are shown, and these vectors are taken from the data in the table above.

[0618] Alternatively, any other suitable depiction or characterization of the ROX index can be made, and these two graphs are merely examples. These graphs and Figure 5 and Figure 6 For illustrative purposes only, to demonstrate the concept. The controller may not need to actually determine and / or display these graphs as described above. Instead, the same information can be obtained for evaluation by processing the ROX index values ​​appropriately.

[0619] Information related to the ROX index, changes in the ROX index over time, respiratory status, and / or changes in respiratory support can be transmitted (and / or stored) appropriately via the I / O interface to enable clinicians to assess and determine the required respiratory support. Information can also be transmitted as needed, for example via wired or wired transmission (including NFC), to devices, respiratory support devices, and / or server 100.

[0620] 3. Respiratory support devices and control methods

[0621] The respiratory index (and optionally respiratory status) assessment methods described in the embodiments herein can be used to determine how best to provide respiratory support. In a preferred embodiment, respiratory support takes the form of high-flow nasal / tracheal respiratory support using an appropriate device. Therefore, this embodiment also relates to a method for providing and modifying respiratory support based on a respiratory status assessment method, and a respiratory device for providing respiratory support, wherein the respiratory support is provided based on the assessment method.

[0622] Based on the assessment phase, one or more of the following changes in respiratory support may occur. The changes in respiratory support mentioned in this article can be implemented by using different respiratory support devices.

[0623] These can generally be categorized into upgraded and downgraded uses that provide respiratory support.

[0624] upgrade:

[0625] • Continue high-flow respiratory support, but at a higher or lower level. For example, increase or decrease the flow rate, O2 concentration, humidification, flow oscillation, and / or other parameters.

[0626] • The patient was transferred to more invasive respiratory support, such as:

[0627] oNIV stress breathing support

[0628] o Respiratory support via intubation (invasive) ventilator

[0629] Relegation:

[0630] • While in use, remove invasive respiratory support and return to basic respiratory support (e.g., NIV respiratory support or high-flow nasal transfusion), or

[0631] • If in use, remove NIV respiratory support and return to basic respiratory support (e.g., high-flow nasal cannula), or

[0632] • Degrade the nasal high-flow rate when in use.

[0633] Upgrades and / or downgrades can be triggered automatically and / or via messages, alerts, or other indicators provided to clinicians that indicate changes in respiratory support should be made based on assessments of respiratory indices that indicate a patient’s condition is improving or deteriorating (e.g., entering or leaving respiratory distress and / or respiratory failure).

[0634] In one example, the flow rate is changed based on or relative to changes or trends in the respiratory index.

[0635] When a respiratory device controls changes in respiratory support, the device can receive instructions or information (e.g., respiratory index, respiratory status, trend parameters, etc.) from the assessment device to make changes, or determine the necessary changes and then make them. Similarly, when a clinician controls changes in respiratory support, the clinician can receive instructions or information (e.g., respiratory index, respiratory status, trend parameters, etc.) from the assessment device to make changes, or determine the necessary changes based on that information and then make them.

[0636] refer to Figure 6 High-flow therapeutic respiratory support devices that can be used to provide respiratory support based on assessment and / or to implement assessment methods will now be described. In cases where escalation or de-escalation involves changing the high-flow respiratory device, this can be done manually by the clinician and / or the device can be configured to make changes automatically. In cases where escalation requires mechanical ventilation or NIV pressure respiratory support, the clinician will use an appropriate device to provide such escalation.

[0637] Figure 6 A respiratory support device 10 for providing high-flow respiratory support to a patient is shown. The device is configured to deliver a device gas flow comprising air and an auxiliary gas, such as a specific fraction of oxygen. The device 10 can be integrated or based on an arrangement of individual components. Figure 6The device is shown in a general outline using a dashed box. In some configurations, the device may be arranged with modular components. Therefore, the device may be referred to as a "system," but these terms are used interchangeably without limitation. Hereinafter, it will be referred to as a device, but this should not be considered limiting. The device is shown as a nasal high-flow breathing device 10, but it can be transformed into a tracheal high-flow breathing device with a tracheal user interface.

[0638] The device includes a flow source 50 for providing a high flow rate of gas 31 (such as oxygen or air, or a mixture of air and oxygen, and / or one or more other gases). Alternatively, the device may have a connection for coupling to the flow source. Thus, the flow source may be considered to be part of or separate from the device, depending on the context, or even a part of the flow source may be part of the device and a part of the flow source may be outside the device.

[0639] The flow source can be an in-wall oxygen source, an oxygen tank 50A, other gas tanks, and / or a high-flow treatment device with a blower / flow generator 50B. Figure 6A flow source 50 is shown, which has a flow generator 50B, an optional air inlet 50C, and is optionally connected to an O2 source (such as a canister or O2 generator) 50A via a shut-off valve and / or regulator and / or other gas flow control element 50D, but this is only an option. The flow source inlet may be referred to as a supplemental gas inlet. The description herein may refer to any embodiment. The flow source may be one of the flow generator, O2 source, air source, or a combination thereof as described above. The flow source 50 is shown as part of the device 10, but in the case of an external oxygen canister or in-wall source, the flow source may be considered a separate component, in which case the device has a connection port for connecting to such a flow source. The flow source provides a (preferably high) flow rate of gas that can be delivered to a patient via a delivery conduit and a patient interface 51. Depending on the end use, the patient interface 51 may be an unsealed (also referred to as “non-sealed”) interface (e.g., when used for high-flow therapy) (e.g., a nasal interface (cannula)) or a sealed interface (e.g., when used for CPAP) (e.g., a nasal mask, full face mask, or nasal pillow). The device can also be used with a high-flow endotracheal interface that reaches the patient's trachea. Patient interface 51 is preferably an unsealed patient interface, which will, for example, help prevent barotrauma (e.g., tissue damage to the lungs or other organs of the respiratory apparatus due to pressure differences relative to the atmosphere). The patient interface can be a nasal interface (intubation) with a manifold and a nose fork, and / or a face mask, and / or a nasal pillow mask, and / or a nasal mask, and / or a tracheostomy interface, or any other suitable type of patient interface. The flow source can provide therapeutic gas flow rates, for example, between about 0.5 liters / minute and about 375 liters / minute, or any range within that range, or even within a range with higher or lower limits. Possible flow ranges are described in more detail in the terminology definition section above.

[0640] The flow rate may include a therapeutic flow rate component, wherein the therapeutic flow rate is about 375 liters / minute to about 0 liters / minute, or about 150 liters / minute to about 0 liters / minute, or preferably about 120 liters / minute to about 15 liters / minute, or more preferably about 90 liters / minute to about 30 liters / minute.

[0641] Optionally, a humidifier 52 may be positioned between the flow source 50 and the patient to provide humidification of the delivered gas. This humidifier may include, for example, a heater plate, an area for housing a humidifier chamber (bucket), and a humidifier compartment for holding water. This may be a humidifier integrated with the flow source 10 to form an integrated device 59 (see dashed line), or a separate humidifier that may be attached to the flow source 10. Alternatively, the humidifier 52 may be a stand-alone humidifier with a chamber and a base, wherein the humidifier is coupled to the flow source 10 via a conduit or other suitable means. One or more sensors 53A, 53B, 53C, 53D (such as flow rate, oxygen fraction or other gas fraction, total or partial pressure, humidity, temperature, or other sensors) may be placed throughout the device and / or at or near the patient 16. Alternatively or additionally, sensors capable of deriving such parameters may be used. Alternatively or alternatively, sensors 53A-53D may be one or more physiological sensors for sensing a patient's physiological parameters, such as heart rate, oxygen saturation (e.g., pulse oximeter sensor 54E), partial pressure of oxygen in the blood, respiratory rate, FiO2, and partial pressure of O2 and / or CO2 in the blood. Alternatively or additionally, sensors capable of deriving such parameters may be used. Other patient sensors may include EEG sensors, a trunk band for detecting respiration, and any other suitable sensors. Sensors may be considered part of or separate from the device, depending on their location. For example, and not limitingly, physiological sensors may be considered separate from the device, while sensors for measuring device parameters may be considered part of the device. In some configurations, a humidifier may be optional, or may be preferred due to the advantage of humidifying gas in helping to maintain airway conditions. Humidification is preferably used in conjunction with a high-flow-rate gas stream to improve patient comfort, compliance, support, and / or safety. One or more of these sensors may be part of the device or may be external to the device, wherein the device has inputs for any external sensors. Sensors may be non-invasive.

[0642] In some configurations, at least one ultrasonic sensor is present. This is advantageous because it is a fast-acting sensor that provides a rapid reading of O2 for either FiO2 or FdO2. Due to its fast response, the ultrasonic sensor allows for better and more accurate control of the O2 fraction.

[0643] In some configurations, the SpO2 sensor can be wireless.

[0644] The sensor output is sent to the controller to assist in controlling the device, including changing the gas flow and / or oxygen fraction. This allows for adjustments to the device's use based on evaluation. The controller is coupled to the flow source, humidifier, and sensors. It controls these and other aspects of the device, as described below. The controller can operate the flow source to provide the delivered gas flow. The controller can also operate the gas flow modulators (including the flow source) based on feedback from the sensors or optionally without feedback (e.g., using default settings) to control the flow rate, pressure, volume, O2 fraction, and / or other parameters of the gas supplied by the flow source. The controller can also control any other suitable parameters of the flow source to meet or increase oxygenation requirements and / or CO2 removal. Controller 19 can also control the humidifier 52 based on feedback from sensors 53A-53D, 14. Using the input from the sensors, the controller can determine oxygenation requirements and provide information to medical professionals (who can control components of the respiratory device to provide desired treatment, such as flow rate, O2 fraction, humidity, etc.) and / or control the parameters of the flow source, the gas flow modulators (multiple) and / or the humidifier as needed. Alternatively, embodiments can be provided as a stand-alone monitoring device, independent of the respiratory device that provides information to a medical professional and / or communicates with and controls components of that respiratory device to provide the desired treatment. The medical professional can then control the respiratory device to provide the desired treatment. Therefore, the controller is not always able to determine oxygenation requirements and control the device parameters.

[0645] The controller 19 is also configured to operate the apparatus such that the gas flow in the apparatus has a flow rate that provides the flow rate described above. The controller can also operate the flow source to control the flow rate, pressure, volume, and / or other parameters of the gas supplied by the flow source based on feedback from sensors or optionally without feedback (e.g., using default settings). The controller can also control any other suitable parameters of the flow source to meet oxygenation requirements.

[0646] Controller 19 is also configured to operate the apparatus such that the apparatus gas flow has a gas ratio (e.g., O2 fraction or other gas fraction) that provides the gas ratios (e.g., gas fraction and / or gas partial pressure) as described above. The controller can do this with any suitable means, such as controlling a proportional valve coupled to the O2 source 50A or any other means previously described. In one embodiment, a single proportional valve is used before the impeller, which controls the O2 fraction entering the impeller inlet along with ambient air, and the impeller controls the flow rate. Controller 19 can control the proportional valve to operate as needed to achieve the gas ratios as described herein.

[0647] Input / output interfaces 54 (such as displays and / or input devices) are provided. These I / O interfaces are used to receive information from users (e.g., clinicians or patients) that can be used to determine oxygenation requirements. The I / O interfaces may include, for example, displays and input devices such as buttons, touchscreens, etc. The screen may be detachable. It can display numerical and / or graphical information (such as 2D / 3D charts).

[0648] The controller can also be configured to determine and implement the assessment methods as previously described based on inputs from, for example, sensors (from the device itself and / or the patient) and other information (such as pre-configured information and / or information input via the I / O interface).

[0649] The nasal high-flow respiratory support device is controlled in a conventional manner known to those skilled in the art to provide flow rate and / or control oxygen fraction to the patient, wherein other operating parameters are provided to provide respiratory support.

[0650] Nasal high-flow nasal cannula respiratory support devices are configured to attempt to control peripheral arterial oxygenated hemoglobin to a predetermined concentration, i.e., 95% SpO2. Typically, SpO2 in patients with hypoxic respiratory failure is controlled at 92%–96%. In patients with hypercapnia, SpO2 is typically controlled at 88%–92%. The NHF device is configured to control the fractional oxygen (FiO2) in an attempt to achieve the set SpO2. The device measures the delivered FiO2 and the patient's respiratory rate (RR).

[0651] Additionally, when it is determined through the evaluation method (according to the above embodiments) that a change in respiratory support is necessary, the nasal high-flow respiratory support device can be operated to change the respiratory support. This will now be described.

[0652] The respiratory support device may have a communication module for communicating with a separate assessment device, where applicable, as described below. The communication module may include a WiFi module, a Bluetooth module, a mobile telecommunications module (such as a GSM module), and / or an NFC communication module. The NFC communication module includes a coil and an associated processor configured to allow NFC communication of data.

[0653] The breathing device has and / or is connected to sensors that provide the following:

[0654] • Physiological parameters (which may include respiratory parameters), and

[0655] • Breathing device parameters (which may include operating parameters)

[0656] To obtain parameters for operating the device (such as temperature, humidity, pressure, and flow sensors) and parameters for determining the respiratory index (such as SpO2, FiO2 (or FdO2) respiratory rate).

[0657] To provide changes in respiratory support, the device can be self-controlled or controlled by a clinician to continue high-flow respiratory support, but at a higher or lower level. This includes, for example, increasing or decreasing flow rate, O2 concentration, humidification, flow oscillation, and / or other parameters. Any of the respiratory support changes described herein can be made in any embodiment associated with the respiratory device.

[0658] 4. Evaluation device

[0659] Embodiments of an apparatus for implementing the evaluation method will now be described.

[0660] 4.1 Example 1 – Evaluation Device Section of Respiratory Support Device

[0661] In one embodiment, the respiratory support device implements any of the assessment methods described herein. Preferably, it uses, for example... Figure 6 The controller of the respiratory support device shown is pre-configured with any data and / or instructions required to perform the method and can receive the required input from sensors, user input, and any other source. This provides the advantage of integrated sensors or sensor inputs, enabling non-invasive monitoring and a single device capable of measuring various parameters and providing / changing the required respiratory support.

[0662] The controller is programmed to calculate the respiratory index using a suitable equation (such as one of the equations above), with the preferred respiratory index being the ROX index. The formula for the respiratory index, which includes the ROX index, has been previously stated.

[0663] Alternative methods for determining the respiratory index can be used, such as lookup tables, databases, etc., that associate input data with appropriate respiratory indices. From this point onward, the device will be described with reference to calculating the ROX index using the above equation, but this should not be considered limiting, and any of the following descriptions can be equally applied to determining another respiratory index based on receiving appropriate input parameters, whether that other respiratory index is calculated or otherwise determined.

[0664] Reference Figure 1 This diagram illustrates the operation of the controller and device. It is similar to the flowchart describing the evaluation method above, but the current flowchart focuses on the actual actions taken by the controller. (Reference) Figure 1 The flowchart shows that the controller receives various physiological and / or operational parameters from appropriate sensors, such as respiratory rate, SpO2, and FiO2.

[0665] Next, the controller uses these input parameters to calculate the ROX index and how the ROX index changes over time. In the case of dynamic evaluation, the ROX index is calculated continuously or periodically to provide a range of values ​​that can be used for trend assessment, such as... Figure 4 As shown. Where appropriate, as described in the above embodiments, the device can determine the change of the respiratory index over time to obtain one or more trend parameters.

[0666] Then, the patient's respiratory status can optionally be assessed by processing the changes and / or trend parameters of the ROX index value over time. Assessing the patient's respiratory status may not be a single step, but rather the result of a series of steps. The result may be an actual determination of the patient's respiratory status, or simply some information related to the patient's respiratory status but not actually determined. However, this information can be used to assess changes in required respiratory support, which is consistent with improving patient outcomes based on the patient's respiratory status (if it is indeed specifically determined). However, for interpretive purposes, the assessment of the patient's respiratory status will be referenced. Alternatively, this information can be obtained by directly processing the changes and / or trend parameters of the ROX index value over time.

[0667] In the case of dynamically assessing a continuously or periodically determined respiratory index, the controller determines a trend parameter (or multiple trend parameters) of the respiratory index over time to provide the magnitude (amount of the rate of change) and direction of change. For example, a time-series measurement is performed, and the trend is determined based on the changes calculated from subsequent index readings. This, along with threshold information, can be used to provide an assessment of respiratory status, such as respiratory distress and / or changes in respiratory status or respiratory distress and / or trends in respiratory status or respiratory distress (e.g., worsening). For example, a high or low risk of respiratory failure can be determined, as previously described.

[0668] Generally, escalation of respiratory support is provided when respiratory distress and / or a worsening of the patient's respiratory condition (e.g., risk of respiratory failure), and de-escalation is provided when respiratory distress and / or an improvement in the respiratory condition (e.g., no respiratory failure). However, these are explained in more detail with reference to the assessment methods described earlier. Actions taken should not be limited to a specific respiratory condition / trend, and these are merely examples. Use actions based on the respiratory index or changes / trends in the respiratory index (which may correspond to a specific respiratory condition or trend).

[0669] If it is determined that an upgrade to respiratory support is needed, the controller can also determine the type of upgrade, which can be one or more of the following:

[0670] • Continue high-flow respiratory support, but at a higher level. For example, increase or decrease the flow rate, O2 concentration, humidification, flow oscillation, and / or other parameters.

[0671] • The patient was moved to more invasive respiratory support, such as:

[0672] oNIV stress breathing support

[0673] o Breathing support via intubation and mechanical ventilation.

[0674] Depending on the required upgrade method, the device can perform one or more of the following:

[0675] • The controller controls the device to upgrade respiratory support, and / or

[0676] • The device transmits information in the form of instructions, status updates, and alarms, thereby advising clinicians to upgrade respiratory support.

[0677] Information can also be provided on the I / O interface (e.g., a display screen) to notify and / or instruct clinicians. For example, it can display... Figure 5 and Figure 6 The screen can be detachable, meaning it can be moved to eye level.

[0678] The controller continuously repeats this method to continuously assess the patient's respiratory index (and / or condition) and accordingly continuously adjusts the operation of the respiratory support device and / or continuously communicates information to the clinician regarding escalation and / or de-escalation of respiratory support.

[0679] The respiratory support device may have a communication module for communicating with a separate assessment device, where applicable, as described below. The communication module may include a WiFi module, a Bluetooth module, a mobile telecommunications module, and / or an NFC communication module. The NFC communication module includes a coil and an associated processor configured to allow NFC communication of data.

[0680] Some additional operational details of the respiratory support device will now be described. The device preferably uses an initiation cycle. The initiation cycle allows the patient to adapt to the high-flow respiratory support provided. Furthermore, a baseline respiratory index value can be established during the initiation cycle. This is the baseline index. The initiation cycle can be between 30 minutes and 3 hours. Preferably, it is between 1 and 2 hours of initial readings and adaptation treatment.

[0681] The device may have an update cycle. The update cycle allows the respiratory support device to measure and calculate new respiratory indices (e.g., ROX index values) and calculate vectors (or other trend parameters). The vector is calculated between two consecutive ROX index value calculations. The update cycle can be between 5 minutes and 30 minutes or any other cycle. The respiratory support device preferably measures respiratory rate and FiO2. These can be transmitted to a mobile device or stored within the device. The sampling cycle can be between 10 seconds and 20 minutes.

[0682] Flow rate changes can be a smooth transition or a continuous variation. Alternatively, flow rate changes can be step changes based on a trend in the respiratory index. As ROX changes, the flow rate undergoes a step change in subsequent update cycles. ROX is calculated after the flow rate changes during the update cycle. The flow rate is altered until a threshold is reached, which is undesirable.

[0683] As a further alternative, respiratory support devices may not automatically change the flow rate. Instructions are issued from the assessment device to the clinician to adjust the flow rate based on the respiratory index. These instructions may include a video or a series of images explaining how and by how much the flow rate should be changed.

[0684] 4.2 Example 2 – Assessment Device Separate from Respiratory Support Device

[0685] refer to Figure 3 In an alternative embodiment, the assessment method is performed in a device 20 separate from the breathing device. The assessment device communicates with the breathing device, sensors, and / or the patient. The assessment device can communicate with, as previously discussed... Figure 1 The assessment is performed in almost the same manner as described for respiratory devices, but with some differences. In such embodiments, separate assessment devices and respiratory support devices and / or sensors can form a respiratory assessment and support system.

[0686] The assessment device has a controller. The controller is programmed to calculate the respiratory index using a suitable equation (such as one of the equations above), preferably the ROX index. The respiratory index equations above can be used, or lookup tables, databases, etc., as described above.

[0687] Reference Figure 1 This diagram illustrates the operation of the controller and device. It is similar to the flowchart describing the evaluation method above, but the current flowchart focuses on the actual actions taken by the controller. (Reference) Figure 1 The flowchart shows that the controller receives various physiological and / or operational parameters from appropriate sensors, such as respiratory rate, SpO2, and FiO2.

[0688] Next, the controller uses these input parameters to calculate the ROX index and how the ROX index changes over time. In the case of dynamic evaluation, the ROX index is calculated continuously or periodically to provide a range of values ​​that can be used for evaluation, such as... Figure 1 As shown. Where appropriate, as described in the above embodiments, the device can determine the change of the respiratory index over time to obtain one or more trend parameters.

[0689] The controller is pre-configured with any data and / or instructions required to perform the method and can receive the required input from the breathing device, sensors, user input and / or any other source.

[0690] Once the controller has the required information, it can proceed as previously referenced. Figure 1 Assess the patient’s respiratory status as described in the methods and / or as described for respiratory support devices.

[0691] Once an assessment of the respiratory status and / or respiratory support response has been made, the device can display appropriate actions and / or communicate with the respiratory device and / or clinician to provide instructions and / or information to the controller, thereby allowing the controller and / or clinician to determine and / or take appropriate changes in respiratory support.

[0692] In one particular non-limiting embodiment, the evaluation device takes the form of a mobile device, such as a smartphone 20, a tablet computer, or other portable and / or mobile communication device, such as... Figure 7 As shown, a mobile device is running an evaluation application on the controller. It has I / O interfaces for presenting information, including alarms.

[0693] The mobile device communicates with the respiratory support device as described above and is programmed with an application to perform assessment methods. In this embodiment, the ROX index is used; however, it will be appreciated that the same technology can be configured to work with any other respiratory index as described above. The mobile communication device includes an application that receives input from a clinician of respiratory rate, FiO2, and SpO2 setpoints (or alternatively, actually measured SpO2), and / or input received from the respiratory support device and / or sensors (e.g., SpO2 sensors or wearable or other sensors as described above) via, for example, Bluetooth™, NFC, or other wireless or wired communication modes. Healthcare providers with portable devices such as smartphones or tablets can additionally or alternatively use an application capable of quickly and securely downloading data via NFC. Input is entered or prompted at regular time intervals. The mobile device calculates the current ROX index value based on the input. Further, the mobile communication device application calculates ROX index trend parameters (e.g., a vector) based on input from the user. Furthermore, the mobile device can calculate multiple such trend parameter vectors that change over time, each trend parameter vector being an instantaneous vector, and each trend parameter vector indicating the trend of the ROX exponent at that point in time. These vectors are displayed on the mobile device's I / O interface, such as... Figure 5 , Figure 7 As shown. This displays vectors at different time points (2 hours, 6 hours, and 12 hours), illustrating the variation in the ROX index.

[0694] Applications / mobile communication devices provide clinicians with assessment tools (diagnostic tools) to quickly determine changes in a patient's condition based on changes in the ROX index and its trends over time. For example... Figure 5 The visual representation of the ROX index vector allows clinicians to make objective decisions about a patient's condition and to escalate or de-escalate respiratory support earlier. If the ROX index vector trend is deteriorating, the earlier the patient is escalated, the better the outcomes are likely to be due to earlier intervention and escalation to mechanical ventilation, leading to a lower mortality rate.

[0695] If the ROX index trend is improving, the earlier the patient is downgraded, the lower the risk of unnecessary escalation of respiratory support.

[0696] As an alternative, the assessment made by the application can be transmitted to the respiratory support device, and the respiratory support device can make appropriate changes to the respiratory support.

[0697] Clinicians can determine the necessary changes in respiratory support. Alternatively, the application can also determine appropriate changes in respiratory support and provide these changes to the respiratory device and / or transmit them to the clinician via a mobile communication device. As previously stated, such changes in respiratory support can be any one or more of the following implemented by the clinician and / or the respiratory device.

[0698] • Continue high-flow respiratory support, but at a higher level. For example, increase or decrease the flow rate, O2 concentration, humidification, flow oscillation, and / or other parameters.

[0699] • The patient was moved to more invasive respiratory support, such as:

[0700] oNIV stress breathing support

[0701] o Breathing support via intubation and mechanical ventilation.

[0702] In one example, the flow rate is changed based on or relative to changes or trends in the respiratory index. For instance, the flow rate change could be proportional to the gradient of the respiratory index change vector.

[0703] Depending on the required upgrade method, the device can perform one or more of the following:

[0704] • The controller controls the breathing device to upgrade respiratory support, and / or

[0705] • The device transmits information in the form of instructions, status updates, and alarms, thereby advising clinicians to upgrade respiratory support.

[0706] For example, it can be assessed that the flow rate delivered to a patient via a ventilator needs to be changed. A mobile communication application is configured to calculate the required change in the flow rate delivered to the patient. The application is configured to calculate the new set flow rate based on the ROX index or a vector of the ROX index (i.e., the trend of change in the ROX index) and / or some other parameters. The application provides the clinician with instructions regarding the new flow rate or the flow rate change required to deviate from the initial set flow rate via the I / O interface of the mobile communication device. Alternatively, this information can be transmitted directly to the ventilator, which also transmits the set flow rate data from the NHF device to the mobile phone via NFC or Bluetooth as part of the interaction between the phone and the device.

[0707] A standalone assessment device can communicate with the respiratory support device via its communication module. The communication interface may include a WiFi module, a Bluetooth module, and an NFC communication module. The NFC communication module includes a coil and an associated processor, configured to allow NFC communication of data.

[0708] In alternative approaches, some assessment methods are performed partly in a separate device and partly in a respiratory support device.

[0709] Alternatively, the graphs and ROX vectors can be calculated in the NHF device and displayed on the NHF device's I / O interface.

[0710] 5. Exemplary embodiments using the ROX index and separate evaluation equipment

[0711] The methods and apparatus embodiments described herein can be combined in any suitable order to provide apparatus and / or systems for providing respiratory assessment and support.

[0712] 5.1 Exemplary Examples of Use Cases

[0713] Reference device Figure 3 , Figure 6 and Figure 7 as well as Figure 1 The flowchart described here is a non-limiting exemplary example.

[0714] It uses a mobile telecommunications device and a nasal high-flow respiratory support device to perform respiratory assessment. The mobile telecommunications device has an application that utilizes changes (trends) in the ROX index (preferably changes / trends over time), and the nasal high-flow respiratory support device is controlled at least in part based on the assessment of the ROX index trend. Alternatively, an NIV device can be used.

[0715] The ROX index is calculated and used to determine the success of high-flow respiratory support (such as nasal or tracheal high-flow respiratory support). Changes in the ROX index over time are used to predict whether a patient's condition is improving or worsening. Specifically, this disclosure relates to determining the time variation of the ROX index value or using one or more vectors of the ROX index over time to determine how the ROX index changes and to provide an indication of whether a patient's condition is worsening or improving. The ROX index value begins to decline if FiO2 and respiratory rate increase. An increase in FiO2 and respiratory rate indicates a worsening of the patient's condition. Continuous monitoring of the ROX index is helpful when the patient's condition is unstable. Nasal high-flow devices are controlled to correct the flow rate provided to the patient and / or control the fractional oxygen. Nasal high-flow respiratory support devices are configured to attempt to control peripheral arterial oxygenated hemoglobin to a predetermined concentration (i.e., 95% SpO2). Typically, SpO2 in patients with hypoxic respiratory failure is controlled at 92%–96%. In patients with hypercapnia, SpO2 is typically controlled at 88%–92%. The NHF device is configured to control the fractional oxygen (FiO2) in an attempt to achieve a set SpO2. The device measures the delivered FiO2 and the patient's respiratory rate (RR).

[0716] Mobile devices. For example, smartphones or tablets 20 used by, for example, clinicians, see [see also:] mobile devices. Figure 7 . Figure 7 Mobile devices have Figure 3 The device includes a controller and I / O interface, and has an I / O interface that functions as a touchscreen, which displays information and allows input, for example, via a touchscreen keyboard. It may also have a speaker for transmitting alarms, prompts, voice messages, etc.

[0717] Mobile devices are configured to communicate wirelessly with respiratory support devices, such as Figure 3 , Figure 6 As shown. This has led to the development of respiratory assessment devices and systems, such as... Figure 3 As shown. As previously described, the mobile device receives the necessary information from the sensor and calculates the current ROX index value based on the input. Further, the mobile communication device application calculates ROX index trend parameters (e.g., vectors) based on input from the user. Furthermore, the mobile device can calculate multiple such trend parameter vectors that change over time, each trend parameter vector being an instantaneous vector, and each trend parameter vector indicating the trend of ROX index change at that point in time. These vectors are displayed on the mobile device's I / O interface, such as... Figure 5 , Figure 7 As shown. In one example, the mobile device is configured to communicate with the NHF device using the NFC protocol. The user can tap the mobile device on the NHF device at a predefined location where the NFC communication module is located. Other communication options are also possible.

[0718] The mobile communication device includes an application configured to be activated when the mobile device is tapped on the NHF device. Tapping the mobile device on the NHF device causes RR data, FiO2 data, and a preset SpO2 setting (or actually measured SpO2) to be transmitted to the mobile device. The mobile device is configured to receive input of respiratory rate, FiO2, and SpO2 settings (or actually measured SpO2) from a clinician, and / or, for example, via Bluetooth. TM Input is received from the respiratory support device and / or sensors (such as an SpO2 sensor) via NFC or other wireless or wired communication modes. Input is entered or prompted at predetermined time intervals. Respiratory rate and FiO2 data can be measured at predetermined time intervals. These time intervals can be between approximately 1 minute and approximately 2 hours, or any other suitable time interval. In one example, measurements are taken every 15 minutes. In another example, measurements are taken every hour or every 2 hours. Alternatively or additionally, the application can receive respiratory rate, FiO2, and SpO2 settings from the clinician via the I / O interface. Input is entered or prompted at predetermined time intervals.

[0719] The application is configured to calculate ROX index values ​​based on data received at each interval. A vector of ROX index values ​​is calculated based on respiratory rate and FiO2 at different time intervals. The sum of ROX index values ​​over a period of time (e.g., 12 hours) is calculated within the mobile application, and a graph is generated. The application also calculates the changes in ROX index and the trend of these changes.

[0720] An increase in respiratory rate and FiO2 indicates a worsening of the patient's condition. A decrease in respiratory rate and FiO2 indicates an improvement in the patient's condition. Furthermore, only a decrease in FiO2 is an indicator of improvement. A decrease in respiratory rate is an indicator of improvement in the patient's condition.

[0721] The application is configured to create Figure 5 The chart shown is displayed to the user on the I / O interface, such as... Figure 7 As shown, the ROX index values ​​were plotted, along with a ROX index vector indicating how the ROX index changes over time. The trend of ROX index change is plotted on a graph showing the relationship between respiratory rate and FiO2.

[0722] Referring to Table 1 above, the original measurement results for Patient 1 and Patient 2 are shown. The application calculates the ROX index and ROX index vector between different ROX index values ​​for each patient at different time intervals, and plots this ROX index and vector on a graph. The graph is shown below. Figure 5 As shown in the diagram. Figure 7The information is presented to clinicians on the screen of their mobile devices to allow for rapid diagnosis.

[0723] The threshold ROX value is plotted as a threshold line, which is 4.88 in this example. This line indicates a successful ROX index—that is, it depicts the difference between a good patient's respiratory condition and a poor patient's respiratory condition. A shift or trend in the ROX index to the upper right indicates a deterioration in the patient's condition. This shift in the ROX index corresponds to a decrease in the ROX index value, which is also associated with a worsening of the patient's condition.

[0724] Figure 7 On the screen of the device Figure 5 The graph shows three vectors for patient 1 (40), each vector showing the instantaneous trend at 2 hours, 6 hours, and 12 hours. Each instantaneous vector shows both magnitude and direction, indicating that the patient is trending (i.e., the vector points) towards a lower ROX value and is therefore improving. Over time, each vector shows that the improving trend is continuing. The first vector shows that the patient is trending towards the ROX threshold of 4.88 (below which the risk of respiratory failure disappears or is at least significantly reduced), and regarding the second 6-hour vector, the patient's respiratory rate is similar, but the ROX index has dropped below the ROX threshold, meaning that the risk of respiratory failure has disappeared or is at least significantly reduced.

[0725] Figure 7 On the screen of the device Figure 5 The graph shows two vectors for patient 2 (41), each vector showing the instantaneous trends at hour 2 and hour 6. Each instantaneous vector shows both magnitude and direction, indicating that the patient is tending (i.e., the vector points) towards a higher ROX value and is therefore deteriorating. Over time, each vector shows that the deteriorating trend is continuing. The first and second vectors show that the patient is tending to move further away from the ROX threshold of 4.88 (below which the risk of respiratory failure disappears or is at least significantly reduced), meaning that the risk of respiratory failure is increasing.

[0726] As in other embodiments, the device can also display other parameters, such as the ROX index, patient breathing status, instructions on what to do (including any changes in respiratory support), and any other information, via the I / O interface. It can also provide audible alarms and / or audible messages conveying the same information. Information can also be transmitted (and / or stored) as needed, for example via wired or wired transmission (including NFC), to the device, respiratory support unit, and / or server 100, etc.

[0727] The application provides clinicians with tools to quickly determine changes in a patient's condition based on variations in the ROX index and its trend over time. A visual representation of the ROX index vector allows clinicians to make objective decisions about a patient's condition and enables earlier escalation. If the ROX index vector trend is deteriorating, earlier escalation is likely to lead to better outcomes due to earlier intervention and escalation to mechanical ventilation, resulting in lower mortality.

[0728] The mobile application is configured to calculate changes in required respiratory support. For example, it can determine the flow rate to be increased for the patient. The application is configured to calculate the new set flow rate based on the ROX index or a vector of the ROX index (i.e., the trend of change in the ROX index). The application provides the patient with information about the new flow rate or the required flow rate change away from the initial set flow rate via the mobile device's I / O interface. The set flow rate data is also transmitted from the NHF device to the mobile phone via NFC or Bluetooth as part of the interaction between the phone and the device.

[0729] Alternatively, the graphs and ROX vectors can be calculated in the NHF device and displayed on the NHF device's I / O interface.

[0730] Clinicians can determine the necessary changes in respiratory support. Alternatively, the application can also determine appropriate changes in respiratory support and provide these changes to the respiratory device and / or transmit them to the clinician via a mobile communication device. As previously stated, such changes in respiratory support can be any one or more of the following implemented by the clinician and / or the respiratory device.

[0731] • Continue high-flow respiratory support, but at a higher level. For example, increase or decrease flow rate, O2 concentration, humidification, flow oscillation, and / or other parameters.

[0732] • The patient was moved to more invasive respiratory support, such as:

[0733] oNIV stress breathing support

[0734] mechanical ventilator support via intubation

[0735] Depending on the required upgrade method, the device can perform one or more of the following:

[0736] • The controller controls the device to upgrade respiratory support, and / or

[0737] • The device transmits information in the form of instructions, status updates, and alarms, thereby advising clinicians to upgrade respiratory support.

[0738] The operation of the respiratory support device is then modified based on the clinician's assessment and / or the equipment's evaluation. The respiratory support device is controlled or controlled itself so that the flow rate improves the respiratory index (and / or respiratory status) based on changes in the respiratory index (i.e., trends, i.e., vectors).

[0739] In one implementation, the embodiment includes a mobile device that receives information from wearable sensors. The information is used as described above, and is transmitted (and / or stored) to clinicians and respiratory support devices, for example via wired or wired transmission (including NFC), to control the devices.

[0740] In one implementation and reference Figure 5 The length of the vector is the magnitude. The magnitude determines how much the ROX vector changes over time. In one example, for an adult, the maximum value on the graph might be approximately (FiO2 1.0; respiratory rate 45) and the minimum value approximately (FiO2 0.21; respiratory rate 15). The distance between these points is the maximum value of the vector. The respiratory device can display the magnitude in the form of bars, dials, colors, %, numbers, etc., starting from the beginning of treatment. If the magnitude is large and the vector moves in the lower left corner (direction), the treatment is very effective. This can be a simple way to display the therapeutic effect of the device. The above relates to calculating the magnitude of the ROX exponential vector, that is, defining a vector with magnitude and direction under instantaneous trends. The magnitude is calculated based on FiO2 and respiratory rate. More specifically, magnitude = (FiO2 1.0; respiratory rate 45) / (FiO2 1.0; respiratory rate 45). 2 + RR 2 The magnitude and direction of the vector are the square root of the respiratory rate. The magnitude and direction define the effectiveness of the treatment. If the magnitude is large and the direction of the vector is correct, the treatment is highly effective. The magnitude relates to the rate at which the patient's health improves. The direction of the ROX vector can be color-coded. For example, if the vector direction indicates that the patient's respiratory condition is improving, the vector can be displayed in the first color. If the vector direction indicates that the patient's respiratory condition is deteriorating, i.e., getting worse, the vector can be displayed in the second color. (Reference) Figure 5 If the vector points downwards and to the left, indicating improved breathing, the vector is displayed in the first color. Alternatively, if the vector points upwards and to the right, indicating worsening breathing, the vector is displayed in the second color. Furthermore, the vector can be displayed such that its length corresponds to its magnitude.

[0741] Clinicians use the presented magnitude and direction information to determine whether to continue high flow or whether the patient needs to be escalated to a different treatment. Alternatively, the mobile device can issue an alarm if the magnitude exceeds a threshold and the direction of the vector indicates a deterioration in the patient's respiratory condition. Alternatively, the respiratory support device's user interface can be configured to display the vector. The respiratory support device is configured to issue an alarm when the magnitude exceeds a threshold and the direction of the vector indicates a deterioration in the patient's respiratory condition. The respiratory support device can be configured to automatically increase the flow rate.

[0742] Some exemplary examples of respiratory support that may be provided based on respiratory index / condition assessment (including, but not limited to, changes in respiratory support) are as follows.

[0743] These can be applied to any of the embodiments described herein.

[0744] • The flow rate supplied to the patient is variable. The flow rate can be increased or decreased by a predetermined amount. Alternatively, the flow rate supplied to the patient can be varied based on the magnitude of the respiratory index vector. Increasing the flow rate helps to reduce the respiratory rate because it increases expiratory resistance. Additional flow can also increase the amount of oxygen (not an increase in FiO2), but a greater flow rate can improve flushing and increase the amount of O2 delivered to the lungs. This can help the patient's oxygenation, thereby increasing the ROX index value.

[0745] • If the respiratory index vector indicates a deterioration in the patient, increase the flow rate (e.g., flow velocity). Increase the flow rate to the limit far from the baseline flow velocity. Further, when the respiratory index vector indicates an improvement in the patient's health, the flow rate can be reduced. The reduction can be far from the baseline until the minimum required flow rate is reached or the flow rate is reduced from the increased flow velocity value.

[0746] • In one example, the respiratory index is the ROX index based on the SpO2 setpoint, FiO2, and respiratory rate. The respiratory support device can also be configured to control the flow rate based on changes in the ROX index.

[0747] • If the ROX index drops below a threshold, such as 4.88, the flow rate can be increased to attempt to provide additional respiratory support.

[0748] • Based on changes in the ROX index, the flow rate can be increased from a base setting to a new flow rate. Alternatively, the rate of change of flow rate can be proportional to the rate of change of the ROX index.

[0749] • In a further example, the NHF device can be configured to control the flow rate provided by the NHF device (and thus the blower motor speed) based on changes in respiratory rate. For example, if the respiratory rate increases, the flow rate can be increased to decrease the respiratory rate, thereby increasing the ROX index. The flow rate change can be proportional to the change in respiratory rate. Alternatively, the flow rate change can be a function of the change in respiratory rate or the respiratory rate itself. If the respiratory rate increases, the flow rate increases to provide additional expiratory pressure (i.e., additional resistance to exhalation), causing the user's respiratory rate to slow down.

[0750] However, if the ROX exponential vector tends toward and exceeds the safety level, i.e., tends toward the threshold indicating deterioration, the NHF device can issue an alert to indicate that the patient needs escalation.

[0751] • The respiratory support device can also adjust the flow rate based on changes in FiO2 demand. If the FiO2 demand to meet the required SpO2 increases, the flow rate can be increased. The increase in flow rate is proportional to the increase in FiO2, or it can be a function of the increase in FiO2. Increasing the flow rate helps to reduce the respiratory rate and increase the total amount of O2 delivered. This can help reduce the demand for FiO2 and keep the ROX vector moving in a safe direction. The flow rate can be increased from a base flow rate of 30 L / min to 10 L / min. If the maximum flow limit is reached, the respiratory support device can issue an alarm.

[0752] In addition to the flow control described above, respiratory support devices can provide synchronized flow during breathing. The flow rate delivered during expiration is lower than the flow rate during inspiration. A pressure sensor, a flow sensor, or a combination thereof is used to detect the patient's respiratory phase. One example is a pressure sensor integrated into the patient interface. Another example is a flow sensor integrated into the patient interface. A further example is a pressure sensor based on a flow sensor (integrated into the respiratory support device) to calculate flow changes or flow resistance.

[0753] • In one example, the inspiratory and expiratory flow rates provided to the patient are predefined by the clinician, or by the patient selecting a "comfort" level. The comfort level defines the difference between the expiratory and inspiratory flow rates. For example, comfort level 1 = a difference of -10 L / min between expiratory and inspiratory flow rates. Comfort level 2 = an expiratory flow rate of -20 L / min, and so on.

[0754] • The flow controller preferably uses feedback control to control the flow rate and switches the flow rate between inspiratory and expiratory flow rate values.

[0755] • If the ROX index (i.e., the respiratory index) trend (vector) tends to indicate a worsening of the patient's condition, then the expiratory flow rate (i.e., the flow rate during expiration) increases and deviates from the predefined expiratory flow rate.

[0756] • Increased flow rate (e.g., increased constant flow rate or increased expiratory flow rate) increases expiratory resistance. Increased expiratory resistance makes it more difficult for the patient to exhale. This reduces the patient's respiratory rate, thereby improving the respiratory index (e.g., ROX index).

[0757] • Further increasing the flow rate delivered during expiration can also help improve upper airway flushing and CO2 clearance from the airways. This can improve patient oxygenation and reduce FiO2 requirements or make oxygenation more efficient. This can help improve the respiratory index or change the respiratory index to indicate improvement in patient health. The increased flow rate also ensures that the delivered flow rate is greater than or equal to the inspiratory requirement, thereby reducing ambient air entrainment. Reduced ambient air entrainment ensures a more consistent FiO2 concentration.

[0758] • The mobile device is configured to determine the flow rate change required to improve the respiratory index provided by the respiratory device and to present instructions on the mobile device's I / O interface to change the flow rate. For example, increasing the flow rate to improve the respiratory index.

[0759] • When the flow rate is altered relative to an exponential change, the O2 valve of the breathing device can be controlled to increase or maintain FiO2.

[0760] • FiO2 in the breathing device can be altered relative to changes in the breathing rate or relative to an index.

[0761] • The mobile device is configured to determine the flow rate change required to improve the respiratory index provided by the high-flow breathing device and to present instructions for changing the flow rate on the mobile device's UI.

[0762] • Increase flow rate to improve respiratory index.

[0763] • The respiratory rate controller is configured to increase the flow rate from the baseline when the trend (or change) of the respiratory index indicates an increase in respiratory deterioration.

[0764] • The controller is configured to reduce the flow rate to the baseline flow rate when the respiratory index indicates a decrease (or improvement) in respiratory deterioration.

[0765] • Optionally, any change in flow rate is proportional to the change in the respiratory index.

[0766] • Optionally, any change in flow rate is a function of the change or magnitude of the respiratory index.

[0767] • The display of the respiratory therapy device shows a vector of respiratory indexes, where the vector indicates changes and trends over a period of time.

[0768] • If NHF increases and respiratory rate decreases while FiO2 does not decrease, this may only indicate a temporary effect of expiratory resistance, and the device should maintain or decrease the NHF rate, for example, by 5 L / min. If both FiO2 and respiratory rate decrease, which is a positive dynamic indication, the NHF can be slowly decreased from 60 L / min to 40–35 L / min to make the treatment more comfortable. Alternatively, in variable NHF, the device may begin to increase the expiratory pressure release.

[0769] In an alternative, no separate evaluation device is used, and the above embodiments are performed entirely on the respiratory support device. Alternatively or additionally, a mobile device can be used as a remote control for controlling the respiratory support device.

[0770] 5.2 Alternative Use Cases

[0771] Figure 8 A to Figure 11E Alternative use cases that can be implemented on the apparatus described in this section or on any other apparatus described within the scope of this specification are shown.

[0772] refer to Figure 8 A to Figure 8 C, considers an example scenario of monitoring the ROX values ​​of three patients from 80A to 80C over time. ROX is used as an example, and the use case can be generalized to any respiratory index.

[0773] The first patient (Patient 1) had 80A at t n The current ROX value at 84A is on the high-risk side (below the threshold) of ROX threshold 82, but the ROX slope is 83A (i.e., ROX changes with time t). n -1 84A to t n The derivative of 85A, or the current data at point t in ROX. n 85A and previous ROX data point 84A t n The slope between -1) is on the low-risk side of the slope threshold (in which case the slope is zero).

[0774] The second patient (Patient 2) has a current ROX value of 84B and a ROX slope of 83B, both on the high-risk side of their respective thresholds. That is, the ROX is below the ROX threshold of 82, and the ROX changes over time t. n -1 84B to t n The derivative of 85B or the current data ROX point t n 85B and previous ROX data point 84B t nThe slope between -1 and -1 is negative, so the trend is worse.

[0775] The third patient (Patient 3) has a current ROX value of t at 80°C. n 84C is on the low-risk side (below the threshold) of 82, but its ROX slope 83C is on the high-risk side of the slope threshold. That is, ROX changes with time t. n -1 84C to t n The derivative of 85C or the current data ROX point t n 85C compared to the previous ROX data point 84C t n The slope between -1 and -1 is negative, so the trend gets worse.

[0776] The ROX (value and slope) for each of these patients, ranging from 80A to 80C, can indicate different health states and may require different responses. For example, the first patient's ROX 85A might indicate they are in a state requiring attention, but their condition has not recently worsened (the physician can use this information to prioritize other patients). The second patient's ROX indicates their health condition is already at high risk but may still deteriorate—they require immediate attention from the physician. The third patient's ROX 85C might indicate their health condition is rapidly deteriorating towards a high-risk state. This indication allows physicians to intervene early and prevent the patient's health condition from actually reaching a high-risk state (i.e., preventing their ROX value from dropping to a high-risk value).

[0777] refer to Figure 9 A, Figure 9 B, considers another example scenario. The current ROX values ​​t for two patients (Patient 1 and Patient 2). n -1 94A and 94B are on the high-risk side of the ROX threshold of 92 (i.e., below the threshold).

[0778] The slope 93A of the first patient (Patient 1 90A) indicates that their ROX value 94A is trending towards a lower risk value 95A (tending towards the threshold). The slope 93B of the second patient (Patient 2 90B) indicates that their ROX value 94B is trending towards a higher risk value 95B. Similarly, the ROX (value and slope) of each of these patients indicates a different health status and may require a different response. The first patient's 90A appears to be improving (better trend / positive 93A), so they could benefit from more treatment time in the same setting. The second patient's 90B appears to be deteriorating further (worse trend / negative 93B), so they may need a change in treatment settings.

[0779] In addition to identifying short-term changes in a patient's health condition, this system can use comparisons with thresholds to identify long-term (i.e., slower) changes in a patient's health condition:

[0780] refer to Figure 10 The ROX value of patient 101, which ranged from 103 to 107, decreased slowly over several days (t). n -4 to t n This is an example scenario. Although such a decline may eventually cause the patient's ROX value to drop below the threshold of 102, this system can be able to identify the decline in the patient's health condition before this occurs. By examining multiple previous ROX value data points from 103 to 107, the system can identify a (slow) decline in the ROX value—even if a single slope, such as 108 (between any two data points, such as 103 to 104), is on the low-risk side of the slope threshold. The system can then respond before the patient's ROX value actually drops below the threshold, thus enabling early (i.e., preemptive) intervention.

[0781] This indicates that what matters is not only the slope / change over time, but also the relative amount of ROX decrease over a period of time.

[0782] An exemplary embodiment is as follows. This method and / or apparatus is capable of determining the respiratory index and / or respiratory status of a patient receiving high-flow or other respiratory support. This provides information about the patient's condition when the patient receives respiratory therapy (e.g., high-flow respiratory support, such as high-flow nasal cannula). This provides information about whether the patient is stable, deteriorating, or improving. This can also indirectly serve as an indicator of the effectiveness of respiratory support. The information can be displayed numerically and / or graphically, for example, as a vector. The information can be, for example:

[0783] • The respiratory index changes over time, similar to the first derivative with respect to time, and / or

[0784] • The trend of the respiratory index over time is similar to the second derivative with respect to time.

[0785] By examining the respiratory index and / or other parameters, and how the respiratory index changes over time, it is possible to assess whether:

[0786] • Changes in breathing support are required, and / or

[0787] • What might this change be?

[0788] Based on this information, a certain action can be taken, for example

[0789] • Changes can be made.

[0790] • Change the instructions / alarms of the therapy, and / or

[0791] • The device automatically attempts to change the treatment.

[0792] Ultimately, if the patient does not improve according to the index (i.e., the reassessment phase), an alert is issued to escalate the treatment.

[0793] 6. Information presented by clinicians during assessment

[0794] As mentioned earlier, in many cases, clinicians will assess respiratory status based on information displayed on assessment devices. Through various combinations of graphical and numerical representations of parameters and respiratory indices, trained clinicians can interpret these to obtain indications of the respiratory status, particularly the direction of the respiratory state and what kind of intervention may be needed.

[0795] Various examples will now be discussed. These are not limiting, but rather provide indications of possible sources of information and how clinicians can use them to assist in assessing respiratory status. Clinician assessments may include assessment criteria that allow clinicians to evaluate respiratory indices, patient parameters, variability indicators, and / or other assessment information to determine a patient's respiratory status. Assessment criteria may include and / or utilize relational information such as thresholds. These assessments can be used in conjunction with any of the embodiments described herein.

[0796] To display assessment information, assessment criteria, relational information, and / or any other information, a user interface 54 can be used on the assessment device (such as a mobile device and / or treatment device) and / or treatment device. Numerical and graphical information can be displayed. Graphical information can be in the form of 2D or 3D graphs / charts. In 3D, optionally, an axis can be a time axis showing the change of assessment information over time. User control allows manipulation of the display. A touchscreen can be used.

[0797] In more general cases, such as Figure 2 As shown, the assessment method and apparatus include displaying the change of the respiratory index over time at each of multiple time points. Clinicians can then review this. A respiratory index threshold can be provided to help determine whether the respiratory condition is trending towards improvement or deterioration. Similarly, the index of change (in this case, a vector with a slope) can indicate a trend.

[0798] refer to Figure 5 This provides further information. In this case, a vector showing changes in the respiratory index is plotted on a graph of respiratory rate versus FiO2. The ROX index threshold of 4.88 is also plotted on the graph. A positive slope over time toward the upper right of the graph (in this case) indicates that the patient's condition is deteriorating. Alternatively, a negative slope over time toward the lower left indicates improvement (even though the ROX index starts in the "at risk" section, it tends to and crosses the threshold into the improvement section).

[0799] In either case, clinicians can monitor changes in the respiratory index over time by referring to thresholds, and Figure 5 In this case, additional in-depth information is also available, which also shows respiratory rate and FiO2. This can complement the process of calculating and comparing various change information with relational information (thresholds, such as ROX thresholds and / or change index thresholds, such as vector slope thresholds). Figure 2 , Figure 4 and Figure 5 The information in the document shows a combination of graphics (e.g., charts and vectors) and numerical information.

[0800] More generally, the information is displayed on an interface on a respiratory device, mobile device, and / or other assessment device, and may include: the relationship between respiratory indices (e.g., the ROX index) and time, displayed graphically and / or numerically; the relationship between one or more components of the respiratory indices (e.g., respiratory rate, SpO2, FiO2, etc.) individually, in combination, and / or optionally, and time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change indicating the variation between two or more respiratory indices and / or their components over time or other aspects.

[0801] In doing so, clinicians can determine a patient’s respiratory status by looking at the following based on changes in respiratory indices over time: the relationship between respiratory indices (e.g., the ROX index) and time, displayed graphically and / or numerically; the relationship between one or more components of respiratory indices (e.g., respiratory rate, SpO2, FiO2, etc.) individually, in combination, and / or optionally, and time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change between two or more respiratory indices and / or their components over time or in other ways.

[0802] To aid in information evaluation, users can interact with and / or manipulate a graphical interface to better utilize the information. This can include apparatus and methods for receiving input (e.g., user input) for modifying the display and for re-displaying information based on the user input, the method comprising one or more of the following: receiving input for displaying one or more components of a respiratory index, and displaying, graphically and / or numerically, the one or more components of the respiratory index (e.g., respiratory rate, SpO2, FiO2, etc.), individually, in combination, and / or optionally, their relationship with time; and / or receiving input to display, zoom, and / or move the display, and displaying or re-displaying zoomed and / or moved versions of: the relationship of a respiratory index (e.g., the ROX index) to time, displayed graphically and / or numerically; one or more components of a respiratory index, individually, in combination, and / or optionally, their relationship to time, displayed graphically and / or numerically; and / or one or more vectors, slopes, angles, magnitudes, differences, and / or other indicators of change indicating the variation between two or more respiratory indices and / or their components over time or other aspects.

[0803] As an example, the patient might be able to click Figure 2 To receive information from Figure 5 The information. Then they can zoom in and / or move. Figure 5 To better view the information.

[0804] Clinicians determine a patient's respiratory status based on changes in the respiratory index over time using any one or a combination of the following:

[0805] Compare one or more respiratory indices and / or changes in respiratory indices to one or more thresholds, see, for example... Figure 2 , Figure 4 , Figure 5 ,

[0806] Compare one or more change indicators with one or more thresholds.

[0807] Compare changes in one or more respiratory indices and / or respiratory indexes with changes in one or more other respiratory indices and / or with one or more other change indicators.

[0808] Compare one or more change indicators with one or more other change indicators and / or one or more respiratory indices and / or changes in respiratory indices.

[0809] Consider one or more:

[0810] Respiratory index,

[0811] Changes in respiratory index over time

[0812] Changes in respiratory index over time, and / or

[0813] Change indicators.

[0814] Figures 11A to 11E Specific non-restrictive examples are shown in the figure.

[0815] Clinicians classify a patient's respiratory status as "at risk but improving" when the ROX index is below a threshold, but the ROX index change indicates a decreasing trend in risk. See also Figure 11A If this is determined, the assessment device can also provide indications, such as initial alerts and display messages indicating that the patient is at risk but is improving.

[0816] Clinicians classify a patient's respiratory condition as "at risk and deteriorating" when: the ROX index is below a threshold, and changes in the ROX index indicate an upward trend in risk. See also Figure 11B If this is determined, the assessment device provides indications, such as alarms and display messages indicating that the patient is at risk and is deteriorating.

[0817] Clinicians classify a patient's respiratory condition as "no risk (or low risk) but deteriorating" in the following situations: the ROX index is above a threshold, but the ROX index change indicator shows an upward trend in risk. See also Figure 11C If this is determined, the assessment device provides indications, such as a quiet alarm, and then a loud alarm if / when the ROX index drops below a threshold.

[0818] Clinicians may assess potential problems in the following situations, even if they determine that a patient's respiratory status has not changed significantly: Even if SpO2 is stable, the respiratory rate shows an upward trend (exceeding a threshold slope or other indicators of change). See [link to relevant documentation]. Figure 11D If confirmed, display the appropriate message on the screen.

[0819] Clinicians will classify a patient's respiratory condition as "worsening" in the following situations:

[0820] The respiratory rate is trending upward (exceeding the threshold slope or other indicators of change) and SpO2 is trending downward. See also Figure 11E If confirmed, activate the appropriate alert.

[0821] Clinicians determine a patient's respiratory status based on the ROX index, which is compared to one or more thresholds. See, for example... Figure 2 .

[0822] Clinicians determine a patient's respiratory status based on the following:

[0823] respiratory rate,

[0824] SpO2, and / or

[0825] FiO2

[0826] This determination is based on one or more thresholds.

[0827] Clinicians determine a patient's respiratory status based on the following changes over time:

[0828] Respiratory index and / or patient parameters, such as respiratory rate, SpO2, and / or FiO2. See also Figure 5 .

[0829] Clinicians determine a patient's respiratory status based on changing indicators, such as the slope, magnitude, and / or angle of the respiratory index values ​​across multiple time points. See also Figure 5 .

[0830] Clinicians determine a patient’s respiratory status based on changing indicators, such as the slope, magnitude, and / or angle between patient parameters (e.g., respiratory rate, SpO2, and / or FiO2) at multiple time points.

[0831] Clinicians determine a patient’s respiratory status based on the length of time required for changes in respiratory index and / or change in variability indicators and / or the magnitude of change within a threshold time.

[0832] Clinicians determine a patient’s respiratory status based on the time required for the respiratory index and / or changes in the respiratory rate to reach a threshold level.

[0833] The evaluation information will be based on information obtained at multiple points in time. These points in time can be consecutive or discrete. Similarly, the display of the evaluation information can be at consecutive points in time and / or on a display. Alternatively, the display of the information can be discontinuous in time and / or on a display. In the case where the information or display is discontinuous in time, the points in time can be less than one second, one second, several seconds, less than one minute, one minute or several minutes, or any point between 1 and 59 minutes, less than one hour, one hour, several hours, or any point between 1 and 24 hours, less than one day, one day or several days. These points in time can be fixed or variable.

[0834] If the respiratory index has increased to a certain threshold, the flow rate can be reduced to the baseline flow rate or a rate reduced based on the rate of change in the respiratory index. For example, the flow rate change can be proportional, or it can be defined by a function that correlates the flow rate change with the respiratory index change. This function can be a decaying function, a logarithmic function, or a hyperbolic function. When clinicians perform respiratory status / index assessments, they can also determine appropriate changes in respiratory support if needed.

[0835] If the device performs a respiratory status / index assessment, it can alert clinicians via messages, warnings, alarms, messages, or other indicators as described herein. This alerts the clinician to the need for a change in respiratory support, but may not actually suggest what the change should be. Clinicians can make changes manually by operating the respiratory support device. Alternatively or additionally, the assessment device can suggest what the change in respiratory support should be. This can be done via any kind of indicator, such as warnings, alarms, messages, etc. Again, clinicians can make changes. Furthermore, the respiratory support device can automatically make the necessary changes.

[0836] Optionally, the respiratory device may include a communication interface configured to transmit information to a mobile device (e.g., a smartphone or tablet) associated with a clinician or healthcare professional and / or to a remote patient monitoring system. The remote patient monitoring system may include one or more servers, client devices, memory units, databases, and / or other components that allow the management of patient information, the generation of patient health reports, and the sending and / or access to alerts to patients and / or clinicians. Changes in respiratory indexes may be transmitted to the mobile device and / or the remote patient monitoring system.

[0837] Respiratory index measurements and changes in the respiratory index can be incorporated into a patient report, which includes measured patient parameters such as SpO2, flow rate, humidity setpoint, and usage time, as well as the respiratory index and changes in respiratory index measurements over time.

[0838] Changes in the respiratory index allow clinicians to assess the effectiveness of the current treatment being administered and also allow them to modify the treatment being provided. In one example, the operating parameters of the respiratory support device (such as prescription settings) can be updated remotely based on changes in the respiratory index.

[0839] 7. Advantages

[0840] One or more of the above embodiments may provide one or more of the following advantages:

[0841] • Visually track respiratory trends to enable clinicians to make decisions regarding respiratory support. For example, examples may show negative trends and / or negative trends exceeding a threshold.

[0842] • Provide alerts to patients that they are heading in the wrong direction so that decisions can be made regarding respiratory support.

[0843] • Device-led decisions based on respiratory trends indicate that a patient may have adverse health effects and requires a specific level or type of respiratory support, including escalation to more invasive methods. The device controller can automatically adjust the level of respiratory support or generate alerts.

[0844] • Enable decisions on escalating respiratory support quickly enough to ensure good outcomes, but not so quickly that escalation may be unnecessarily premature.

[0845] • An automated method for determining changes in a patient's respiratory status and condition based on changes or rates of change in respiratory indices. This provides early warning compared to more time-consuming and / or more invasive diagnostic methods.

[0846] • An automated, minimally invasive method for determining respiratory index and assessing respiratory status.

[0847] • A respiratory support device that serves as an integrated sensing unit and can be used in hospital or home assessment phases.

[0848] • Improve decision-making.

[0849] • If breathing conditions and / or respiratory indexes worsen, escalate respiratory support more quickly.

[0850] • Remote monitoring of patient conditions (e.g., monitoring patients at home) helps manage treatment. These examples can help assess patients who are far from clinicians based on changes in respiratory index.

[0851] • The respiratory device is used as a non-invasive sensor block / device to verify the device. The respiratory index is calculated within the device. Changes in the respiratory index can also be calculated in respiratory support devices or remote patient monitoring devices.

[0852] • Assess the effectiveness of NHF therapy and help determine whether patients in remote settings are likely to develop respiratory failure, and then provide early warnings about this.

[0853] • Knowing where to set the respiratory index threshold (to differentiate between a predicted NHF success and a predicted NHF failure under current treatment conditions) requires empirical data from different patient groups. This is because a threshold that effectively distinguishes predicted success or failure in COPD patients may not be effective in distinguishing predicted success or failure in patients with pneumonia, for example. Using changes in respiratory index values ​​to assess patients overcomes this problem—because a threshold respiratory index value is not required.

[0854] • If clinicians only monitor a patient's respiratory index value (rather than its real-time changes), they may miss potentially problematic changes in the patient's condition. For example, if FiO2 decreases simultaneously, a potentially problematic increase in the patient's respiratory rate may not result in a change in their respiratory index value. A graph showing a patient's respiratory rate relative to their SpO2 divided by their FiO2 will allow clinicians to observe that the patient's respiratory rate is increasing, even if their index value does not increase. Similarly, if such a change in respiratory rate occurs, an alert can be activated based on the slope of one or more vectors connecting data points on such a graph.

Claims

1. A system for assessing a patient receiving respiratory support during a certain period to determine their respiratory status, the system comprising: One or more sensors, or inputs to one or more sensors, for receiving one or more patient parameters for a patient at multiple time points, said one or more patient parameters including at least one respiratory parameter. Controller, the controller is used for: - The ROX index for each time point is determined by the one or more patient parameters, wherein the components of the ROX index are: respiratory rate, SpO2, and / or FiO2, FdO2 and / or O2 fraction, and - Determine a vector representing the change in the ROX index, wherein the vector includes a magnitude representing the rate of change of the ROX index and a direction representing the direction of the change in the ROX index. - The following combined graphic representation is displayed on the monitor: --The ROX index. --One or more components of the ROX index, and --The vector, and - The patient's respiratory status is determined by the vector.

2. The system according to claim 1, wherein, The patient is receiving respiratory support, which is high-flow respiratory support, and / or during the period described above: It is the treatment period. A day or part of a day One night or part of one night, During the Zi period, A certain length of time.

3. The system of claim 1, wherein the system includes means configured to provide the respiratory support.

4. The system according to claim 1, wherein, The respiratory rate is determined by the controller from one or more patient parameters received from the one or more sensors.

5. The system according to any one of claims 1 to 4, wherein, Determining the patient's respiratory status includes the controller calculating and comparing the vector against a threshold.

6. The system according to claim 5, wherein, The threshold is a threshold that indicates the risk of respiratory failure.

7. The system of claim 5, further comprising the step of the controller displaying the threshold.

8. The system according to any one of claims 1 to 4, comprising the step of determining a plurality of instantaneous vectors that vary over time, each instantaneous vector indicating the change of the ROX exponent at a time.

9. The system according to any one of claims 1 to 4, further comprising transmitting the determined vector communication showing the ROX exponent change to: Clinicians, for example, in the form of messages, alerts, respiratory status, ROX index and / or Respiratory support device.

10. The system according to any one of claims 1 to 4, wherein, The system may be individually or integratedly comprise one or more of the following: Breathing equipment mobile device, Remote monitoring system.

11. The system according to any one of claims 1 to 4, wherein, The system is configured to determine whether changes in respiratory support are needed based on the patient's respiratory status.

12. The system according to any one of claims 1 to 4, wherein, ROX vectors are color-coded based on the direction of ROX vectors.

13. The system according to any one of claims 1 to 4, wherein, The ROX vector is calculated between two consecutive ROX exponent values.

14. The system according to any one of claims 1 to 4, wherein, The graphical representation of one or more components includes a graphical representation of the relationship between respiratory rate and FiO2 or the relationship between respiratory rate and SpO2 / FiO2.

15. The system according to any one of claims 1 to 4, wherein, When the patient's breathing status is determined, an alarm sounds and / or a message is displayed.

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