Non-invasive ventilation trend alert system

Abstract

Title of the invention Non-invasive ventilation trend alert system The invention relates to a remote monitoring system (1, 10, 20) of one or more non-invasive ventilation (NIV) parameters of at least one patient under non-invasive ventilation (NIV) treated at home comprising computer data processing means (10) comprising data reception means configured to receive said at least one ventilation parameter originating from a medical ventilator (1) and transmitted by data transmission means (2, 3, 4) collecting said at least one ventilation parameter of said medical ventilator, and at least one processor implementing at least one algorithm to process said at least one ventilation parameter and obtain at least one processed value of said at least one ventilation parameter;comparing said at least one processed value with at least one stored threshold value, and triggering an alert when said at least one processed value exceeds said at least one stored threshold value; and alert means (20) configured to warn or inform a user (21) in response to an alert being triggered by said at least one processor of the data processing computer means (10). Preferably, it further comprises a medical ventilator (1) comprising parameter measuring means configured to measure at least one ventilatory parameter, in particular the respiratory rate or the duration of use. Abstract figure: Fig. 1;

Description

Title of the invention: Non-invasive ventilation trend alert system

[0001] The invention relates to a remote monitoring system, i.e. a medical device for remote monitoring, of one (or more) patients undergoing non-invasive ventilation (NIV) treated at home, comprising computer data processing means for remotely detecting ventilation operated by a medical ventilator, which is not or not sufficiently effective or a clinical condition which is deteriorating in the patient and alert means configured to inform and / or alert a user in the event of such detection, in particular a home health provider (HHP).

[0002] Chronic respiratory failure is defined by the permanent inability of the respiratory system to properly oxygenate the blood at rest. It constitutes a severe handicap limiting the daily life of patients and impacting their life expectancy.

[0003] Patients with severe chronic respiratory failure sometimes require the initiation of non-invasive ventilation (NIV) at home, i.e. outside of a hospital or similar setting, and for long periods, typically several months or years. During NIV, mechanical support is provided to the action of the respiratory muscles by insufflating a respiratory gas into the patient's airways using a respiratory assistance device, also called a medical ventilator, delivering the respiratory gas under positive pressure, typically air, possibly enriched with oxygen.

[0004] NIV is a treatment that patients use at night and for a few hours during the day or permanently, depending on the severity of their respiratory failure. The main pathologies that can lead to severe chronic respiratory failure are chronic obstructive pulmonary disease (COPD), obesity-hypoventilation syndrome (OHS), restrictive respiratory diseases such as kyphoscoliosis or pulmonary fibrosis, neuromuscular diseases such as amyotrophic lateral sclerosis or Duchenne muscular dystrophy. In France, approximately 60,000 patients are treated with mechanical ventilation at home (source: ameli.fr).

[0005] Monitoring patients with respiratory failure treated with non-invasive ventilation at home requires regular visits by professionals (technician and / or nurse) to the patient's home, every two to four months, in particular to check clinical efficacy, compliance and the occurrence of any adverse effects and to take detailed readings of the ventilator, intended for the prescribing physician. This monitoring makes it possible to take actions aimed at reinforcing compliance, limiting the effects (such as mask leaks) and to make adjustments or adjustments to ventilator settings to improve ventilation efficiency. Indeed, the target ventilator settings, as well as the parameters to be medically monitored, depend on the underlying pathology(ies) and are specific to each patient.

[0006] During these visits, the data stored by the ventilator are downloaded and retrieved by the technician so as to enable him, and also the prescribing physician, to analyze the patient's treatment monitoring, its tolerance and therefore its effectiveness over the past months and possibly allow adjustments to the ventilator parameters or adjustments (changing the mask, etc.).

[0007] However, despite these regular monitorings, many (i.e. > 30%) patients receiving NIV at home are treated in a manner that is not entirely effective due to poorly adapted settings or other reasons, such as weariness or discouragement of the patient leading to a drop in compliance with their treatment, the occurrence of a technical problem (e.g. ventilator, mask, etc.) generating leaks or asynchrony between the patient and the ventilator, etc.

[0008] Variations in measured physiological parameters, such as respiratory rate, could also contribute to rapidly and remotely detecting the occurrence of acute respiratory events in certain patients, such as exacerbations in patients with COPD, allowing for earlier diagnosis, and therefore potentially at a less severe stage, of the acute event.

[0009] However, we understand that this situation is not ideal and that there is a need to be able to improve the monitoring of treatment of patients receiving NIV at home.

[0010] In other words, the problem that arises is to be able to quickly detect ineffective or insufficient NIV or a deteriorating state of health in a patient under NIV treated at home with a medical ventilator, in order to intervene quickly and avoid an impact on the state of health of said patient.

[0011] The solution of the invention relates to a remote monitoring system, i.e. a medical device for remote monitoring, of one or more non-invasive ventilation (NIV) parameters of at least one patient treated at home, comprising:

[0012] - computer means for processing data comprising: • data receiving means configured to receive said at least one ventilatory parameter from a medical ventilator and transmitted by data transmission means collecting said at least one ventilatory parameter from said medical ventilator, and • at least one processor implementing at least one algorithm for:

[0013] i. processing said at least one ventilatory parameter and obtaining at least one processed value of said at least one ventilatory parameter, ii. comparing said at least one processed value with at least one stored threshold value, and iii. trigger an alert when said at least one processed value exceeds said at least one stored threshold value,

[0014] - and alert means configured to warn or inform a user in response to an alert being triggered by said at least one processor of the data processing computer means.

[0015] Depending on the embodiment considered, the monitoring system of the invention may comprise one or more of the following characteristics:

[0016] - it further comprises a medical ventilator, i.e. a respiratory assistance device, comprising parameter measuring means configured to determine at least one ventilatory parameter. - the medical ventilator further comprises data transmission means, for example a modem or the like, configured to remotely transmit at least said ventilation parameter. The data transmission means may either be integrated into the ventilator or be part of an external module cooperating with the ventilator, for example being attached or connected to said medical ventilator. - the alert triggered by the alert means in order to warn or inform the user, includes a prior notification, for example one or more characters (letters, numbers or others), in particular a message in text format, a color code, an icon, a bar graph, or other and / or their combinations, for example a bar graph of several colors. - the ventilatory parameter(s) from the medical ventilator include one or more primary parameters selected from respiratory rate (RR), leak, abnormal respiratory event (e.g. apneas, hypopneas, etc.) and / or treatment duration, preferably respiratory rate (RR) and treatment duration.

[0017] - the ventilatory parameter(s) from the medical ventilator comprise one or more secondary parameters chosen from the tidal volume (Vt), the proportion (i.e. %) of spontaneous inspirations (relative to the total number of inspiratory cycles, i.e. triggered by the ventilator and the patient), and the minute ventilation. - the parameter(s) from the medical ventilator further include one or more operating parameters, in particular information relating to a lack of data transmission by the medical ventilator. This makes it possible to warn the user (e.g. PS AD) of a fault or malfunction of the ventilator affecting the correct transmission of data, ie pa meters. the parameter(s) are determined and / or measured over a given period which can be modified by a user, in particular PSAD or healthcare personnel. an indicator of change in the duration of use (i.e. of the processed value) is a relative interquartile coefficient determined on the last n measurements (n>l), for example n=8, i.e. over a period of x consecutive days (x>l). The threshold value of the relative interquartile coefficient is set at 20% to trigger an alert of variation in the usage profile upwards, and excluding days when daily use is less than 360 minutes. The microprocessor algorithm is configured to look for an upward trend: between the first and last day, the data must increase by at least 120 minutes for the indicator of modification of the duration of use. Thanks to this calculation method, the algorithm is not very sensitive to disturbances generated by extreme values. Since the indicator is invariant by change of scale, it is not necessary to adjust the threshold according to the patient. a respiratory rate (RR) change indicator (i.e. processed value) is a rate of variation between the standard deviation determined on the last n (n>l) measurements received (for example D-10; D) and the standard deviation determined on the n penultimate measurements (for example D-11; Dl). The threshold value is set at a few %, for example of the order of 5%, for several days, for example 2 days, to trigger an alert for a variation in the respiratory rate. The microprocessor algorithm is configured to be able to search for an upward and / or downward trend, for example between the first and last day, the data must increase by at least 1 cycle / minute for the indicator of an upward change in respiratory rate (RR). The algorithm is also configured to check the relevance of the data used in the calculation. Irrelevant data is removed and is not used to perform the calculation(s). If the algorithm has fewer than 5 valid data, for example, the calculation of the variation indicator does not take place. A calculation is considered irrelevant if leaks are too high. For the calculation of the respiratory rate variation indicator, a too short duration of use is also a criterion of irrelevance. the medical ventilator supplies air or an air / oxygen mixture at a pressure higher than atmospheric pressure (i.e. 1 bar absolute), the data transmission means comprise a modem or the like, the computer data processing means comprise at least one computer server. - the processor is a microprocessor. - the processor is arranged on an electronic card. - it comprises data storage means configured to store the ventilatory parameter(s) from the medical ventilator and / or at least one threshold value. - the data storage means are configured to store at least one respiratory rate and / or duration of use alert threshold value. - the alert means include a display, i.e. a viewing screen, configured to display a visual alert. - alert means include a computer, a digital tablet or a smartphone.

[0018] In the context of the present invention:

[0019] - the duration of use of non-invasive ventilation is the duration during which the patient has used the ventilator during a given period of time, for example one day (i.e. 24 hours). Several successive durations of use make it possible to determine an upward or downward trend in the use of the ventilator by the patient and / or a fragmentation of this use. - Respiratory rate (RR) is the number of respiratory cycles, i.e. inspiration and expiration phases, per unit of time, measured in a patient, for example it is 12 to 20 cycles per minute (cycles / min) in a healthy adult but which can increase in the event of respiratory disorders or decrease during sleep. - Leaks are air leaks or escapes around the mask, limiting the effectiveness of ventilation and causing discomfort for the patient. Leaks are estimated by the ventilator, for example, from measured gas flow rates. - The proportion (%) of spontaneous inspirations corresponds to the percentage of respiratory cycles that are initiated by the patient, and not by the ventilator, in relation to the total number of cycles. - the number of respiratory events (i.e. apneas, hypopneas) per hour of treatment corresponds to the number of stops and / or decreases in airflow during a given period of time, for example greater than or equal to 10 seconds, also called the apnea-hypopnea index. - tidal volume (Vt) is the volume of air entering the patient's lungs during each respiratory cycle, for example an air volume of approximately 0.5 L. - the minute ventilation corresponds to the Vt.FR product.

[0020] The invention also relates to a use of a system according to the invention for monitoring a patient suffering from severe chronic respiratory failure, in particular chronic obstructive pulmonary disease (COPD), obesity-hypoventilation syndrome (OHS), or a neuromuscular disease, such as amyotrophic lateral sclerosis or Duchenne muscular dystrophy.

[0021] The invention will now be better understood thanks to the following detailed description, given for illustrative but non-limiting purposes, with reference to:

[0022] [fig. 1] which diagrams a system for monitoring a patient under non-invasive ventilation (NIV) according to the invention.

[0023] [fig.l] schematizes a monitoring system 1, 10, 20 of a patient under non-invasive ventilation (NIV) treated at home for severe chronic respiratory failure, in particular chronic obstructive pulmonary disease (COPD), obesity-hypoventilation syndrome (OHS) or a neuromuscular disease, such as amyotrophic lateral sclerosis or Duchenne muscular dystrophy.

[0024] As part of his treatment, the patient receives a pressurized respiratory assistance gas (i.e. > 1 bar abs), such as air or an air / O2 mixture, delivered by a medical ventilator 1, i.e. a respiratory assistance device. Conventionally, the gas is conveyed to the patient's airways by a flexible hose fluidically connected to the ventilator 1 and equipped with a patient respiratory interface, such as a mask or the like (not shown).

[0025] Furthermore, the medical ventilator 1 is electrically powered by the electrical network (110 / 220V) or by one or more internal batteries, in particular rechargeable batteries, or the like. The medical ventilator 1 comprises parameter measuring means configured to monitor one or more ventilatory parameters, such as for example the respiratory frequency (expressed in cycles / min) and the duration of use (expressed in min for example) of the ventilator by the patient which reflects the duration during which the patient has inhaled respiratory gas, i.e. has followed his treatment.

[0026] Also provided are data transmission means configured to remotely transmit at least the ventilation parameters provided by the parameter measurement means, for example they comprise a GSM or other type modem and a transmitting antenna. The transmitted parameters preferably transit via the internet network 2 or another network 3, such as the GSM, Lora or Sigfox networks, and / or can be processed in the virtual computing space 4 or “cloud”.

[0027] The processing of the parameters is carried out via computer data processing means 10 comprising data reception means, configured to receive the ventilatory parameters transmitted remotely by the data transmission means. data from fan 1, as well as one (or more) processors implementing one or more algorithms.

[0028] Preferably, each day, the system of the invention records the latest data transmitted by the ventilator 1, in particular the duration of use and the respiratory rate (RR) and this, for several consecutive days, preferably between 5 and 10 days.

[0029] To do this, the system 1 of the invention also comprises data storage means configured to store the ventilatory parameter(s) originating from the medical ventilator 1, for example a data storage memory card. Each day, the latest data, i.e. the most recent ventilatory parameter(s) not yet sent, transmitted by the ventilator 1 are stored therein.

[0030] Furthermore, at least one algorithm implemented by a microprocessor is used to process the measured or determined ventilatory parameter(s) and compare the result(s) of this processing with one or more threshold values, and trigger an alert when this or these ventilatory parameter(s) exceed the threshold value(s) considered.

[0031] For example, the respiratory rate (RR) and the duration of use of the ventilator by the patient may be used as parameters that are processed to obtain one or more indicators, which are then compared to one or more predefined threshold values, and possibly trigger an alert to inform the user. For example, the indicator(s) may be a relative interquartile coefficient or a rate or proportion of variation between the standard deviations.

[0032] Thus, as an indicator of change in the duration of use (i.e. as a processed value of duration of use), the relative interquartile coefficient determined over the last n measurements (n>l), for example n=8, i.e. over a period of x consecutive days (x>l) can be used. The threshold value of this relative interquartile coefficient is set at 20% to trigger an alert for an upward variation in the usage profile, while excluding days when daily use is less than 360 minutes. The microprocessor algorithm is configured to look for an upward trend, i.e. between the first and last day, the data must increase by at least 120 minutes for the indicator of change in the duration of use. Thanks to this calculation method, the algorithm is not very sensitive to disturbances generated by extreme values.Since the indicator is invariant to changes in scale, it is not necessary to adjust the threshold according to the patient.

[0033] Furthermore, it is possible to use as an indicator of change in the respiratory rate (RR) (i.e. the processed respiratory rate value), the rate (i.e. proportion) of variation between the standard deviation determined on the last n (n>1) measurements received (by example D-10; D) and the standard deviation determined on the n penultimate measurements (for example D-11; Dl). The threshold value is set at a few %, for example of the order of 5%, for several days, for example 2 days, to trigger an alert for variation in respiratory rate. The microprocessor algorithm is configured to be able to search for an upward and / or downward trend, for example between the first and last day, the data must increase by at least 1 cycle / minute for the indicator of upward modification of respiratory rate (RR).

[0034] The threshold values ​​set for triggering one or more alerts have a clear physical meaning. In addition, since the indicator is invariant to changes in scale, it is not necessary to adjust the threshold values ​​depending on the patient.

[0035] Indeed, the only cases where the algorithm might not be suitable correspond to median values ​​of zero or very close to 0. However, since the respiratory rate in a patient is never (quasi)zero, it is always possible to determine an inter-quartile range in a given patient, for example over several days, and to compare them with corresponding threshold values.

[0036] As for the breathing duration, this can be (almost) zero, in particular if the patient does not use his treatment for several days, for example for more than 3 days out of the 8 days retained. However, in this case, the algorithm is configured to first check this situation (i.e. zero breathing duration) and alert immediately, if necessary.

[0037] Generally speaking, the relative interquartile coefficient or the standard deviation used by the algorithm in the context of the present invention are notably explained and illustrated by the following websites:

[0038] http: / / grasland.script.univ-paris-diderot.fr / STAT98 / stat98 4 / stat98 4.htm

[0039] http: / / margaux.ipt.univ-paris8.fr / vgodard / enseigne / statisti / memostat / mem41sta.htm

[0040] In the context of the present invention, the algorithm is preferably hosted on one or more central servers 11 and makes it possible to remotely process the measurements (i.e. measured parameters), in particular the respiratory rate (RR) and / or the duration of use carried out over several days, and transmitted remotely by the communicating ventilator 1 located at the patient's home.

[0041] Furthermore, alert means 20 are also provided, configured to alert a user 21, such as a home health care provider (HHP), in response to an alert being triggered by the processor of the data processing computer means 10.

[0042] In other words, the algorithm calculates for each patient, one or more indicators of modification of the parameters in relation to the patient's parameters, in particular respiratory rate (RR) and duration of use, evaluated over a reference period, for example over several days, for example between 4 and 15 days, and if one of these indicators indicators exceeds a pre-programmed and / or stored threshold value, an alert notification is triggered for this patient in order to inform and / or warn the user 21, such as a home care provider (PSAD), that it may be necessary to intervene at the home of the patient in question.

[0043] The alert notification triggered by the alert means may take the form of a visual alert, such as a notification, displayed on a display screen 22, such as a computer, telephone or digital tablet display. The notification may include, for example, one or more characters (i.e., letters, numbers or other symbols), in particular a message in text format, but also a color code, an icon, a bar graph or any other graphic representation, and / or their combinations, for example a bar graph of several colors, for example green, yellow, storm and red depending on the severity of the alert.

[0044] Generally speaking, the system of the invention makes it possible to remotely detect an ineffective, insufficient or deteriorating NIV in a given patient, and to alert a user 21, such as a PSAD, to enable him to intervene quickly at the patient's home so as to avoid or minimize any negative impact on the state of health of said patient. The system of the invention therefore makes it possible to quickly, efficiently and remotely detect one or more elements / indicators representative of an NIV type ventilation which is not or not sufficiently effective or which is deteriorating, and thus to put in place technical corrective actions or to inform health professionals about a drop in compliance or an excessively significant variation in the patient's respiratory rate, which may be a precursor sign of deterioration in the state of health of this patient.

[0045] The invention is intended for use for medical purposes because it can provide assistance with diagnosis (e.g. detection of a deterioration in health) or treatment. It provides a specific result for the benefit of a single patient. It includes an analysis carried out on the incoming data (i.e. physiological and / or technical signals) specific to a patient in order to provide new information and is equipped with alert functions for medical purposes. As such, it meets the criteria of a class IIA medical device.

[0046] Generally speaking, the system of the invention is compatible with all communicating fans 1 and is furthermore capable of censoring the parameters measured during periods of compliance that are too short so that the value is relevant.

Claims

1. Claims Remote monitoring system (1, 10, 20) of one or more non-invasive ventilation (NIV) parameters chosen from the respiratory rate (RR) and the duration of treatment of at least one patient under non-invasive ventilation (NIV) treated at home comprising: - computer data processing means (10) comprising: • data receiving means configured to receive said at least one ventilatory parameter from a medical ventilator (1) and transmitted by data transmission means (2, 3, 4) collecting said at least one ventilatory parameter from said medical ventilator, and • at least one processor implementing at least one algorithm for: a. processing said at least one ventilatory parameter and obtaining at least one processed value of said at least one ventilatory parameter, b. comparing said at least one processed value with at least one stored threshold value, and c. trigger an alert when said at least one processed value exceeds said at least one stored threshold value, - and alert means (20) configured to warn or inform a user (21) in response to an alert being triggered by said at least one processor of the data processing computer means (10), characterized in that: a. the microprocessor algorithm is configured to: i. look for a change in the duration of use from a relative interquartile coefficient determined from several measurements taken over a given period of 5 to 10 consecutive days, and ii. trigger an alert for an increase in the usage profile when the determined relative interquartile coefficient exceeds 20% and the usage duration has increased by at least 120 minutes during said given period, or a. the microprocessor algorithm is configured to: i. search for a change in the respiratory rate (RR) from the rate of variation between the standard deviation determined on the last measurements received (D-10; D) and the standard deviation determined on the n penultimate measurements (D-ll; Dl), and ii. trigger an alert for a variation in the respiratory rate (RR) when the determined rate exceeds a threshold value set at 5%, over several consecutive days.

2. System according to the preceding claim, characterized in that it further comprises a medical ventilator (1) comprising parameter measuring means configured to measure at least one ventilatory parameter.

3. System according to one of the preceding claims, characterized in that the medical ventilator (1) comprises data transmission means configured to remotely transmit at least said ventilatory parameter.

4. System according to one of the preceding claims, characterized in that the alert means (20) comprise a display screen (22) configured to display a visual alert.

5. System according to one of the preceding claims, characterized in that the alert means (20) comprise a computer, a digital tablet or a smartphone.

6. System according to one of the preceding claims, characterized in that the data processing computer means (10) comprise at least one computer server (11).

7. System according to one of the preceding claims, characterized in that that said at least one ventilatory parameter from the medical ventilator (1) further comprises at least one other primary parameter chosen from leakage and an abnormal respiratory event.

8. System according to one of the preceding claims, characterized in that said at least one ventilatory parameter coming from the medical ventilator (1) comprises at least one secondary parameter chosen from the tidal volume (Vt), the proportion (%) of spontaneous inspirations and the minute ventilation.

9. System according to one of the preceding claims, characterized in that said at least one ventilatory parameter originating from the medical ventilator (1) further comprises one or more operating parameters, in particular information relating to an absence of data transmission by the medical ventilator (1).

10. System according to one of the preceding claims, characterized in that it comprises data storage means configured to store the ventilatory parameter(s) coming from the medical ventilator (1) and / or at least one threshold value, in particular at least one respiratory rate and / or duration of use alert threshold value.

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