Ventilation method
Patent Information
- Application Number
- PCT/EP2025/087406
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-02-18
- Filing Date
- 2025-12-16
- Publication Date
- 2026-08-27
Smart Images
Figure EP2025087406_27082026_PF_FP_ABST
Abstract
Description
[0001] Ventilation procedures
[0002] The present invention relates to a method for assessing the effectiveness of drug delivery by nebulization during ventilation of a patient with a ventilation system, in particular when drug delivery is carried out by a nebulizing device.
[0003] In clinical practice, patients receiving mechanical ventilation via a respiratory system are often treated with inhaled medications. The core components of a respiratory system are a ventilator, which mixes ambient air and oxygen to create a breathing gas, delivers it at defined pressures and volumes, and offers multiple ventilation modes; a breathing circuit with flexible tubes that transport the breathing gas from the ventilator to the patient; a patient port connecting the respiratory system to the patient via a mask / nasal cannula or an invasive access point; and a nebulizer, typically attached to the inspiratory branch of the breathing circuit, for medication delivery.
[0004] However, existing systems and methods for drug delivery during mechanical ventilation have several drawbacks. For example, a significant portion of the nebulized substance accumulates in the breathing circuit or the (optional) humidification system instead of reaching the lungs. This makes drug deposition inefficient and unpredictable. Often, standardized drug delivery via the nebulizer without considering the respiratory cycle results in suboptimal drug uptake. Furthermore, operating personnel typically have no direct information during ventilation, beyond their usual experience, to determine whether and how the drug delivery is actually affecting the patient.
[0005] It is therefore the object of the present invention to provide a method for assessing the effectiveness of drug delivery by nebulization during ventilation of a patient with a ventilation system, which overcomes at least some of the aforementioned disadvantages, makes the drug effectiveness during ventilation visible, indicates drug losses, and / or optimizes settings to be made by personnel for better drug deposition in the lungs and enables effective adjustment or control of ventilation.
[0006] 15045 P 4981 WO This problem is solved by the subject matter with the features of independent claim 1. Advantageous embodiments are described in the dependent claims.
[0007] According to one embodiment of the invention, a method for assessing the effectiveness of drug delivery by nebulization during ventilation of a patient with a ventilation system is provided, wherein the method comprises the following steps: providing a ventilation system comprising a ventilator, a control unit, a nebulization device for drug delivery, and a display unit, which are communicatively connected to one another; providing data from the ventilation system during ventilation with a predetermined ventilation mode; providing data from the nebulization device during ventilation; determining a respiratory mechanics parameter at two time points as a first and a second measurement value, wherein nebulization takes place between the time points;Determining a nebulization efficiency parameter by the control unit, which allows a statement about the influence of the drug delivery on the patient, and displaying the nebulization efficiency parameter in the display unit.
[0008] The nebulization device can be of different types, for example a jet nebulizer that uses compressed air or oxygen as a propellant, an ultrasonic nebulizer that generates fine particles without additional gas flow, or a vibrating membrane or mesh nebulizer that generates fine particle size with high efficiency and is suitable and optimized for use in mechanical ventilation.
[0009] The display unit can be integrated into one or more components of the ventilation system, preferably the ventilator, as this is typically the central device used to configure ventilation settings and display data during ventilation monitoring. However, the communicative integration of all components of the ventilation system also allows, for example, the display unit to show data from the nebulizer or an optional humidifier. Input of control parameters for the nebulizer and other components via the display unit is also possible. The display unit can include several different displays and / or display types, such as a screen, LEDs, traffic light-style indicators, combinations thereof, and the like.One or more control elements such as a display that is at least partially touch-sensitive, buttons, rotary knobs, or sliders.
[0010] 15045 P 4981 WO or combinations thereof may be configured on the display device. The display device may include elements for reproducing acoustic or haptic signals, such as loudspeakers, buzzers, vibration elements, and the like. The display device may also be configured as a touchscreen, thus simultaneously providing both display and control elements.
[0011] Determining a respiratory mechanics parameter at two time points (the first and second measurements) with a nebulization period between the two points in time means that one time point can occur during the nebulization period, or one time point before a specific nebulization duration and the other time point after this nebulization duration. Consequently, no respiratory mechanics parameter will be determined at two time points if no nebulization takes place between the two points in time, e.g., during the same pause in a nebulization period.
[0012] By recording and displaying at least one nebulization efficiency parameter based on the first and second recorded values of the respiratory mechanics parameter, operating personnel are able to immediately recognize the effect of medication delivery on the patient and take appropriate action. The nebulization efficiency parameter can, for example, be based on the ratio of the first and second recorded values or the difference between them. Changes in the respiratory mechanics parameter are evaluated and displayed. Trends regarding nebulization efficiency during ventilation treatment can thus be understood early on. This allows for adjustments to the ventilation mode, reduction, increase, or cessation of medication delivery, or, in cases of uncertainty regarding the data, consultation with more highly qualified medical personnel.The procedure serves solely to collect and evaluate the recorded data, without prescribing specific decisions or conclusions for ventilation treatment. It also does not directly influence clinical or physiological parameters, but rather collects technical data, evaluates it if necessary, and displays it so that medical professionals can assess the situation and take further action.
[0013] The ventilation mode can be selected from the group that includes the following elements: volume-controlled ventilation, pressure-controlled ventilation, adaptive support ventilation, pressure-supported spontaneous breathing, bilevel ventilation, and lung recruitment maneuvers.
[0014] 15045 P 4981 WO In volume-controlled ventilation (VCV), the tidal volume (V TThe pressure is fixed, but can vary. The ventilation cycle is completely controlled by the device. This ventilation mode is particularly suitable for patients with poor spontaneous breathing (e.g., coma, ARDS).
[0015] In contrast, with pressure-controlled ventilation (PCV), the pressure is set at a fixed level, and the volume varies depending on lung elasticity and compliance. The ventilator ensures a constant pressure delivery, and expiration occurs passively. Therefore, PCV is primarily used in patients with reduced lung compliance (e.g., ARDS, pulmonary fibrosis), i.e., when high ventilation pressure must be avoided.
[0016] Adaptive Support Ventilation (ASV) is an intelligent ventilation control system that dynamically adapts to the patient's breathing and optimizes ventilation in real time. ASV is a pressure-controlled, volume-adaptive ventilation mode that automatically adjusts the respiratory rate, tidal volume, and inspiratory time. The ventilator uses a mathematical model of respiratory mechanics (based on the theories of Otis and Mead) to control ventilation in a way that minimizes the work of breathing and achieves efficient CO2 elimination. ASV takes into account airway resistance, lung compliance, dead space ventilation, and spontaneous respiratory activity. More precisely, during ASV operation, the time constant, a respiratory mechanics parameter defined as the product of compliance and resistance, is determined regularly, potentially even per breath.The advantages of ASV include automatic adaptation of ventilation to changing lung mechanics, e.g., after weaning or in pulmonary diseases such as COPD or ARDS, as well as a reduction in the patient's work of breathing, allowing a patient to be gradually brought back to spontaneous breathing. Furthermore, ASV automatically limits airway pressures to prevent lung overinflation. It is easy for operators to use, as no constant manual adjustment of ventilation settings is necessary. For further information, please refer to the publication by Fernandez, J. et al., "Adaptive support ventilation: State of the art review," Indian J Crit Care Med. 2013 Jan; 17(1): 16-22, the contents of which are hereby incorporated in their entirety into this disclosure.
[0017] 15045 P 4981 WO Other possible ventilation modes include assisted ventilation modes, in which the patient breathes spontaneously and is supported by the ventilation system with each breath. These include pressure support ventilation (PSV) and bilevel ventilation (BiPAP). In pressure support ventilation, the ventilator assists each breath with a pressure boost, with the duration of inspiration determined by the patient. Bilevel ventilation uses two pressure levels, providing support during inhalation and preventing airway collapse. For example, COPD patients require intermittent support.
[0018] A ventilation mode can be a (lung) recruitment maneuver. A recruitment maneuver is a targeted technique aimed at reopening collapsed alveoli by briefly increasing the ventilation pressure (recruitment) to improve gas exchange in the lungs. It is also referred to as "artificial yawning." The purpose of applying a recruitment maneuver can also be to determine the current compliance as a respiratory-mechanical parameter of the patient's lungs. Details regarding the recruitment maneuver as a ventilation mode are described, for example, in EP1455877B1 and US5876352A, the contents of which are hereby incorporated in full into the present disclosure.
[0019] Depending on the ventilation mode, additional ventilation parameters can be set on the ventilator. These ventilation parameters can be selected from the following group: ventilation pressure, airflow, tidal volume, respiratory rate, inspiratory time (I), expiratory time (E), inspiratory to expiratory time ratio (I:E), flow pattern, and other adjustable parameters such as clinical patient parameters.
[0020] Ventilation pressure is one of the most important parameters in mechanical ventilation and determines the force with which the breathing gas is delivered into the lungs. Characteristic pressure types include peak inspiratory pressure (PIP), which is the highest pressure reached in the airways during inspiration. PIP depends on lung compliance and airway resistance and is individually set for each patient or maintained within a normal range of approximately 15–30 cmH₂O. Plateau pressure (PPP) is the pressure at the end of inspiration, when there is no more airflow, and is a marker for lung compliance. Positive end-expiratory pressure (PEEP) is the pressure in the lungs at the end of expiratory phase.
[0021] 15045 P 4981 WOA remains in the airways. PEEP prevents alveolar collapse and improves gas exchange. Typical PEEP values are 5–10 cmH2O.
[0022] The tidal volume (V) T ) is the volume delivered to the lungs with each breath.
[0023] Airflow is the rate at which respiratory gases are supplied and indicates how quickly a given volume of respiratory gas flows into the lungs per unit of time during inspiration. Typical airflow rates are approximately 30–60 liters per minute. Regarding the flow pattern, airflow does not have to be constant (square wave) but can also be decelerating, meaning it is high at the beginning of inspiration and then decreases.
[0024] Inspiration time (I) is the duration of inhalation, i.e., the time spent inhaling. Normal inspiration time is approximately 0.8–1.2 seconds. Expiration time (E) is the duration of exhalation, i.e., the time spent exhaling. It should be long enough to prevent air from becoming trapped. The I:E ratio (inspiration-to-expiration ratio) indicates how long inhalation lasts compared to exhalation. Typical values are, for example, 1:2, i.e., inhalation is half as long as exhalation, or 1:3 to 1:4 in patients with obstructive airways.
[0025] Other ventilation parameters can be clinical parameters of the patient such as blood pressure, cardiac output, central venous pressure, metabolic parameters, pH value, heart rate, blood parameters, body temperature, body weight, age, oxygen saturation, neurological diseases, neuromuscular diseases or nutritional status.
[0026] In some embodiments, the respiratory mechanics parameter can be selected from the following group:
[0027] Lung compliance C, where: C = AV / AP with AV = change in tidal volume (in ml or L) and AP = change in pressure (in cm H2O or kPa) dynamic lung compliance Cd yn , where: Cdyn = V T / (P P eak - PEEP) with V T = Tidal volume (ml or L),
[0028] Ppeak = Peak Inspiratory Pressure (PIP)
[0029] PEEP = Positive end-expiratory pressure
[0030] Static lung compliance Cstat, where: Cstat = V T / (Piat-PEEP)
[0031] 15045 P 4981 WOPpiat plateau pressure (measured after a short inspirational pause) Specific lung compliance C spe c, where: C spe c = C s tat / FRC
[0032] FRC: functional residual capacity
[0033] Airway resistance (R; Resistance)
[0034] FRC: functional residual capacity
[0035] Time constant T = R x C
[0036] maximum flow rate V ma x
[0037] Otis respiratory rate.
[0038] The nebulization efficiency parameter is a measure of a change in characteristic respiratory mechanics parameters. This change in the respiratory mechanics parameter(s) is calculated using a corresponding formula or algorithm based on the recorded values.
[0039] The nebulization efficiency parameter can be understood here as a measure of how the nebulization of a medication directly affects the ventilated patient—essentially a ventilation response parameter. The operator should be able to directly perceive the effect of the medication delivery in the patient's lungs by observing this parameter. The nebulization efficiency parameter is therefore a direct or indirect measurement that considers the patient's lung mechanics and thus provides feedback on the effect of the delivered medication on the patient's lungs. It should be noted that not only a single nebulization efficiency parameter, but also a combination of two or more nebulization efficiency parameters, or changes in their values, can be calculated and subsequently displayed.It should be noted that this only involves the presentation and, where applicable, the evaluation of the measured values, but no direct feedback on ventilation parameters. Therefore, the method disclosed here does not result in any changes to medication delivery or ventilation treatment.
[0040] Exemplary nebulization efficiency parameters include the change in lung elasticity or lung compliance (C), which describes the lung's distensibility and indicates how much volume change (AV) occurs per pressure change (AP) in the airways. It is expressed in ml / cmH2O or L / kPa. A distinction is made between dynamic lung compliance Cd. yn = VT / (Ppeak - PEEP), where VT is the tidal volume (in ml or L), Ppeak is the peak inspiratory pressure (PIP), and PEEP is the positive end-tidal pressure.
[0041] 15045 P 4981 W Aspiratory pressure is the static lung compliance Cstat = VT / (Pplat - PEEP), where Pplat is the plateau pressure measured after a short inspirational pause, and the specific lung compliance C spe c = Cstat / FRC, where FRC stands for functional residual capacity, i.e., the volume of air that remains in the lungs after a normal expiration.
[0042] Another important nebulization efficiency parameter, besides changes in lung compliance, is the change in airway resistance, or resistance R = AP / V, where AP is the pressure difference between the mouth / nose and the alveoli, measured in cmH₂O, and V is the respiratory flow rate, measured in L / s (i.e., the derivative of volume). Normal values for resistance R range from 0.5 to 2.5 cmH₂O / L / s. Airway resistance is a measure of how difficult it is for respiratory gases to flow through the airways during mechanical ventilation.
[0043] The product of airway resistance R and lung compliance C yields the time constant T = R x c, which indicates how quickly the lungs fill with air during inhalation or empty during exhalation, i.e., how long it takes for 63% of a pressure-volume change to be completed. After three time constants (approximately 95%), lung filling or emptying is nearly complete. A short time constant (low resistance or low compliance) means that the breathing gas fills and empties quickly, typical in restrictive lung diseases (e.g., ARDS, pulmonary fibrosis). A long time constant (high resistance or high compliance) means that the breathing gas fills and empties slowly, typical in obstructive lung diseases (e.g., COPD, asthma). Thus, a change in the time constant T is also a nebulization efficiency parameter.
[0044] The Otis respiratory rate, also called the optimal respiratory rate according to Otis, is based on a mathematical model of the work of breathing and describes the frequency at which the work of breathing is minimal and gas exchange is optimal.
[0045] In an advantageous embodiment, the Otis ventilation rate is selected as the respiratory mechanical parameter and ASV as the ventilation mode.
[0046] In a preferred embodiment, the time constant T is chosen as the respiratory mechanics parameter and ASV as the ventilation mode.
[0047] 15045 P 4981 WOAnother embodiment selects lung compliance as the respiratory mechanics parameter and the lung recruitment maneuver as the ventilation mode.
[0048] In another embodiment, a peak pressure (Ppeak) is selected as the respiratory mechanics parameter and the VCV mode as the ventilation mode.
[0049] One embodiment selects the maximum flow rate or V as the respiratory mechanics parameter. max and PCV mode as the ventilation mode.
[0050] The combinations mentioned here have proven useful and suitable, as certain ventilation modes are better suited to specific respiratory mechanics parameters than others. A lung recruitment maneuver, for example, can last from a few to over 100 breaths and therefore lasts between approximately 5 and 30 seconds. Accordingly, a suitable respiratory mechanics parameter, such as compliance or resistance, is selected to determine nebulization efficiency.
[0051] In certain embodiments, at least one nebulization efficiency parameter can be acquired during operation of the nebulization device. Additionally or alternatively, the nebulization efficiency parameter is also acquired during periods when the nebulization device is inactive, e.g., during expiratory phases or other operational breaks, such as when a medication container of the nebulization device is being replaced. In other words, the nebulization efficiency parameter can be determined for every time at which a nebulization effect occurs. As described above, the nebulization efficiency parameter is determined by acquiring at least two measurements at different times, with nebulization taking place between each measurement. The changes in various respiratory mechanics parameters are then calculated or displayed from these measurements.In special cases, the medication may only take effect once the nebulization phase has already ended.
[0052] In further embodiments, at least one nebulization efficiency parameter can be calculated and / or displayed essentially in real time. "Essentially in real time" here means that a barely perceptible offset for operating personnel between the actual and displayed value is tolerated, because this does not result in any disadvantage for the decision-making process.
[0053] 15045 P 4981 WO process of the operating personnel results. In any case, no perceptible delay results from the calculation and / or display time in the control or display device.
[0054] Some designs allow the history of at least one nebulization efficiency parameter to be stored in the control unit's memory. This serves, for example, to use a patient's past ventilation phases as a reference for future ones. If, for instance, a patient needs to be ventilated again within hours or days, previous values can help to restore stable ventilation, including effective drug delivery, more quickly. In chronically ventilated patients, previous values can serve as a starting point to accelerate adjustments. Experience from similar patient cases or established protocols can provide initial guidance for new ventilated patients.
[0055] In certain embodiments, the control unit can calculate and display a predicted trend for a nebulization efficiency parameter. A trend analysis over time can be determined by comparing this with previous ventilation settings. Stored ventilation logs or histories can show changes in lung condition, such as improvement in ARDS or deterioration in COPD. Alarm histories stored or documented in memory help to identify recurring problems. This allows individual alarm limits to be adjusted based on previous values. In certain embodiments, the control unit can also be configured to calculate and / or approximate derivatives of nebulization efficiency parameters.
[0056] In further embodiments, the control unit can be configured to output an electrical, optical, acoustic, or haptic signal, preferably on the display device. This signal can indicate a change in a nebulization efficiency parameter. Alarm systems in mechanical ventilation are essential for the early detection of critical changes in lung mechanical properties and for taking timely action. Electrical alarm signals include digital signals that can be sent to external monitoring systems, networks, or control units. This enables automatic integration into clinical monitoring systems through direct transmission to central monitors or remote monitoring, e.g., in intensive care units. Together with the recording and analysis of previous data, trend monitoring of pressure, compliance, and resistance becomes possible.
[0057] 15045 P 4981 WOAnalysis data can be combined with artificial intelligence (AI) and decision support systems, for example. Furthermore, electrical signals do not create noise pollution for operating personnel and can still be displayed. Visual alarm signals, such as LED indicators, color graphics in displays, or color-coded alarms, improve rapid recognition for staff, especially in noisy environments. Color coding allows for prioritization, e.g., traffic light colors (green = normal, yellow = warning, red = emergency). Visual alarm signals can be combined with other alarm systems, which enhances the perception of the warning signals. The effects of acoustic alarm signals, i.e., tones or voice announcements, are directly perceptible, even without visual contact. This can be particularly important for intensive care units with multiple patients.Furthermore, prioritization is possible due to different tones for varying levels of severity. Audible signals also increase reaction speed and can thus lead to the immediate attention of medical personnel. Mechanical vibrations or haptic / tactile feedback, e.g., via wristbands or smart devices, are particularly well-suited for individual alerts to nursing staff or doctors, as the signals can be discreetly transmitted to mobile devices (smartwatches, pagers). This is ideal in environments where audible alarms would be disruptive. This results in immediate, personalized notification, which is especially helpful for mobile care teams.
[0058] In some embodiments, the change in a nebulization efficiency parameter due to exceeding or falling below a threshold, a specific curve profile, a dynamic model, or the like can be calculated. The directly measurable lung-mechanical parameters can then be transformed through subsequent calculations and compared with fixed, stored, or recorded values and / or trends.
[0059] In a further aspect of the invention, a ventilation system is provided that is configured to perform the above-described method for assessing the effectiveness of drug delivery during patient ventilation. The ventilation system comprises a ventilator, a control unit, a nebulizer for drug delivery, and a display unit, all of which are interconnected. In particular, the control unit includes at least one computer system comprising processors, memory, communication units, and appropriate interfaces for its operation.
[0060] 15045 P 4981 WOEs It is pointed out that in this disclosure, when an element is described as "connected with" or "coupled with", or "electrically coupled with" another element, the element may be directly connected or coupled, or there may be intermediate elements.
[0061] The terms "memory" or "memory device," as used herein, refer to a non-volatile, computer-readable storage medium capable of storing program instructions, machine code, or programming code for execution by one or more processors. References to "memory" or "memory device" are to be understood as referring to one or more memories or storage devices. Memory may, for example, be multiple memories within the same system. However, memory may also be multiple memories distributed across multiple systems or computer devices.
[0062] A "controller" or "control device," as the term is used herein, is a computer-based device comprising hardware, software, and / or firmware for performing one or more of the process steps disclosed herein. References herein to a control device are to be construed as referring to one or more control devices. A control device may, for example, comprise one or more microcontrollers, or one or more microprocessors or processor cores. A control device may also refer to a collection of control devices or processors in a single system or be distributed across a plurality of computer systems. The term "computer" is to be interpreted, where possible, as referring to a collection or network of computers or computer devices, each comprising a processor or processors.Instructions from a computer program can be executed by a plurality of control units or processors, either located in the same computer or distributed across a plurality of computers.
[0063] Further advantages and features of the present invention are described below with reference to the accompanying drawings.
[0064] Fig. 1 is a schematic representation of a ventilation system designed to perform a procedure for assessing the effectiveness of drug delivery during ventilation of a patient.
[0065] 15045 P 4981 WOFig. 2 is a schematic representation of a display device of a ventilation system according to Fig. 1.
[0066] Fig. 3 is a schematic flowchart of an embodiment of the method for assessing the effectiveness of drug delivery during ventilation of a patient.
[0067] Figure 1 shows a ventilation system 1 configured to perform an embodiment of the inventive method for assessing the effectiveness of drug delivery during patient ventilation. The ventilation system 1 comprises a ventilator 2, a control unit 3, a nebulizer 4, a display unit 5, and a ventilation circuit 15, or breathing tube system with flexible tubes, which connects the ventilation system 1 to a patient 7. The ventilation circuit 15 comprises an inspiratory tube 6 and an expiratory tube 8, which are connected to each other at a Y-connector 9. The Y-connector 9 represents the patient interface to the patient 7. A tracheal tube is arranged at the third end of the Y-connector 9, through which respiratory gas is inspired into and exhaled from the patient's lungs.In the embodiment of the ventilation system 1 shown here, the inspiratory tube 6 is interrupted by the connection of a humidification unit 11. The humidification unit 11 serves to warm and humidify the breathing gas in order to protect the airways and prevent secretion retention and airway irritation. Furthermore, a filter 10 is arranged near the ventilator 2 at the end of the expiratory tube 8.
[0068] In the embodiment shown here, the display unit 5 is integrated into the ventilator 2, as is the control unit 3. In other embodiments, the display unit 5 may be part of another component of the ventilation system 1 or designed as a separate element. Similarly, the control unit 3 may also be designed as a separate element or be part of another component of the ventilation system 1.
[0069] The nebulizer 4 is located here in the first section of the inspiratory tube 6, close to the ventilator 2 and, in the direction of the breathing gas, shortly before the humidification unit 11. A mesh nebulizer or vibrating membrane nebulizer, consisting of a liquid medication or...
[0070] 15045 P 4981 WO generates fine liquid droplets, also called aerosols. Ultrasonic or jet nebulizers can also be used. Since the nebulizer 4 is communicatively coupled with the ventilator 2, the parameters for configuring the nebulizer 4 can be entered directly on the ventilator 2.
[0071] The ventilation system 1 is controlled via inputs and settings on the ventilator 2, in particular via the display unit 5, which is explained in more detail with reference to Fig. 2. In principle, it is possible to distribute the display and control elements of the ventilator 2 and the other components of the ventilation system 1 across several units. For reasons of practicality and time, it is preferable for medical personnel to control the entire ventilation system 1 from a single display and control unit, here integrated into the ventilator 2.
[0072] Fig. 2 shows an embodiment of a display device 5, as it may be configured in the ventilation system 1, which is set up to carry out the method according to the invention. The display device 5 comprises a display 12 on which at least one display element 13 and / or at least one control element 14 may be arranged. For example, the display 12 is a touch-sensitive display. Alternatively or additionally, the display device 5 may have other display or control elements such as buttons, sliders, rotary controls, LEDs, and the like. It is also possible that the display device 5 includes interfaces or connections for connecting to other input or output devices.
[0073] The ventilation modes and other ventilation parameters can be set on the display unit 5. Stored ventilation and patient data can also be selected and adjusted via corresponding selection elements, allowing an operator to control and monitor the entire ventilation process via the display unit 5 and, if necessary, forward recorded data. The control unit 3 is designed so that the control of the ventilation process and the forwarding of ventilation data can be carried out essentially automatically.
[0074] The display unit 5 is specifically designed to simultaneously and in real time show the nebulization efficiency parameters, in addition to the set data such as ventilation mode and other parameters. This allows the operating personnel to draw immediate conclusions about the effectiveness of the aerosol therapy based on the displayed data.
[0075] 15045 P 4981 WO or medication delivery, to relate to the patient's lung mechanical properties. For example, a traffic light-like display with the colors red, orange, and green can indicate the trend of a nebulization efficiency parameter. In conjunction with the display of the ventilation mode, medical personnel can deduce whether the selected ventilation strategy is still appropriate or needs to be changed or discontinued. The information displayed on the display unit 5 thus qualitatively illustrates how a given ventilation strategy actually affects the patient. Changes in nebulization efficiency parameters can also be visualized and compared, for example, with standard curves or historical trends during ventilation of the same patient.
[0076] Fig. 3 schematically shows a flowchart of the inventive method for assessing the effectiveness of drug delivery during patient ventilation. In step S1, the method begins with the proper provision and connection of all components of the ventilation system. Subsequently, in step S2, the ventilation mode is individually selected for the patient. Then, in step S3, the delivery of the drug in the nebulizer can begin. In step S4, the nebulization efficiency parameters are acquired by the control unit, optionally processed for display, and then shown on the display unit in step S5.
[0077] The invention provides a method for assessing the effectiveness of drug delivery during ventilation of a patient with a ventilation system, which visualizes the drug effectiveness during ventilation, reduces drug losses, indicates possible settings for better drug deposition in the lungs, and enables effective adjustment or control of ventilation derived from the specified parameters.
[0078] 15045 P 4981 WOList of reference marks:
[0079] 1 ventilation system
[0080] 2 ventilators
[0081] 3 Control unit
[0082] 4 Nebulizing device 5 Display device
[0083] 6 Inspiration hose
[0084] 7 patients
[0085] 8 Expiration tube 9 Y-piece
[0086] 10 filters
[0087] 11 Humidification unit 12 Display
[0088] 13 Display element
[0089] 14 Control element
[0090] 15. Ventilation circuit
[0091] 15045 P 4981 WO
Claims
Claims 1. A method for assessing the effectiveness of drug delivery by nebulization during ventilation of a patient (7) using a ventilation system (1), wherein the method comprises the following steps: Providing a ventilation system (1) comprising a ventilator (3), a control unit (3), a nebulizer (4) for drug delivery and a display unit (5) which are communicatively linked, Providing data from the ventilation system (1) during ventilation using a predefined ventilation mode; Providing data from the nebulizer (4) during ventilation; Determining a respiratory mechanical parameter at two points in time as a first and second measurement value, whereby nebulization takes place between the points in time; Determining a nebulization efficiency parameter by the control unit (3) based on the first and second measured values, wherein the nebulization efficiency parameter allows a statement about the influence of the drug delivery for the patient (7), and Displaying the nebulization efficiency parameter in the display device (5).
2. The method according to claim 1, characterized in that the ventilation mode is selected from the following group: Volume-controlled ventilation (VCV) Pressure-controlled ventilation (PCV) Pressure-assisted spontaneous breathing (PSV) Adaptive Support Ventilation (ASV) Bilevel ventilation (BiPAP) Lung recruitment maneuver. 15045 P 4981 WO3. Method according to claim 1 or 2, characterized in that the ventilation mode comprises ventilation parameters selected from the group comprising: Ventilation pressure Flow Respiratory rate Tidal volume Time for Inspiration (I) Expiry time (E) ratio of inspiration time to expiry time (l:E) Flow pattern (constant, decelerated, other patterns).
4. Method according to one of the preceding claims, characterized in that the respiratory mechanical parameter is selected from the following group: Lung compliance C, where: C = AV / AP with AV = change in tidal volume (in ml or L) and AP = change in pressure (in cm H2O or kPa) dynamic lung compliance Cd yn , where: Cdyn = V T / (P P eak - PEEP) with V T = Tidal volume (ml or L), Ppeak = Peak Inspiratory Pressure (PIP) PEEP = Positive end-expiratory pressure Static lung compliance Cstat, where: Cstat = V T / (Piat - PEEP) with Piate plateau pressure (measured after a short inspirational pause) Specific lung compliance C sp ec, where: C spec = Cstat / FRC FRC: functional residual capacity Airway resistance (R; Resistance) FRC: functional residual capacity Time constant r = R x C maximum flow rate V ma x Otis respiratory rate. 15045 P 4981 WO5. Method according to claim 4, when dependent on claim 2, characterized in that the time constant T is selected as the respiratory mechanical parameter and ASV is selected as the ventilation mode.
6. Method according to claim 4, when dependent on claim 2, characterized in that the Otis ventilation rate is selected as the respiratory mechanical parameter and ASV is selected as the ventilation mode.
7. Method according to claim 4, when dependent on claim 2, characterized in that lung compliance is selected as the respiratory mechanical parameter and the lung recruitment maneuver is selected as the ventilation mode.
8. Method according to claim 4, if dependent on claim 2, characterized in that a peak pressure (P) is used as the respiratory mechanical parameter. pea k) and the VCV mode is selected as the ventilation mode.
9. Method according to claim 4, if dependent on claim 2, characterized in that the maximum flow rate (V) is used as the respiratory mechanical parameter. max ) and the PCV mode is selected as the ventilation mode.
10. Method according to one of the preceding claims, characterized in that the at least one nebulization efficiency parameter is recorded and / or displayed essentially in real time.
11. Method according to one of the preceding claims, characterized in that the course of at least one nebulization efficiency parameter is recorded and / or displayed over a predetermined time period and / or an elapsed time period.
12. Method according to one of the preceding claims, characterized in that the course of at least one nebulization efficiency parameter is stored in a memory of the control device (3). 15045 P 4981 WO13. Method according to one of the preceding claims, characterized in that the control device (3) calculates a predicted course of a nebulization efficiency parameter and outputs it on the display device (5).
14. Method according to one of the preceding claims, characterized in that the control device (3) outputs an electrical, optical, acoustic or haptic signal preferably on the display device (5).
15. Method according to claim 14, characterized in that the signal indicates a change in a nebulization efficiency parameter.
16. Method according to claim 15, characterized in that the change of a nebulization efficiency parameter is calculated due to exceeding or falling below a threshold, a specific curve profile, a dynamic model or the like.
17. Ventilation system (1) configured to perform the method for assessing the effectiveness of drug delivery by nebulization during ventilation of a patient (7) according to any of the preceding claims. 15045 P 4981 WO