Expert Module for Ventilators and ECLS

Abstract

The present invention relates to an expert module for a ventilator, a corresponding ventilator and ECLS system, as well as a method for optimizing operating parameters within a complex medical system and for assisting a physician in determining which settings to make for the respective devices. Accordingly, an expert module (10) for a ventilator (12) of a patient (14) is proposed, the expert module (10) being designed to continuously receive at least one current vital parameter (16) of the patient (14), the expert module (10) comprising an evaluation unit (18). The evaluation unit (18) is designed to store the vital parameter (16) over a predetermined period of time, to determine a target value (20) for the vital parameter (16) based on a trend (22) of the vital parameter (16) and / or predetermined clinical information, and to determine a desired value (24A) for at least one operating parameter of the ventilator.

Description

[Technical Field]

[0001] The present invention relates to an expert module and method for a ventilator and an ECLS system for a patient, as well as a system comprising a ventilator, an ECLS system and a corresponding ventilator and ECLS system, with the aim of proposing optimized operating parameters thereof, in particular with respect to the patient's vital parameters. [Background technology]

[0002] In severe or advanced lung diseases such as ARDS, which involves severe lung injury and inadequate gas exchange, patients may need to be ventilated. This is especially true when the patient's own respiratory function is so insufficient that the patient can barely breathe. In such cases, breathing must be supported by a ventilator, or the patient must be artificially ventilated, for example, using an invasive mechanical ventilator. Such interventions may be performed not only on patients with lung disease, but also on patients with cardiac disease, or during surgery or treatment in which the patient is fully anesthetized or sedated and the patient's spontaneous breathing is artificially prevented.

[0003] In order to stabilize and improve the patient's condition in the long term, the operating parameters must be adapted to the patient's vital parameters. Operating parameters are subject to physiological extremes, and therefore cannot be set arbitrarily, but must be set taking into account potentially dangerous situations for the patient. For example, an excessively high respiratory volume can cause mechanical lung trauma, while a low respiratory volume can lead to, for example, acidosis. In clinical settings of care, e.g., in intensive care units, many important vital parameters and physiological factors must usually be taken into account, and therefore utmost care must be taken when selecting the operating parameter values to be set.

[0004] Therefore, ventilator settings must be adjusted regularly to the patient's condition and vital parameters, and ventilation must be constantly monitored to provide the patient with the best possible care and actually reduce the risk of adverse effects on the patient's health.

[0005] However, the high complexity of the large number of parameters and physiological interactions that are taken into account is difficult even for medical professionals to grasp, and therefore settings are made based on known clinical criteria that may often not provide optimal therapeutic support for the patient. The physician's judgment is therefore dependent on experience.

[0006] Treatment using mechanical ventilation may also be a contraindication to lung transplantation, particularly since such treatment increases morbidity, not least due to the risk of developing ventilator-induced infections, which therefore further contribute to the patient's condition. For patients undergoing life-sustaining lung transplantation, shortening mechanical ventilation and accelerating healing are, in any event, desirable.

[0007] When a patient's vital parameter values change significantly, it is difficult to adjust the operating parameter values in a way that does not exceed physiological limits or tolerances under any circumstances using conventional techniques. Rapid changes in vital parameter values and their effects therefore cannot be adequately taken into account using conventional techniques, especially in the case of long-term treatment requirements. In severe patient conditions, it is not uncommon for no ventilator setting to provide a sufficiently safe and effective treatment approach in clinical routine.

[0008] Thus, if improvement is not expected or if the pre-set operating mode based on clinical criteria is not acceptable for the patient's condition, the physician must decide how to proceed.

[0009] Extracorporeal membrane oxygenation can be used as an alternative to artificial ventilation of patients. In such a procedure, also known as ECMO ("extracorporeal membrane oxygenation"), the patient's respiratory function is taken over by an external medical device. Thus, the patient's pulmonary function or lung function or breathing is replaced by such a medical device, thereby ensuring blood oxygenation and especially carbon dioxide reduction for days or weeks, so that the lungs can rest and heal without external ventilation.

[0010] An ECMO system, also known as ECLS (Extracorporeal Life Support), can therefore be used as an extracorporeal life support system, equipped with a membrane oxygenator that functions as a gas exchanger for the patient's blood. Two blood vessels are cannulated, and blood is continuously pumped through the membrane oxygenator, which replaces the gas exchange within the lungs. Carbon dioxide is thus removed from the blood, and oxygen-rich blood is returned to the patient. Blood can be withdrawn, for example, from a venous access and returned through a venous or arterial access. Oxygenation is then achieved, for example, using veno-venous ECMO (VV-ECMO) or veno-arterial ECMO (VA-ECMO).

[0011] Due to the technical and personnel requirements for using ECMO, ECMO therapy is currently typically used in clinical practice only as an alternative to ventilation, and often only when ventilation does not sufficiently improve the patient's condition. However, it may occur that, when the critical threshold is exceeded, subsequent ECMO therapy is not sufficient to stabilize the patient's condition. The timely use of an ECLS system, such as a CMO system, can therefore be crucial to life support.

[0012] ECMO therapy parameters continue to be manually set by trained physicians or cardiac technicians. In making a therapeutic decision regarding whether to switch to ECMO therapy, medical personnel must therefore be able to manage or consider complex operational procedures and other treatment risks. Decision-making is also complicated by the complex interactions with and impact of target ECMO therapy on many physiological aspects. Therefore, it is currently very difficult for attending physicians to maintain a satisfactory balance between the patient's vital parameters, device operational parameters, and physiological conditions.

[0013] Therefore, there is a need to further improve ventilation parameters and adapt them to critical patient conditions in order to further improve the therapeutic effect and therefore the patient's health status and accelerate healing. Summary of the Invention [Problem to be solved by the invention]

[0014] Based on known prior art, one of the aims of the present invention is to enable continuous improvement of operating parameter values. [Means for solving the problem]

[0015] This object is solved by the independent claims. Advantageous embodiments can be derived from the dependent claims, the description and the figures.

[0016] Therefore, an expert module for a patient ventilator designed to continuously detect at least one current vital parameter of a patient is proposed. The expert module comprises an evaluation unit adapted to store the at least one vital parameter for a predetermined period of time, to determine a target value for the at least one vital parameter based on a course of the vital parameter and / or predetermined clinical data, and to determine a setpoint or setpoint value for at least one operating parameter of the ventilator based on the course of the at least one vital parameter and the target value of the vital parameter and in response to at least two physiological factors of the patient. Furthermore, the evaluation unit is adapted to determine a setpoint or setpoint value for at least one operating parameter of an ECLS system coupled to the patient based on the course of the vital parameter and the target value of the vital parameter and in response to the physiological factors. Finally, the evaluation unit is adapted to output a signal indicative of the setpoint or setpoint value for the operating parameter.

[0017] The automated determination of the setpoint or setpoint value provides the attending physician with decision-making assistance for determining the best possible settings for the ventilator in relation to the patient's condition. At the same time, the expert module according to the present invention enables therapeutic integration of the ECLS system, particularly the ECMO system or extracorporeal membrane oxygenator, thereby taking into account the effects of the membrane oxygenator on vital parameters and physiological factors. In this way, dual or simultaneous therapy approaches using ventilation and ECMO are enabled through their combination without further increasing the individual complexity of each of these therapies. Manual operation by medical staff, according to the prior art, reaches its limits in the case of such combined therapy. At the same time, the automated determination of the setpoint or setpoint value of the ECLS system according to the present invention allows for improved use of the ECMO system.

[0018] The setpoints or setpoint values can be determined at least periodically, preferably continuously, by continuously receiving or detecting the patient's vital parameter values, so that the operating parameter values can be adapted to the patient's condition at any time. Automatic setting of these values is also possible, but it is preferable to leave this to the physician. The evaluation unit then proposes the setpoints or setpoint values. However, the signal can be specified to contain an option or possibility to accept the setpoints or setpoint values, so that the corresponding operating parameter values can be automatically set after the physician accepts the proposed decision.

[0019] In this way, the present invention provides a decision aid to the physician by suggesting optimized values for at least one of the patient's most important vital parameters, ventilator settings, and operating parameters that take into account their effects or influences on the patient's most important physiological factors. As mentioned above, selecting ventilator settings is already a challenge for medical professionals. The selected decision may be favorable for one patient's physiological factors but contraindicated for another. The only support provided by existing prior art systems is the monitoring of vital and operating parameter values. For example, if the current value exceeds an acceptable range and becomes harmful or even threatening to the patient, an alarm function is triggered at that time. However, such monitoring is based only on snapshots, and therefore cannot be optimized in this manner. Therefore, prior art systems cannot take into account further effects or influences on the patient's condition or the evolution of the corresponding physiological factors.

[0020] In contrast, the present invention greatly simplifies therapeutic decision-making by automatically determining the set point or set point value and taking all of these factors into consideration, relieving medical staff of operational and monitoring duties and reducing the likelihood of setting errors.

[0021] At the same time, the present invention also facilitates medical decisions about whether to switch to extracorporeal membrane oxygenation or include it in emergency care, whereby preferred or optimized setpoints are automatically suggested by the evaluation unit. Because operation of ECMO systems is already challenging and can only be performed by specially trained personnel, the integration of such systems into treatment plans, even in combination with ventilation functions, is significantly simplified by the present invention and is now possible for the first time in many locations. Thus, the controllability of using an ECMO system simultaneously with ventilation ensures improved therapeutic efficacy and reduces patient morbidity through a faster healing process.

[0022] Alternatively, the automatically determined set point or set point value may indicate that it is preferable to continue ventilating the patient entirely with the ECLS system, without turning on the extracorporeal life support system or therapy. Thus, the set point decision may be made in stages, whereby use of the therapy system is first entered or confirmed, and the set point or set point value is then (re)determined and adopted as needed. For example, a physician may manually activate the ECLS system. The evaluation unit automatically recalculates the set points or set point values for the ventilator and ECLS system.

[0023] Decision support for the physician is provided by outputting a signal, whereby the signal corresponds to a particular set point or set point value. In other words, the signal can be an indicator of a proposed decrease or increase in a given operating parameter value using, for example, optical and / or acoustic indicators. For example, the face of the expert module can be provided with one or more LEDs that, by their color or positioning, indicate a corresponding change in the respective operating parameter value.

[0024] The setpoint or setpoint value is preferably determined by a physiological model stored in the evaluation unit and accepting the patient's vital parameter values. The physiological model can determine target values a priori. Thus, the model is not only based on snapshots but also includes the course or evolution and fluctuation of the vital parameters. Clinical guideline values for the respective patient's clinical situation are prioritized. Furthermore, the effect or influence of the operating parameter values on at least two physiological factors of the patient is taken into account. For example, correlations can be established using previously collected patient data stored in a database, i.e., from a patient population with comparable clinical situation and vital parameter values, and / or by comparison with serial examinations and laboratory values. For example, learning algorithms can be used that also take into account the patient's specific disease course.

[0025] For patient treatment, different gas mixtures can be delivered as breathing gas, so that besides air of neutral composition, for example, oxygen, nitrous oxide, helium, carbon monoxide enriched medical gas mixtures, and / or one or more nebulized medications can be delivered. The physiological model may be able to take into account the effect or influence of the composition of the medical gas mixture on physiological factors and vital parameters, or conversely, make recommendations regarding the appropriate selection of the gas mixture to be delivered.

[0026] The expert module, which functions as decision support and can be configured as a monitor module for at least one vital parameter and / or operating parameter value, is a modular unit that can be implemented, for example, in a ventilator or ECMO console or communicatively coupled to the ventilator or ECMO console as a separate unit. Similarly, the expert module can be provided to be communicatively coupled to a monitor or external device, such as a medical staff member's portable, preferably wireless, device and / or a central monitoring system. Vital parameters, particularly operating parameter values of multiple ventilators and / or ECLS systems, can be easily further monitored externally, for example, using an integrated communications module. Such communications modules can be provided to provide non-personalized data, such as received vital parameters and calculated setpoints or setpoint values, to a central physiology learning module to enable expansion of the data set and improvement of the physiological model. Such data can be transmitted and / or stored, for example, through a server or cloud, and processed as needed.

[0027] The expert module is also preferably adapted to receive actual values of the operating parameters from the ventilator and ECLS system, whereby the evaluation unit is adapted to determine set points or set point values as a function of the actual values. In this manner, it can be evaluated whether preferred settings match current settings or whether operating set points or operating parameter values should be adjusted to optimize therapy. Feedback is thereby provided to the extent that proposed operating parameter values are adopted, whereby the expert module can also examine whether calculated or modeled effects or influences on physiological factors and / or vital parameters are appropriately displayed.

[0028] The actual values are preferably received continuously through an interface. When the expert module is implemented in a ventilator or ECLS system, one or more vital parameters may be received through such an interface, for example through a communication connection with an external measurement device or through a communication connection with an integrated measurement device of the ventilator or ECLS system.

[0029] Ventilators can be configured to support a patient's spontaneous breathing or to provide ventilation to the patient. After invasive access to the airway, a mechanical ventilator can assist breathing or replace the patient's breathing, as needed, for example, via endotracheal intubation or tracheotomy. In intensive care units, such procedures are performed in approximately 10-15% of patients with ARDS. However, it is known that only approximately 20% of these patients actually require such treatment.

[0030] The operating mode of the ventilator may depend on the patient's condition, but the ventilator can be supportive, allowing, for example, weaning or observation. Switching the ventilator to a comprehensive operating mode provides complete ventilation. In this operating mode, the ventilator alone breathes when the patient has no or very little spontaneous breathing. In principle, the patient is sedated so that spontaneous breathing is no longer necessary. However, since excessive or prolonged sedation poses risks, the target dose is usually set to keep the patient as awake as possible, but does not eliminate the patient's spontaneous breathing.

[0031] In severe indications such as ARDS, the administration of such sedatives is often not possible. Nevertheless, efforts should be made to reduce the duration of ventilation as much as possible. Combining ventilation according to the present invention with ECLS or ECMO therapy allows for a suitable approach. By suggesting the best treatment for the patient, the patient's condition and healing can be improved, achieving the fundamental goal of shortening the treatment period. The expert module or evaluation unit can support the decision-making process of whether a combined therapy with the aid of a ventilator and, for example, an ECMO system is required, or whether a monotherapy using an ECMO system or a ventilator alone, respectively, can provide a more promising outcome. Regarding treatment, support is provided for selecting the operating parameters of the ECMO system and / or the ventilator. In the case of an ECMO system, the operating parameters concern in particular the blood flow setpoint (in the form of a rate setting or l / min specification) and the gas flow setpoint (l / min) for the gas exchanger. The operating parameters of the ventilator to be set can be, for example, the inspiratory pressure, the inspiratory time, and the expiratory time.

[0032] Preferably, the expert module is coupled to the monitor, whereby the signal output includes a graphical representation or display of the setpoint or setpoint value, actual value, target value, and / or corresponding value progression. For example, the monitor can be a ventilation system or ventilator monitor or user interface, whereby the expert module is coupled to or implemented within the ventilator. Alternatively, the expert module can be implemented as a separate modular unit or in an ECMO console with the monitor. By displaying the preferred setpoint or setpoint value, medical personnel can immediately determine which ventilator operating parameter values can or will be modified to stabilize or improve the patient's condition.

[0033] By displaying the actual value, a comparison with the current settings is also possible, allowing staff or physicians to immediately recognize any deviations of the proposed setpoint or setpoint values from the current actual value. For example, if the deviation is very small, the physician can determine whether minor adjustments are necessary, or conversely, whether no further adjustments are necessary. On the other hand, if the deviation is large, the physician may need to reexamine the patient's condition, particularly the settings and functionality of the ventilator and ECLS system.

[0034] Finally, the display of target values offers the possibility to illustrate the effect or influence on vital parameters, whereby the target values can be modified or manually entered if necessary. The presentation of the disease course provides yet another decision aid, allowing the physician to get an overall picture of the disease course or patient condition and to intervene by adjusting the suggested set points or set point values, if appropriate, in the event of deterioration or lack of improvement.

[0035] The evaluation unit preferably determines the setpoint or setpoint value from a physiological model stored in the evaluation unit, and the signal may include a graphical representation of the effect of the setpoint or setpoint value on the physiological factor modeled by the evaluation unit. The physiological model described above can predict an effect or influence on the physiological factor using an evaluation function, e.g., by selecting a scale between a negative and a positive range, or by using any other evaluation technique. For example, an adverse effect can be represented by a negative value, a neutral or stable effect by a value near zero, and a prognosis of an improvement in the patient's condition by a positive value. Alternatively or additionally, such evaluation can further use a (graphical) representation to represent, for example, opposing physiological factors (i.e., a predicted improvement of one physiological factor accompanied by a simultaneous predicted deterioration of another physiological factor). For example, when more than two physiological factors are considered, a polygon can be mapped, whose peripheral region corresponds to an adverse effect and whose central region corresponds to a predicted positive effect. Different predicted influences can be represented as points within the polygon. If necessary, the points can be combined into a polygon to facilitate and simplify interpretation by the physician.

[0036] As mentioned above, each physiological factor may evolve differently from the others, so that, for example, adjusting an operating parameter value may slightly improve one factor while pushing another factor into a critical range. These evolutions of the individual factors can also be taken into account in the graphic representation, so that, thanks to the present invention, the physician no longer has to mentally deal with the resulting complex relationships of many variables, thereby facilitating decision-making. In contrast to displaying relevant parameters on different devices and issuing alarm signals in the event of deviations from individual values, thanks to the present invention, all decision-relevant data can therefore be advantageously viewed directly on the central monitor and visible in the context of the patient's pathological condition.

[0037] It may be preferable to display the effects of setpoints separately for the ventilator and the ECLS system. In addition to the predicted effect of setpoints or setpoint values, a graphical representation of the modeled effect of actual values on physiological factors, for example, may be provided. Such graphical representations, e.g., using polygons, allow a physician or medical personnel to immediately recognize which factors are expected to improve, particularly by comparing the actual condition with the calculated and / or suggested condition. Furthermore, a display of the actual condition without the ECLS system and the proposed condition after the ECLS system is used allows a physician to immediately recognize, for example, the expected effect of gas exchanger function on the patient's condition. Displaying setpoints or setpoint values for an ECLS system can simplify implementation and make physician decisions easier.

[0038] The physiological factors include different patient-related factors, meaning that the patient-related factors are generally not ventilator operating parameters, but are primarily related to the patient's pulmonary function, respiratory system, and / or cardiovascular system. Thus, the physiological factors are primarily indicative of hyperventilation or ventilatory failure. In particular, the physiological factors can be selected from the group including mechanical lung trauma, atrophy, barotrauma, volutrauma, alkalosis, oxygen toxicity, resorptive pulmonary hypodiastole, acidosis, hypoxia, stress, and hemodynamic side effects. In one embodiment, none of the at least two physiological factors is the patient's blood pressure. According to the present invention, one or more of these physiological factors can be represented.

[0039] For example, one or more operating parameters can be optimized to reduce respiratory volume and peak inspiratory airway pressure to prevent lung trauma. Meanwhile, the need to avoid acidosis requires only small adjustments to ventilation pressure without increasing the risk of developing lung trauma. The calculated effects on physiological factors can be continuously improved in their prognostic reliability, if necessary, by feedback and corresponding calculations using current vital parameters received from the patient. It can be optional for the expert module or evaluation unit to request measurement of at least one additional vital parameter to improve the results of the feedback optimization.

[0040] Since a patient's condition is typically characterized by many vital parameters, which are associated with a correspondingly large number of physiological factors, the evaluation unit is adapted to determine the set point or the set point value depending preferentially on 3 or more, preferably 5 or 6 physiological factors. Priority should be given to at least one factor from the group: mechanical lung trauma, atrophy, oxygen toxicity, acidosis, hypoxia or hypoxia saturation, and / or stress.

[0041] As mentioned above, the physiological factors influence each other, so that an improvement in one factor may cause a deterioration in another factor, and therefore the evaluation unit is preferably adapted to determine the setpoint or setpoint value using a physiological model stored in the evaluation unit in such a way that the negative impact on all physiological factors considered is minimized and / or that the physiological factors are not exceeded in any case after correction to their respective specified or predetermined tolerances.

[0042] Although optimal conditions for all of the individual factors may not be achieved, it is routinely observed that the set point or set point value improves vital parameters and physiological factors without exceeding the tolerance range of each individual factor. Thus, although the effect on one factor may not be very therapeutically useful, such a situation may be acceptable on an individual and case-by-case basis in view of the overall improvement obtained (due to the improvement of other factors). Similarly, one or more factors may be targeted for improvement, but the evaluation unit should preferably determine the set point or set point value so that it does not lead to exceeding the tolerance range of other factors.

[0043] Additionally, physiological factors may be weighted differently depending on the patient's condition or preferred treatment, allowing special consideration to be given to one or more factors when determining the set point or set point value. The present invention still allows for the (proposed) operation of an ECLS system to supplement treatment, particularly in critical patient conditions, thereby avoiding ventilation parameters and conditions that, if not used, could in turn endanger the patient. Switching to an ECLS system is also possible, since turning on the ECLS system allows ventilation to be reduced or turned off, if desired.

[0044] The weightings can also be variable so that the physician can adapt the physiological model to the treatment method and the patient. In further embodiments of the invention, it can be provided that the physician can manually modify points in the graphical representation, so that the physiological model or the evaluation unit determines the setpoints or setpoint values that are required and, if necessary, indicates whether the setpoints or setpoint values exceed physiological limit conditions. This allows the physician to compare different options and the effects of any deviations from the proposed setpoints or setpoint values, thus providing further support in the physician's decision-making process.

[0045] For example, if the expert module is implemented in a ventilator or can be coupled to other external devices, the vital parameters can be provided directly by a measurement device communicatively coupled to the expert module and received by the evaluation unit. Thus, the at least one vital parameter is preferably selected from the list comprising pulse oximetry oxygen saturation, exhaled oxygen fraction, exhaled carbon dioxide fraction, oxygen uptake function, carbon dioxide output, and blood pH.

[0046] In order to increase the accuracy of the setpoint or setpoint value determined, the expert module is preferably adapted to receive at least two vital parameters, preferably at least three or four vital parameters.

[0047] Furthermore, the at least one operating parameter of the ventilator preferably includes a tidal volume, a peak inspiratory pressure, a positive end-expiratory pressure, a breathing frequency, an inspired oxygen fraction, an inspired carbon dioxide fraction, and / or a ratio between inspiration duration and expiration duration. Furthermore, the at least one operating parameter of the ECLS system preferably includes a blood pump flow rate, a gas volumetric flow rate, and / or a system pressure.

[0048] Positive end-expiratory pressure (PEEP), also known as "positive end-expiratory pressure," helps counteract the decline in functional residual capacity and alveolar collapse, i.e., the formation of asystole. Increased PEEP can have adverse effects due to overstretching of the ventilated lung area, reduced cardiac output, and / or increased intercranial pressure. Nevertheless, increasing PEEP can reduce mortality, especially in ARDS patients. In the prior art, protocols for setting pressures are always established. However, these charts do not take into account different individual respiratory mechanics and therefore only provide unreliable decision-making aids for the treating physician. However, the evaluation unit used by the present invention takes into account not only the expected effects of different physiological factors but also the use effects of the combined ECLS system, so that the proposed set point or set point value can take into account the entire system with its many variables.

[0049] Additionally, the fraction of inspired oxygen (FiO2) can be adjusted to prevent hypoxia in the patient, which must generally be limited to avoid, for example, oxygen toxicity. For example, the oxygen fraction can be adjusted to achieve an arterial oxygen saturation of about 80-95% or an arterial oxygen partial pressure of about 50-90 mmHg.

[0050] Too high a tidal volume can cause lung trauma due to hyperstretching, so for example, in ARDS patients, the tidal volume is preferably set at 6 mL / kg or less of the patient's body weight, but in patients without ARDS, this can be increased to 8 mL / kg of the patient's body weight.

[0051] Additionally, to avoid barotrauma, for example, peak inspiratory pressure can be adjusted to preferably be less than 30 cmH2O.

[0052] To best support medical professionals in setting different ventilator and / or ECLS system settings, the evaluation unit is preferentially configured to determine set points or set point values for two, three, or four ventilator operating parameters and set points or set point values for two ECLS system operating parameters. The set points or set point values for inspired oxygen fraction, tidal volume, positive end-expiratory pressure, and respiratory rate preferably suggest optimized setting values to the physician that directly affect physiological factors.

[0053] The evaluation unit is also preferably adapted to determine a set point or set point value depending on the ratio of (i) ventilator support to (ii) ECLS support in terms of vital signs, whereby the ratio is determined by the evaluation unit. For example, if breathing is to be supported approximately 70 percent by the ECLS system and approximately 30 percent by the ventilator, the set point or set point value may cause the ECLS system to deliver approximately 70 percent of maximum oxygen uptake.

[0054] With adjustment of the setpoint or setpoint value and / or modification of the support rate of the ventilator and ECLS system, it also becomes reasonable to measure certain vital parameters to allow adequate monitoring and continuous optimization of the setpoint or setpoint value. Thus, the signal can be defined to continue to include a request to receive another, preferably certain, vital parameter.

[0055] The evaluation unit can also be adapted to compare the course of the vital parameter with a tolerance range and / or a modeled course and to output a signal with an alarm function if a deviation of the vital parameter beyond a predetermined threshold or limit value is detected. Instead of outputting an alarm signal immediately when the current actual value is exceeded, the alarm signal is only output if there is an overall negative trend in the patient's condition.

[0056] Therefore, adjustment of operating parameter values is only necessary if the patient's overall condition becomes unstable. For example, peak values of vital signs may exceed acceptable limits, but may return to normal within a short period of time, thereby not requiring adjustment of the corresponding operating parameter values. Thus, the present invention enables intelligent monitoring of patients, greatly limiting time-consuming control by the physician while even suggesting corresponding specific set points or set point values for operating parameters to improve the patient's condition.

[0057] The above-mentioned object is further solved by a ventilator, preferably a mechanical ventilator, including the expert module of the present invention, which is thus capable of providing invasive or non-invasive ventilation to a patient to support or artificially replace breathing, the degree of support being variable during treatment.

[0058] In this case, the expert module is preferably integrated into the ventilator, so that the monitor of the expert module can be designed, for example, as a user interface of the ventilator. Furthermore, an interface for receiving vital parameters can be provided and / or the ventilator can comprise a device communicatively coupled to the expert module for recording at least one vital parameter of the patient.

[0059] The above-mentioned objects are still solved by an ECLS system including an expert module of the present invention. The ECLS system is preferably an ECMO system. Thus, the ECLS system can provide extracorporeal membrane oxygenation for a patient's blood, and pulmonary function or breathing is assisted or artificially replaced by the ECLS system. The ECLS system can include a console having a monitor, the monitor adapted to map signals.

[0060] Furthermore, a system including a ventilator and an ECLS system is proposed. Thus, the components of the expert module, the ventilator, and the ECLS system can be adapted to each other so that redundancy is largely eliminated, allowing the system to be designed more compactly. This also allows for direct control of both the ventilator and the ECLS system. A central communication interface can be provided, whereby the relevant components of the system of the present invention can be regulated and adapted by the expert module.

[0061] The above-mentioned object is further solved by a method for monitoring vital parameters (16) of a patient (14), said method comprising at least the following steps: - continuously receiving from the expert module at least one current vital parameter of the patient; - storing at least one vital sign in an expert module for a predetermined period of time; - determining, in an expert module, a target value for at least one vital parameter based on the course of the at least one vital parameter and / or predetermined clinical data, - determining, in an expert module, a set point or a set point value of at least one operating parameter of the ventilator provided to the patient, the set point or the set point value being determined based on the course of at least one vital parameter and a target value of the at least one vital parameter and in response to at least two physiological factors of the patient; - determining, in the expert module, a set point or set point value for at least one operating parameter of the ECLS system to be provided to the patient, the set point or set point value being determined based on a history of at least one vital parameter and a target value of the at least one vital parameter and in response to physiological factors; and - outputting, by the expert module, a signal characterizing the setpoint of the operating parameter.

[0062] The method can be implemented and executed in an expert module, whereby the individual steps are preferably executed by an evaluation unit integrated in the expert module. The method serves as a decision aid for the physician to enable the most advantageous and best treatment for the patient.

[0063] In particular, the method may be advantageous for patients with respiratory failure, whereby the method supports the physician when weighing the medical device or system to be used.

[0064] Preferably, the signals may represent usage suggestions for a ventilator and / or an ECLS system, such as an ECMO system. Thus, whether a medical device should be used or turned on, or whether a different medical device should be switched on, can be initially specified as needed. The signals may then or simultaneously indicate specific operating parameter values for the device or system to assist the clinician in setting and / or adjusting the settings, optimizing the operating parameter values to improve physiological factors and / or vital signs. Thus, the signals and set points or set point values are modeled values, whereby many factors and variables are considered, and these are suggested to the physician to facilitate therapeutic decisions and delegation or adjustment of the set points.

[0065] This significantly facilitates integration with another or alternative medical device or system, thereby allowing decision support to be implemented in an appropriate phased manner. Furthermore, since the setpoint or setpoint value is also determined based on at least one received vital parameter, fluctuating or changing values are contemplated when determining the setpoint or setpoint value. Preferably, the target value and / or setpoint or setpoint value is determined continuously or periodically.

[0066] It is also possible that after manual setting of the operating parameter values, the expert module again determines the target values and / or set points or set point values. Thus, a feedback or feedback loop is provided, whereby the method may provide that the effect of the setting on the physiological factor and / or at least one vital parameter is fed to a physiological model or learning algorithm, if desired.

[0067] To indicate to the physician whether further optimization of the operating parameter values or the medical device or system used for treatment is possible, the expert module can continue to receive actual values of the operating parameters from the ventilator and / or ECLS system, whereby the setpoint or setpoint value is determined as a function of the actual value. A comparison is then made between the actual disease state and the calculated setpoint disease state, whereby a signal indicates whether further therapeutic improvements are possible based on the theoretically calculated effects on physiological factors.

[0068] While such signals may be output in the form of one or more LEDs, for example, as indicators suggesting a decrease or increase in a particular operating parameter value, a more detailed or specific visual display of the set point or set point value often facilitates a physician's decision, for example, allowing comparison to standard or guideline-compliant operating parameter values. Thus, the signals are preferably output as a graphical representation of the set point or set point value, actual value, target value, and / or corresponding value progression on a monitor communicatively coupled to the expert module.

[0069] The setpoint or setpoint value may be determined using a physiological model stored in the expert module, whereby the signal may include a graphical representation of the effect or influence of the setpoint or setpoint value on the physiological factors modeled by the expert module. More preferably, the effects are replicated separately for the ventilator and ECLS system, and / or the signal includes a graphical replication of the modeled effect of the actual value on the physiological factors in addition to the effect of the setpoint or setpoint value.

[0070] As described above, the physiological model can predict effects on physiological factors using an evaluation function, whereby, for example, adverse effects can be characterized by negative values, neutral or stable effects by values near zero, and prognoses that improve the patient's condition by positive values.

[0071] It can therefore be provided that the set points or set point values are determined using physiological models stored in the expert module in such a way that adverse effects on physiological factors are minimized and / or that physiological factors do not exceed predetermined tolerances.

[0072] For example, a physiological factor may be characteristic of hyperventilation or ventilatory failure. Thus, conflicting physiological factors may be considered when determining a set point or set point value; i.e., a predicted improvement in one physiological factor may simultaneously result in a predicted deterioration in another physiological factor. Such conflicting effects may be depicted graphically, if desired. For example, if more than two physiological factors are considered, a polygon may be depicted, with its peripheral regions corresponding to adverse effects and its central region corresponding to predicted positive effects, with each corner corresponding to a physiological factor, and each predicted effect represented as a point on the polygon. To facilitate and simplify interpretation by the physician, the points may be joined into a polygon, if desired. Thus, the effect of a proposed set point or set point value on each physiological factor is simplified and visible at a glance.

[0073] If the signal indicates that a combination of ventilator and ECLS system, e.g., ECMO system, therapy is recommended, the method may further provide that the set point or set point value is determined as a function of the ratio of the ventilator support intensity to the ECLS system support intensity for at least one vital parameter determined by the expert module.

[0074] The signal may also include a request to receive at least one other, preferably specific, vital parameter. For example, a specific blood value may need to be measured and provided to enable the ECMO system, and / or it may be advantageous for the calculated proposed set point or set point value to take into account the additional vital sign, in order to further optimize the set point or set point value relative to a physiological factor using at least one additional vital sign.

[0075] Furthermore, the course of the vital parameters is preferably compared with tolerances and / or modeled courses in the expert module, whereby an alarm signal is sent when a deviation of the vital parameters beyond a predetermined threshold or limit is detected. Alternatively or additionally, the expert module can send an alarm signal when a manual setting of an operating parameter value exceeds a specified or predetermined threshold or limit of the modeled effect on the operating parameter value, at least one vital parameter, and / or physiological factors. Thus, a physician can become aware of systematic errors and / or physiologically serious pathologies as early as possible, or potential physiological risks can be indicated when manual adjustments may put the patient at risk.

[0076] The method is preferably implemented using an expert module according to the present invention, although it is not limited to the expert module according to the present invention. Similarly, various aspects of the expert module described above can be implemented in the method without limiting the method to the structural design of the expert module, unless already explicitly described with respect to the method.

[0077] The following description of the figures explains preferred embodiments of the invention in more detail. [Brief explanation of the drawings]

[0078] [Figure 1] FIG. 1 is a schematic diagram of an expert module implementation at a logical level. [Figure 2] FIG. 1 is a schematic diagram of a physiological model stored in the evaluation unit. [Figure 3A] FIG. 10 illustrates an alternative design of a system having an expert module with a communicatively coupled ventilator and ECLS system. [Figure 3B] FIG. 10 illustrates an alternative design of a system having an expert module with a communicatively coupled ventilator and ECLS system. [Figure 3C] FIG. 10 illustrates an alternative design of a system having an expert module with a communicatively coupled ventilator and ECLS system. [Figure 4A] FIG. 1 illustrates the history / progression of ventilator and ECLS system operating parameters, vital sign values, and suggested specific set points or set point values. [Figure 4B] FIG. 1 illustrates the history / progression of ventilator and ECLS system operating parameters, vital sign values, and suggested specific set points or set point values. DETAILED DESCRIPTION OF THE INVENTION

[0079] In the following, preferred embodiments will be described with reference to the drawings, in which the same, similar or equivalent elements in different drawings will be provided with the same reference numerals, and repeated descriptions of these elements will be omitted to avoid redundancy.

[0080] FIG. 1 shows a schematic representation of an expert module 10 for a patient's ventilation, which is essentially implemented at the logical level, as indicated by the dashed lines. It is thus a logic unit executable, for example, by a microprocessor provided in the expert module 10 and stored in a corresponding memory. At least one vital parameter 16 is received as input signal for this logic unit through a hidden interface from an evaluation unit 18 present in the expert module 10. The evaluation unit 18 forms a central component and can be integrated as a hardware and / or program module within the expert module 10. For example, the evaluation unit 18 can be implemented as part of the control unit of the expert module 10, if the expert module 10 is designed as part of a ventilator and / or as a controller for the ventilator, as required. However, it can also be provided that the expert module 10 is designed as part of an ECLS system or as a separate unit communicatively coupled to an ECLS system, such as a ventilator and / or an ECMO system.

[0081] The evaluation unit 18 processes the at least one vital parameter 16, as indicated by the corresponding arrow, and determines a target value 20, for example, based on clinical criteria. Furthermore, since the vital parameter 16 is continuously received and stored, a progression 22 of the vital parameter 16 can be taken into account when determining the target value 20. Based on the progression 22 and the target value 20, a set point or set point value 24A is predicted for the operating parameters of the ventilator that will improve the patient's physiological condition. In determining this value, the effect or influence of the set point or set point value on at least two physiological factors 26A, 26B is also taken into account, so that when optimizing the respective operating parameter and the at least one physiological factor 26A, 26B, possible adverse effects or influences on another physiological factor 26A, 26B are minimized, as will be explained below with reference to FIG. 2.

[0082] For example, the current maximal oxygen uptake of a patient can be measured as a vital parameter 16. This parameter can be improved by increasing the respiratory volume. However, increasing the respiratory volume may also pose a risk of mechanical lung trauma as a result of hyperextension. To avoid or reduce this potential negative effect, for example, the operating parameter value for respiratory volume can only be increased up to the tolerable limits for other physiological factors. Any risk to the patient is thereby largely eliminated a priori.

[0083] Furthermore, the expert module 10 can be coupled to an ECMO system (not shown) with an extracorporeal membrane oxygenator and include a console, so that such a system can be tailored not only to the patient's specific clinical situation and critical patient condition, but also to improve physiological factors 26A, 26B in general. Operating an ECLS or ECMO system is already challenging for operational staff. However, when connecting to parallel ventilation, additional operational parameters of the ECMO system must be considered in addition to the vital parameters 16 and the ventilator's operating parameters. This likely represents a significant barrier to entry for even qualified medical professionals when using membrane oxygenator or ECMO and ventilation combination therapy. Therefore, operational staff must first decide whether to implement parallel ECMO and ventilator therapy at all, or whether to implement ventilation alone or ECMO alone. For example, it may be stipulated that an ECMO system with an extracorporeal membrane oxygenator be used as a replacement for patient ventilation, i.e., the ventilator can be subsequently turned off. However, operational parameters must be determined taking into account the physiological factors for each therapy.

[0084] However, the expert module 10 also considers coupled ECLS systems, e.g., ECMO systems, whereby all control parameters for the ECMO system or ECMO therapy are centralized in the ECMO console. This also makes it possible to determine at least one setpoint 24B of the ECLS system, such as the blood flow for the blood pump and / or the gas flow for the gas mixer, in addition to the ventilator. This is made possible by a physiological model 32, shown in dashed lines.

[0085] Thus, evaluation unit 18 determines at least one setpoint 24A for the ventilator as well as at least one setpoint 24B for the ECLS system. These setpoints or setpoint values 24A, 24B can be transmitted to a physician or medical staff using corresponding signals 30, for example, as a graphical representation of the setpoints or setpoint values 24A, 24B for the respective operating parameters. In accordance with the present invention, this provides suitable decision support for the physician so that therapeutically prudent settings for the ventilator and ECLS system are easier or even possible, even with many variables and factors to consider.

[0086] FIG. 2 illustrates a schematic representation of the physiological model 32. As described above, a history is recorded from the received vital parameters 16, and a corresponding target value 20 is determined. Preferred settings for the ventilator and ECLS system are then calculated from the target value 20 and the history or history (not shown), thus determining corresponding set points or set point values 24A and 24B. For each set point or set point value 24A, 24B, an effect on at least one physiological factor 26A is calculated or modeled, whereby the effect is preferably based on an assessment on a scale. For example, the scale may include a minimum negative value and a maximum positive value, with a neutral effect, i.e., zero, representing neither a worsening nor an improvement in the physiological factor.

[0087] The physiological model 32 also provides that after determining the (maximum) positive effect on one physiological factor 26A, the effect on at least one other physiological factor 26B is calculated, simulated, or modeled, as indicated by the corresponding arrow. If the predicted effect is negative, e.g., beyond an acceptable range, the set points or set point values 24A, 24B are again determined. Adjustment of the set points or set point values 24A, 24B takes into account the effect on the other physiological factor 26B to fall within an acceptable range. Because physiological factors 26 may be interdependent, it may be provided that only one of the physiological factors 26A, 26B can be improved by the corresponding set point or set point value 24A, 24B, thereby necessitating the acceptance of a slight improvement, stabilization, or even slight deterioration of the other physiological factor 26A, 26B.

[0088] This process is preferably iterative. Nominal values 24A, 24B are input continuously and dynamically. The effect or influence on the physiological factors 26A, 26B is used as feedback. For example, a first set point or set point value 24A may have a positive effect on the physiological factor 26A (e.g., a rating of 5 on a scale of -10 to 10), while this selection may have a negative effect on another physiological factor 26B, e.g., a rating of -4. It is also possible to prevent this negative value from exceeding the acceptable range. However, in a second iteration, the set point or set point value 24A is reduced, e.g., by 20%, thereby resulting in a slight reduction of the first physiological factor 26A to 4, while achieving an improvement of the other physiological factor to 0. The effect or influence on the physiological factors 26A, 26B can be linear or nonlinear in nature. In this way, this set point or set point value 24A can result in an overall improvement of the patient's physiological condition.

[0089] However, a third iteration involving further adjustment or reduction of the set point or set point value 24A may improve both the first physiological factor 26A and another physiological factor 26B, shortening the patient's recovery process in the long term. However, the present invention preferably requires the physician to manually set the settings, but instead of providing automatic settings, only suggests set points 24A, 24B to aid in setting decision-making. Thus, for example, the physician may adopt or deviate from set points or set point values 24A, 24B to specifically improve a particular physiological factor 26A, 26B, for example, in the event of an acute deterioration of such factor. Thus, the physician may only monitor a small number of operating parameters and factors and be further aided by the suggested set points 24A, 24B when setting or adjusting both the ventilator and the ECLS system. However, the present invention allows for full automation of the setting procedure, albeit primarily without notification.

[0090] FIG. 3A illustrates a system having an expert module 10 implemented in a ventilator 12 and an extracorporeal membrane oxygenator 28 coupled thereto, whereby a patient 14 is simultaneously treated by the ventilator 12 and the ECLS system 28. However, as noted above, this configuration is optional, and it is possible to provide that the expert module 10 is designed into the ECLS system 12 or as a separate unit that can be coupled to the ventilator 12 and the ECLS system 28. For example, the ventilator 12 can be a mechanical ventilator invasively coupled to the patient's airway via endotracheal intubation. The ECLS system 28 can be, for example, an ECMO system that can be connected to the patient's blood circulation using two cannulas, whereby, for example, blood is withdrawn from venous access and returned through venous or arterial access. Extracorporeally, blood is continuously pumped through the membrane oxygenator, which replaces gas exchange in the lungs, so that carbon dioxide is removed from the blood and oxygen-rich blood is returned to the patient. As indicated by the corresponding arrows, the patient 14 is treated simultaneously using both the ventilator 12 and the ECMO system 28 .

[0091] The expert module 10 in this version is integrated into the ventilator 12. However, it can be provided that the expert module 10 is designed as a separate or external device or is integrated into another device. The expert module 10 receives at least one vital parameter 16 of the patient 14, as described above, so that an evaluation unit (not shown) can prognostically determine and suggest set points or set point values for both the ventilator 12 and the ECLS system 28, for example using a physiological model, in order to improve the physiological condition of the patient 14. These set points or set point values are output using corresponding signals 30 present on the monitor 34, thereby allowing a graphical representation of the actual values 36A, 36B received by the ECMO system 28 and the ventilator 12, together with the set points or set point values present on the signals 30.

[0092] The monitor 34 may also be displayed as an external unit if desired, but may also be integrated into the ventilator 12 or into the console of the ECLS or ECMO system 28, for example, as part of a user interface. The monitor 34, optionally designed as a user interface for a control module, is also configured to set and adjust settings for the ventilator 12 and the ECMO system 28, as shown by the dashed lines. Thus, the monitor 34 can assist the physician in setting up the life support device by displaying set points or set point values and adjusting operating parameter values at a single point, eliminating the need for complex calculations by the physician and avoiding back and forth. This approach reduces the physician's cognitive effort when setting up the device and allows the optimal operating parameter values to be set, taking into account all relevant factors and variables.

[0093] 3B shows a corresponding system with a separate expert module 10, whereby the expert module 10 is coupled to the ventilator 12 and the ECLS system 28. In this version, the expert module 10 is optionally provided with a monitor 34, whereby the monitor 34 can be used to set or adjust settings of the ventilator 12 and the ECLS system 28, as shown schematically in dashed lines. FIG. 3C also shows a version in which the expert module 10 is integrated into the ECLS system 28, whereby the ECLS system 28 also includes the monitor 34, for example, integrated into a console. The actual values 36B of the ECLS system 28 are received directly through a common interface by implementing the expert module 10 in the ECLS system 28.

[0094] A specific example of the support of a ventilator and an ECLS system, respectively, is shown in Figure 4A, along with the measured vital parameters 16 and progress 22. In this example, four vital parameters 16 are received by the expert module: fraction of exhaled oxygen (FetO2), oxygen delivery (DO2), oxygen uptake function (VO2), and carbon dioxide output (VCO2). However, it is also possible to receive alternative vital parameters 16 or an alternative number of vital parameters 16.

[0095] The progression 22 of the vital parameters 16 is shown by way of example on a horizontal time axis in 5-minute increments over the past 20 minutes, for example, when the previously measured values are no longer relevant to the current development of the clinical situation. The measurements of the vital signs 16 are displayed next to the total value (Total, continuous line) in percentage or ml / min, separately for the specific parts: on the one hand the ventilator (Resp, dot-dash line) and on the other hand the ECLS system (ECMO, dashed line), whereby the nominal ratio 38 or ventilator part is also displayed as a value in percentage of the total value.

[0096] 4B shows a specific example of suggested 24A setpoints or setpoint values for ventilator 12 and ECLS system 28. In this example, the 24A setpoints or setpoint values for the ventilator are fraction of inspired oxygen (FiO), tidal volume (Vt), positive end-expiratory pressure (PEEP), and respiratory rate (Rf), whereas the 24B setpoints or setpoint values for the ECLS system include blood pump flow and gas volumetric flow. In addition to the suggested setpoints or setpoint values for 24A and 24B, the current actual values for 36A and 36B are also displayed, allowing the physician to easily monitor the current status and any suggested adjustments to the setpoints.

[0097] Additionally, the effect or influence of the calculated setpoint or setpoint values 24A, 24B is also shown graphically on the right, thereby illustrating the associated physiological factors 26A, 26B as polygons, here hexagons. The physiological factors 26A, 26B are arranged so that their mutual determinants are compared, with one point in the peripheral region corresponding to a negative effect on the patient's physiological condition and one point in the central region corresponding to a positive effect. The physiological factors 26A, 26B are shown so that the upper physiological factor 26A represents hyperventilation and the lower physiological factor 26B represents ventilatory failure. While such a design is arbitrary, it provides further simplification and enhanced clarity for the treating physician, as the effect or influence on the current treatment and the technical and physiological factors are simultaneously presented and can be interpreted in an understandable manner.

[0098] In the graphical representation, the effects are also shown as polygons, whereby both the effect of the current actual values 36A, 36B of the operating parameter values and the effect of the proposed set points or set point values 24A, 24B are displayed separately in different colors, as shown by reference numerals 42 and 40, respectively. Thus, it is immediately apparent how adjustment of each operating parameter value affects the patient's physiological condition, allowing the physician to adjust therapy in real time, as needed, with respect to the physiological factors 26A, 26B that are most relevant (as they are of particular importance to the patient). Color identifiers or color gradients, as shown by different hatching, may also be used as a background to the graphical representation to indicate improvement and / or tolerance ranges for each physiological factor 26A, 26B, further facilitating interpretation of the effect of the set points or set point values 24A, 24B.

[0099] Where applicable, all individual features depicted in the embodiments can be combined and / or interchanged without departing from the scope of the invention. [Explanation of symbols]

[0100] 10 Expert Modules 12 Respirator 14 patients 16 vital parameters 18 evaluation units 20 target values 22 Progress 24A,B Set point or set point value 26A,B Physiological factors 28 ECLS system or ECMO system 30 signals 32 Physiological Models 34 monitors 36A, B Actual value 38 Ratio 40 Effect of set points or set point values 42 The effect of actual values

Claims

1. An expert module (10) for a ventilator (12) for a patient (14), comprising: the expert module (10) is adapted to continuously receive at least one current vital parameter (16) of the patient (14); The expert module (10) - storing at least one vital parameter (16) for a predetermined period of time; determining a target value (20) for said at least one vital parameter (16) based on the course (22) of said at least one vital parameter (16) and / or on predetermined clinical data; and determining a setpoint or setpoint value (24A) of at least one operating parameter of the ventilator (12) based on the course (22) of the at least one vital parameter (16) and the target value (20) of the at least one vital parameter and depending on at least two physiological factors (26A, 26B) of the patient (14) representative of the patient's pulmonary function or lung function, ventilatory system and / or cardiovascular system; an evaluation unit (18) configured to The evaluation unit (18) further comprises: determining a set point or set point value (24B) for at least one operating parameter of an ECLS system (28) coupled to the patient (14) based on the history (22) of the at least one vital parameter (16) and the target value (20) of the at least one vital parameter (16) and in response to the physiological factors (26A, 26B); comparing the course (22) of the at least one vital parameter (16) with an acceptable range and / or a modeled course and outputting a signal (30) as an alarm if a deviation of the at least one vital parameter (16) beyond a predetermined threshold or limit is detected; and outputting the signal (30) representative of the set point or set point value (24A, 24B) of the operating parameter to a monitor (34) or an external device; the signal (30) indicating the proposed use of the ventilator (12) and / or the ECLS system (28); determining the set points or set point values (24A, 24B) of the operating parameters includes determining the set points or set point values (24A, 24B) from a physiological model (32) stored in the evaluation unit (18) so that a negative impact on the physiological factors (26A, 26B) is reduced and / or so that the physiological factors (26A, 26B) do not exceed a predetermined tolerance range. An expert module (10) characterized in that:

2. the expert module (10) is further adapted to receive actual values (36A, 36B) of the operating parameters from the ventilator (12) and the ECLS system (28); The evaluation unit (18) is adapted to determine the set point or set point value (24A, 24B) depending on the actual value (36A, 36B). An expert module (10) according to claim 1 .

3. The ventilator (12) is configured to support spontaneous breathing of the patient (14) or to provide artificial breathing of the patient (14). An expert module (10) according to claim 1 or claim 2.

4. The expert module (10) is coupled to a monitor (34); outputting the signal (30) comprises a graphical representation of the set point or set point value (24A, 24B), the actual value (36A, 36B), the target value (20), and / or the progression (22) of the corresponding values; An expert module (10) according to any one of claims 1 to 3.

5. the evaluation unit (18) determines the set points or set point values (24A, 24B) from a physiological model (32) stored in the evaluation unit (18); the signal (30) further comprises a graphical representation (40) of the effect (40) of the set point or set point value on the physiological factor (26A, 26B) modeled by the evaluation unit; An expert module (10) according to claim 4.

6. the effects are separate for the ventilator (12) and the ECLS system (28); and / or the signal (30) comprises a graphical representation of the effect (40) of the setpoint or setpoint value as well as a modeled effect (42) of the actual value on the physiological factor (26A, 26B); An expert module (10) according to claim 5.

7. 7. The expert module (10) according to any one of claims 1 to 6, wherein the physiological factors (26A, 26B) are not operating parameters of the ventilator (12).

8. 8. The expert module (10) according to any one of claims 1 to 7, characterized in that the physiological factors (26A, 26B) represent the functionality of the patient's lung disease or lung function.

9. 9. The expert module (10) according to any one of claims 1 to 8, characterized in that the physiological factors (26A, 26B) are indicative of hyperventilation (26A) or ventilatory insufficiency (26B).

10. 10. The expert module (10) according to any one of claims 7 to 9, characterized in that the physiological factors (26A, 26B) are selected from the group comprising mechanical lung trauma, atrophy, barotrauma, volutrauma, alkalosis, oxygen toxicity, resorptive pulmonary asystole, acidosis, hypoxia, stress and hemodynamic side effects.

11. 11. The expert module (10) according to any one of claims 7 to 10, characterized in that the evaluation unit (18) is adapted to determine the set point or set point value (24A, 24B) depending on three or more physiological factors (26A, 26B).

12. 12. The expert module (10) according to any one of claims 1 to 11, characterized in that the evaluation unit (18) is adapted to determine the setpoint values (24A, 24B) from a physiological model (32) stored in the evaluation unit (18) in such a way that the negative impact on the physiological factors (26A, 26B) is minimized and / or that the physiological factors (26A, 26B) do not exceed a predetermined tolerance range.

13. 13. The expert module (10) of any one of claims 1 to 12, characterized in that the at least one vital parameter (16) is selected from the group comprising pulse oximetry oxygen saturation, exhaled oxygen fraction, exhaled carbon dioxide fraction, oxygen uptake function, carbon dioxide release, and blood pH.

14. 14. An expert module (10) according to any one of claims 1 to 13, characterized in that the expert module (10) is adapted to receive at least two vital parameters (16).

15. the at least one operating parameter of the ventilator (12) comprises a tidal volume, a peak inspiratory pressure, a positive end-expiratory pressure, a respiratory rate, an inspired oxygen fraction, a ratio between inspiration duration and expiration duration, and / or an inspired carbon dioxide fraction; and / or the at least one operating parameter of the ECLS system (28) includes a blood pump flow rate, a system pressure, and / or a gas volumetric flow rate; An expert module (10) according to any one of claims 1 to 14.

16. 16. The expert module (10) of any one of claims 1 to 15, wherein the evaluation unit (18) is adapted to determine setpoint values (24A) for two, three, or four operating parameters of the ventilator (12) and setpoint values (24B) for two operating parameters of the ECLS system (28).

17. 17. The expert module (10) of claim 1, wherein the evaluation unit (18) is further adapted to determine the setpoint values (24A, 24B) depending on a ratio (38) of support of the ventilator (12) to the ECLS system (28) determined by the evaluation unit (18) in relation to the at least one vital parameter (16).

18. 18. The expert module (10) according to any one of the preceding claims, wherein the signal (30) further comprises a request to receive at least one further vital parameter (16).

19. 19. The expert module (10) according to any one of claims 1 to 18, characterized in that the evaluation unit (18) is adapted to compare the course (22) of the at least one vital parameter (16) with tolerances and / or modelled courses and to output a signal (30) comprising an alarm when a deviation of the at least one vital parameter (16) beyond a predetermined threshold or limit value is detected.

20. A ventilator (12) comprising an expert module (10) according to any one of claims 1 to 19.

21. 21. The ventilator (12) of claim 20, further comprising a device communicatively coupled to the expert module (10) for detecting at least one vital parameter (16) of the patient (14).

22. 22. An ECLS system (28) comprising an expert module (10) according to any one of claims 1 to 21.

23. 23. The ECLS system (28) of claim 22, comprising a device communicatively coupled to the expert module (10) for detecting at least one vital parameter (16) of the patient (14).

24. An expert module (10) according to any one of claims 1 to 23; a ventilator (12); ECLS system (28); A system comprising:

25. 20. A method for monitoring at least one vital parameter (16) of a patient (14), performed by an expert module according to any one of claims 1 to 19, comprising: continuously receiving at least one current vital parameter (16) of said patient (14); storing said at least one vital parameter (16) for a predetermined period of time; determining a target value (20) for said at least one vital parameter (16) based on a history (22) of said at least one vital parameter (16) and / or predetermined clinical data; determining a set point or set point value (24A) of at least one operating parameter of the ventilator (12) to be provided to the patient (14), the set point or set point value (24A) being determined based on a history (22) of the at least one vital parameter (16) and the target value (20) of the at least one vital parameter, and in response to at least two physiological factors (26A, 26B) of the patient (14); determining a set point or set point value (24B) for at least one operating parameter of an ECLS system (28) to be provided to the patient (14), the set point or set point value (24B) being determined based on the history (22) of the at least one vital parameter (16) and the target value (20) of the at least one vital parameter (16) and in response to the physiological factors (26A, 26B); outputting a signal (30) indicative of said set point or set point value (24A, 24B) of said operating parameter; A method comprising:

26. 26. The method of claim 25, wherein the signal (30) indicates a proposed use of the ventilator and / or the ECLS system.

27. 27. A method according to claim 25 or 26, characterized in that the step of determining the target value (20) and / or the set point or set point value (24A, 24B) is continuous or periodic.

28. 28. The method according to any one of claims 25 to 27, characterized in that the expert module (10) re-determines the target value (20) and / or the set point or set point value (24A, 24B) after manual adjustment of the operating parameter.

29. 29. The method of any one of claims 25 to 28, wherein the expert module (10) further receives actual values (36A, 36B) of the operating parameters from the ventilator (12) and the ECLS system (28) and determines the set points or set point values (24A, 24B) in response to the actual values (36A, 36B).

30. 30. The method according to any one of claims 25 to 29, characterized in that the signal (30) is output on a monitor (24) communicatively coupled to the expert module (10) as a graphic representation of the set point or set point value (24A, 24B), the actual value (36A, 36B), the target value (20) and / or the progression (22) of the corresponding values.

31. the set points or set point values (24A, 24B) are determined from a physiological model (32) stored in the expert module (10); The signal (30) further comprises a graphical representation (40) of the effect (40) of the set point or set point value on the physiological factors (26A, 26B) modeled by the expert module (10).

31. The method of claim 30.

32. The graphical representation of the effects is performed separately for the ventilator (12) and the ECLS system (28); and / or the signal (30) comprises a graphical representation of the effect (40) of the setpoint or setpoint value as well as a modeled effect (42) of the actual value on the physiological factor (26A, 26B); 32. The method of claim 31 .

33. 33. The method of any one of claims 25 to 32, wherein the physiological factors (26A, 26B) are not operating parameters of the ventilator (12).

34. 34. The method according to any one of claims 25 to 33, characterized in that the physiological factors (26A, 26B) represent the functionality of the lung disease or lung function of the patient.

35. 35. The method of any one of claims 25 to 34, wherein the physiological factors (26A, 26B) are indicative of hyperventilation (26A) or ventilatory insufficiency (26B).

36. 36. The method according to any one of claims 25 to 35, characterized in that upon determining a (maximally) positive effect on at least one physiological factor (26A), the effect on at least one other physiological factor (26B) is calculated or simulated or modeled, respectively.

37. 37. The method according to any one of claims 25 to 36, wherein the set points or set point values (24A, 24B) are determined based on a physiological model (32) stored in the expert module (10) so as to have minimal negative effects on the physiological factors (26A, 26B) and / or so that the physiological factors (26A, 26B) do not exceed predetermined tolerances.

38. 38. The method of any one of claims 25 to 37, wherein the set point or set point value (24A, 24B) is determined in response to a ratio (38) determined by the expert module of the intensity of support provided by the ventilator (12) to the intensity of support provided by the ECLS system (28) associated with the at least one vital parameter (16).

39. 39. The method of any one of claims 25 to 38, wherein the signal (30) further comprises a request to receive at least one further vital parameter (16).

40. the course (22) of the at least one vital parameter (16) is compared with tolerances and / or modeled courses in the expert module (10); an alarm is output upon detection of a deviation of said at least one vital parameter (16) beyond a predetermined threshold or limit; 40. The method of any one of claims 25 to 39.

41. 41. The method of any one of claims 25 to 40, wherein the expert module (10) issues an alarm when the manually set value of the operating parameter exceeds a predetermined threshold or limit of the modeled effect on the operating parameter, the at least one vital parameter (16), and / or the physiological factor (26A, 26B).

42. 42. The method according to any one of claims 25 to 41, wherein the expert module (10) is an expert module (10) according to any one of claims 1 to 19.

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