PROCESS AND APPARATUS FOR MONITORING A VENTILATOR
20230191056 · 2023-06-22
Inventors
Cpc classification
A61N1/36014
HUMAN NECESSITIES
G16H20/40
PHYSICS
A61B5/08
HUMAN NECESSITIES
A61M2016/0036
HUMAN NECESSITIES
A61M2230/04
HUMAN NECESSITIES
A61M16/0069
HUMAN NECESSITIES
A61M2230/005
HUMAN NECESSITIES
A61M16/024
HUMAN NECESSITIES
A61M2230/04
HUMAN NECESSITIES
A61M2230/005
HUMAN NECESSITIES
International classification
Abstract
A process and apparatus monitor a ventilator (100). The ventilator (100) performs supportive artificial ventilation including a sequence of ventilation strokes, with the objective that each inspiration effort of the patient (Pt) triggers a ventilation stroke and the start and the end of the ventilation stroke coincide with the start and the end of the inspiration effort, respectively. A monitoring unit (11) detects deviations between the patient's own inspiratory efforts and the artificial ventilation and determines a respective measure for the respective frequency and/or duration for different possible asynchrony types.
Claims
1. A monitoring process for monitoring a ventilator, the process comprising the steps of: providing a signal processing monitoring unit for monitoring the ventilator, wherein the ventilator is configured to perform supportive artificial ventilation of a patient, the supportive artificial ventilation including receiving measured values from a sensor arrangement comprising at least one respiratory sensor configured and arranged to measure a respective indicator which correlates with a patient's own inspiratory efforts, the supportive artificial ventilation further including evaluating measured values of the sensor arrangement to generate at least one respiratory signal which is an indication of the patient's own inspiratory efforts, and depending on the respiratory signal, to perform a sequence of ventilation strokes with an objective that the respective start and the respective end of each inspiration effort of the patient trigger the start and the end, resp., of exactly one ventilation stroke, wherein at least two possible asynchrony types are predefined, which are different from each other, wherein a predefined possible asynchrony type has actually occurred if a ventilation stroke begins or ends earlier or later than the inspiratory effort triggering this ventilation stroke, or if a ventilation stroke is triggered without an inspiratory effort or if an inspiratory effort does not trigger a ventilation stroke; the process of monitoring the ventilator with the monitoring unit is performed while the ventilator is performing supportive artificial ventilation of the patient; the monitoring process comprising the steps of detecting with the monitoring unit the respective start and end of each inspiratory effort of the patient, wherein the respiratory signal is evaluated for this detection; determining with the monitoring unit a respective start and end of each ventilation stroke; detecting with the monitoring unit any actual occurrence of a predefined possible asynchrony type at least if its duration is above a predefined asynchrony duration threshold; and determining with the monitoring unit a respective measure for a frequency and/or for a respective duration of the actual occurrence of each predefined possible asynchrony type occurring during the sequence of ventilation strokes.
2. A monitoring process of claim 1, further comprising determining with the monitoring unit which one of four possible situations is present at each sampling time point of a predefined series of sampling time points, evaluating the respiratory signal when determining which situation is present at a sampling time point, the four possible situations comprising: the patient performs an inspiratory effort, and the ventilator performs a ventilation stroke; neither the patient performs an inspiratory effort nor does the ventilator perform a ventilation stroke; the patient performs an inspiratory effort, and the ventilator does not perform a ventilation stroke; and the ventilator performs a ventilation stroke, and the patient does not perform an inspiratory effort, wherein the step of determining the measures for frequency and/or duration of the predefined possible asynchrony types comprises the step of determining a series of situations, wherein the series of situations comprises one situation per sampling time point of the series of sampling times, wherein in the series of situations each situation sequence of is determined, wherein a determined situation sequence comprises at least two different immediately successive situations of the series of situations which successive situations differ from each other, and wherein for each predefined possible asynchrony type, the measure for a frequency of asynchrony and/or the measure for a duration of asynchrony is determined by using the determined situation sequences in which the predefined possible asynchrony type is actually present.
3. A monitoring process of claim 2, wherein the measure for the respective frequency and/or duration of each predetermined possible asynchrony type is determined by the monitoring unit depending on the respective frequency and/or duration of those situation sequences in which this asynchrony type is present.
4. A monitoring process according to claim 1, wherein: the ventilator is adapted to automatically detect when the patient starts and stops an inspiratory effort; the ventilator is configured to apply a decision rule to the expiratory signal when detecting the inspiratory effort start and stop, said decision rule depends on at least one parameter; the monitoring process further comprises the steps of: calculating with the monitoring unit at least once a target setpoint for the parameter of the decision rule, the target setpoint is calculated depending on at least one determined measure for the frequency and/or duration of a possible asynchrony type; and transmitting a message to the ventilator or outputting a message in a form perceptible by a human, wherein the message comprises information about the calculated target setpoint and/or about a change in the currently used setpoint of the parameter wherein the change depends on the target setpoint, and changing the applied decision rule of the ventilator in response to the received message or to a user input.
5. A monitoring process according to claim 1, further comprising: generating with the monitoring unit at least one presentation that shows the respective determined measures for the frequency and/or duration of at least two of the predetermined possible asynchrony types occurred during the sequence of ventilation strokes; and triggering with the monitoring unit the step that the generated presentation is output in a form that can be perceived by a human.
6. A monitoring process according to claim 5, wherein: for each possible asynchrony type, which is shown in the presentation, a measure for the frequency and a measure for the duration of the possible asynchrony type is determined; and for each of the presented possible asynchrony types both measures are shown in the presentation.
7. A monitoring process according to claim 6, wherein: the presentation is generated using two axes, which two axes are perpendicular or oblique to each other; a measure for the frequency of the respective possible asynchrony type is plotted on one axis and a measure for the duration of the same possible asynchrony type is plotted on the other axis; and each of the asynchrony types shown in the presentation is shown by means of a rectangular or trapezoidal surface area, with two dimensions of this area depending upon the two measures.
8. A monitoring process according to claim 1, wherein the monitoring unit detects any occurrence of the following eight predetermined possible asynchrony types at least when occurring above a predetermined duration threshold: a ventilation stroke triggers an inspiratory effort (reverse triggering); a ventilation stroke is triggered too late (late triggering); a ventilation stroke is ended too late (late cycling off); a ventilation stroke is ended too early (premature cycling off); a ventilation stroke is triggered without an inspiration effort (auto triggering); an inspiration effort does not trigger a ventilation stroke (missed effort); a first inspiratory effort is terminated during a ventilation stroke, and a second inspiratory effort is started during the same ventilation stroke (missed expiration); and a first ventilation stroke is completed during an inspiratory effort, and a second ventilation stroke is started during the same inspiratory effort (double triggering).
9. A monitoring process according to claim 8, wherein the monitoring unit: generates a first presentation which refers to the first four of the eight possible asynchrony types; and/or generates a second presentation, which refers to the last four of the eight possible asynchrony types wherein the monitoring unit causes the first and/or the second presentation to be output in a form perceptible by a human, wherein depending on a user input, either the first presentation or the second presentation or both presentations are output.
10. A computer program on a non-transitory computer-readable medium, the computer program being executable on a signal processing monitoring unit with a data communication with a ventilator, the ventilator configured to perform supportive artificial ventilation of a patient, the ventilator configured during the supportive artificial ventilation to receive measured values from a sensor arrangement comprising at least one respiratory sensor configured and arranged to measure a respective indicator which correlates with a patient's own inspiratory efforts; to generate at least one respiratory signal, which is an indication of the patient's own inspiratory effort, generating the signal by evaluating measured values of the sensor arrangement; depending on the respiratory signal, to perform a sequence of ventilation strokes with an objective that the respective start and the respective end of each inspiration effort of the patient trigger the start and the end, resp., of exactly one ventilation stroke, wherein at least two possible asynchrony types are predefined, which are different from each other, wherein a predefined possible asynchrony type has actually occurred if a ventilation stroke begins or ends earlier or later than the inspiratory effort triggering this ventilation stroke, or if a ventilation stroke is triggered without an inspiratory effort or if an inspiratory effort does not trigger a ventilation stroke; with execution of the computer program on the signal processing monitoring unit, the computer program causes the signal processing monitoring unit to: monitor the ventilator with the monitoring unit while the ventilator is performing supportive artificial ventilation of the patient; detect the respective start and end of each inspiratory effort of the patient, wherein the respiratory signal is evaluated for the detection; determine a respective start and end of each ventilation stroke; detect any actual occurrence of a predefined possible asynchrony type at least if its duration is above a predefined asynchrony duration threshold; and determine a measure for a respective frequency and/or for a respective duration of the actual occurrence of each predefined possible asynchrony type occurring during the sequence of ventilation strokes.
11. A ventilating process for supportive artificial ventilation of a patient by a ventilator, the ventilating process comprising the steps of: during supportive artificial ventilation, receiving with the ventilator measured values from a sensor arrangement comprising at least one respiratory sensor configured and arranged to measure a respective indicator which correlates with a patient's own inspiratory efforts; generating with the ventilator at least one respiratory signal, which respiratory signal is a measure for the patient's own inspiratory effort, the respiratory signal is generated by evaluating sensor measurement values; with the ventilator, performing a sequence of ventilation strokes based on the respiratory signal with the objective that the respective start and the respective end of each inspiration effort of the patient trigger the start and the end, resp., of exactly one ventilation stroke, wherein at least two possible asynchrony types are predefined, which are different from each other, wherein a predefined possible asynchrony type has actually occurred if a ventilation stroke begins or ends earlier or later than the inspiratory effort triggering this ventilation stroke, or a ventilation stroke is triggered without an inspiratory effort or an inspiratory effort does not trigger a ventilation stroke; detecting with a signal processing monitoring unit the respective start and end of each inspiratory effort of the patient, wherein the respiratory signal is evaluated for the detection; determining with the signal processing monitoring unit the respective start and end of each ventilation stroke; detecting with the signal processing monitoring unit every actual occurrence of a predefined possible asynchrony type at least if its duration is above a predefined asynchrony duration threshold; and determining with the signal processing monitoring unit a respective measure for a frequency and/or a respective duration of the actual occurrence of each predefined possible asynchrony type occurring during the sequence of ventilation strokes is determined.
12. A signal processing monitoring unit for monitoring a ventilator, wherein the ventilator is configured to perform supportive artificial ventilation of a patient, the supportive artificial ventilation including receiving measured values from a sensor arrangement comprising at least one respiratory sensor configured and arranged to measure a respective indicator which correlates with a patient's own inspiratory efforts and generating at least one respiratory signal, which is an indication of the patient's own inspiratory effort by evaluating measured values, the ventilator is configured to perform, depending on the respiratory signal, a sequence of ventilation strokes with the objective that the respective start and the respective end of each inspiration effort of the patient trigger the start and the end, resp., of exactly one ventilation stroke, wherein at least two possible asynchrony types are predefined, which are different from each other, wherein a predefined possible asynchrony type has actually occurred if a ventilation stroke begins or ends earlier or later than the inspiratory effort triggering the ventilation stroke, or a ventilation stroke is triggered without an inspiratory effort or an inspiratory effort does not trigger a ventilation stroke, the monitoring unit is configured to: detect the respective start and the respective end of each inspiratory effort of the patient by evaluating the expiratory signal; determine the respective start and end of each ventilation stroke; detect any actual occurrence of a predefined possible asynchrony type at least if its duration is above a predefined asynchrony duration asynchrony; and determine a respective measure for a respective frequency and/or a respective duration of the actual occurrence of each predefined possible asynchrony type occurring during a sequence of ventilation strokes.
13. A monitoring unit according to claim 12, wherein the monitoring unit is configured to: determine, at each sampling time point of a predefined series of sampling time points, which one of the following four possible situations exists at that sampling time point: the patient performs an inspiratory effort, and the ventilator performs a ventilation stroke; neither the patient performs an inspiratory effort nor does the ventilator perform a ventilation stroke; the patient performs an inspiratory effort, but the ventilator does not perform a ventilation stroke; the ventilator performs a ventilation stroke, but the patient does not perform an inspiratory effort, wherein the monitoring unit is configured to use the respiratory signal for determining which situation is present at a sampling time point, wherein the monitoring unit is configured, in determining the measures of frequency and/or duration for the predetermined possible asynchrony types, to determine a series of situations, wherein the series of situations comprises one situation per sampling time point of the series, wherein the monitoring unit is configured to determine in the series of situations each situation sequence, wherein a determined situation sequence comprises at least two different immediately successive situations which differ from each other, and wherein the monitoring unit is configured, for each predefined possible asynchrony type, to determine the measure for the frequency and/or duration of the predefined possible asynchrony type using those determined situation sequences of in which that asynchrony type is actually present.
14. A monitoring unit according to claim 12, wherein: the ventilator is configured to apply a decision rule to the respiratory signal, to decide when the patient starts and stops an inspiratory effort, said decision rule depending on at least one parameter; the monitoring unit is configured to: calculate at least once a target setpoint for the parameter of the decision rule; and cause a message to be transmitted to the ventilator or output in a form perceptible by a human; wherein the message comprises information about the calculated target setpoint and/or about a change in the currently used setpoint of the parameter; the ventilator is configured to automatically change the applied decision rule in response to the received message or on a user input.
15. A ventilation arrangement comprising: a sensor arrangement comprising one or more respiratory sensors configured and arranged to measure a respective indicator which correlates with a patient's own inspiratory efforts to provide measured values; a ventilator configured to perform supportive artificial ventilation of the patient, and while doing so receive measured values from the sensor arrangement to generate at least one respiratory signal, which is an indication of the patient's own inspiratory effort, the ventilator configured, depending on the respiratory signal, to perform a sequence of ventilation strokes with the objective that the respective start and the respective end of each inspiration effort of the patient trigger the start and the end, resp., of exactly one ventilation stroke, wherein at least two possible asynchrony types are predefined, which are different from each other, wherein a predefined possible asynchrony type has actually occurred if a ventilation stroke begins or ends earlier or later than the inspiratory effort triggering this ventilation stroke, or a ventilation stroke is triggered without an inspiratory effort or when an inspiratory effort does not trigger a ventilation stroke; and a signal processing monitoring unit configured to: detect the respective start and the respective end of each inspiratory effort of the patient by evaluating the respiratory signal; determine the respective start and end of each ventilation stroke; detect any occurrence of a predetermined possible asynchrony type at least if its duration is above a predetermined asynchrony duration asynchrony; and determine a measure for the respective frequency and/or the respective duration of the actual occurrence of each predefined possible asynchrony type occurring during a sequence of ventilation strokes.
16. A ventilation arrangement according to claim 15, wherein: the monitoring unit is a component of the ventilator; and the ventilator further comprises a further signal processing unit configured: to receive measured values from the sensor arrangement and to generate the respiratory signal by evaluating sensor measured values; and to trigger the sequence of ventilation strokes.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0081] In the drawings:
[0082]
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DESCRIPTION OF PREFERRED EMBODIMENTS
[0089] Referring to the drawings, in an embodiment, the invention is used to artificially ventilate a patient and thereby support the patient's own respiratory activity. The patient's own respiratory activity can be brought about by the patient's spontaneous breathing and/or by external stimulation of the patient's respiratory muscles.
[0090] A fluid connection is established between the patient's airway and a ventilator. Through this fluid connection, the ventilator supplies the patient with breathing air or another gas mixture containing oxygen. This gas mixture may comprise at least one anesthetic. In particular, when the patient is anesthetized, the fluid connection may be part of a ventilation circuit between the patient and the ventilator.
[0091]
[0092] A ventilator 100 with a display and control unit 12 and a signal processing unit 10 artificially ventilates the patient Pt. A fluid connection is established between the ventilator 100 and the patient-side coupling unit 4, 6. The ventilation tubing between the ventilator 100 and the patient Pt is not shown.
[0093] Various respiratory sensors measure various pneumatic or electrical or mechanical vital parameters of the patient Pt and/or parameters of the gas flow between the ventilator 100 and the lungs Lu of the patient Pt or of the gas delivered to the patient-side coupling unit 4, 6. To carry out the invention, not all of these respiratory sensors necessarily need to be present. The following respiratory sensors are shown as examples in
[0099] The signal processing unit 10 is capable of automatically determining when air or another gas mixture flows into the respiratory system of the patient Pt and when a gas mixture flows out of the respiratory system again. Thus it is ideally capable of detecting each inspiration phase and each expiration phase of the patient Pt's own respiratory activity. For this purpose, the signal processing unit 10 uses measured values from at least one of the sensors 2, 3, 7 and 15 and optionally from the measuring electrodes 5.1.1 to 5.2.2.
[0100] The ventilator 100 performs a sequence of ventilation strokes. The signal processing unit 10 repeatedly automatically triggers the two steps of starting a ventilation stroke and ending it during the supportive artificial ventilation. The signal processing unit 10 controls a corresponding actuator (not shown) of the ventilator 100, for example a pump or at least one valve interacting with a blower. During each ventilation stroke, the ventilator 100 feeds breathing air or other gas mixture into the fluid connection, and this gas mixture flows to the patient Pt.
[0101] In the embodiment, the patient Pt's own respiratory muscles draw in a gas mixture, i.e. the patient Pt inhales a gas mixture from the fluid connection. The inhalation may be caused by the spontaneous breathing of the patient Pt. Optionally, the patient's respiratory muscles are externally stimulated. The ventilator 100 assists the patient Pt's own breathing activity by the ventilator 100 delivering a gas mixture to the lungs Lu, said gas mixture comprising oxygen.
[0102] In the following, a distinction is made between the terms “inhalation process” and “inspiratory effort” of patient Pt. The patient's own respiratory musculature Pt, which is stimulated in the patient Pt's body itself and/or externally stimulated, attempts to suck in a gas. This attempt is called an inspiratory effort. If this attempt succeeds, i.e. a relevant amount of the aspirated gas actually flows into the lungs Lu, then the patient Pt has actually taken a breath and therefore also performed an inhalation process. However, it is also possible that an inspiratory effort does not cause an inhalation event that results in a measurable/relevant volume flow into the airway of the patient Pt. In particular, this situation may occur when the lungs Lu of the patient Pt are not very elastic and therefore a relatively large amount of used air remains in the lungs Lu after an exhalation event, leaving little room for new gas. Furthermore, in some situations, the ventilator 100 performs an occlusion. During an occlusion, the patient Pt is briefly prevented from actually breathing in. During such an occlusion, in many cases a lung mechanical parameter of the patient Pt can be better measured than in a situation where gas flows into the lungs Lu of the patient Pt.
[0103] Ideally, any inspiratory effort performed by the patient Pt with the patient's own respiratory muscles immediately triggers a ventilation stroke of the ventilator 100, in one embodiment except during an occlusion. Ideally, this ventilation stroke is immediately terminated when the patient Pt ceases the inspiratory effort. Thus, each inspiratory effort of the patient Pt ideally triggers exactly one ventilation stroke of the ventilator 100, and each ventilation stroke is triggered by exactly one inspiratory effort. The ventilation strokes of the ventilator 100 are thus ideally fully synchronized with the patient Pt's own respiratory activity.
[0104] The patient's own respiratory muscles Pt perform breaths in which air or another gas mixture first flows into the lungs (inspiration) and then flows out of the lungs again (expiration). In the following, the term “inspiration” is also used for an inspiratory effort that does not result in a measurable breath and thus does not result in a measurable inhalation process.
[0105] The respiratory sensors described above are each capable of providing measured values. From measured values from at least one respiratory sensor, the signal processing unit 10 generates a signal that correlates with the patient Pt's own respiratory activity. This signal is referred to as a “respiratory signal” and is denoted by Sig.sub.res. Typically, readings from different respiratory sensors will result in different respiratory signals. Typically, the actual respiratory activity of patient Pt differs at least some of the time from the respiratory signal or each respiratory signal Sig.sub.res obtained, such that the respiratory signal or each respiratory signal Sig.sub.res is only an approximation of patient Pt's own actual respiratory activity.
[0106] In one embodiment, the signal processing unit 10 detects, by evaluating at least one respiratory signal Sig.sub.res, that the patient Pt's own respiratory muscles have started an inhalation process or at least an inspiratory effort (start of an inspiration phase). The readings leading to this respiratory signal Sig.sub.res come from the or at least one pneumatic respiratory sensor, for example the pneumatic sensor 2 in front of the patient Pt's mouth, the probe 3 in the patient Pt's esophagus Sp or the gastral probe 7 in the patient Pt's stomach. The readings from these pneumatic respiratory sensors each result in a pneumatically obtained respiratory signal Sig.sub.res.
[0107] In a preferred embodiment, at least one pneumatic respiratory signal Sig.sub.res is used which correlates with the patient's inspiratory efforts Pt and not only with the breaths actually taken. The pneumatic respiratory sensors 15, 3 and 7 are capable of providing measured values from which such a respiratory signal Sig.sub.res is generated. The respiratory signal Sig.sub.res, which is generated from the measured values of the pneumatic respiration sensor 2, on the other hand, correlates with the breaths actually taken by the patient Pt.
[0108] In another embodiment, the fact that the patient Pt's own respiratory muscles are stimulated to move by a sequence of electrical pulses generated in the patient Pt's body and/or optionally by a stimulating device is exploited. These electrical impulses can be measured and result in an electrical signal. This electrical signal for the respiratory muscles correlating with the internal and/or external stimulation is referred to as an “electrical respiratory signal” and can be measured approximately. The cardiac activity of the patient Pt is triggered by another sequence of electrical signals generated in the body of the patient Pt. From this sequence, a signal for cardiac activity can be generated, which is referred to as a “cardiogenic signal”.
[0109] For the measured values of the measuring electrodes 5.1.1 to 5.2.2 as well as the measured values of the reference electrode not shown, a signal preprocessing is carried out in one embodiment, which preferably comprises a summation and a smoothing of the measured electrical measured values and provides a so-called envelope. This envelope is or provides a sum signal Sig.sub.Sum, which results from a superposition of the electrical respiratory signal with the cardiogenic signal and may be influenced by interfering signals. Interfering signals can come from the patient Pt's body and from the environment. The influence of the cardiogenic signal on the sum signal Sig.sub.Sum is at least approximately compensated by calculation. For example, in the sum signal Sig.sub.Sum those sections are detected which originate from one heartbeat each, for example one so-called QRS section each. Or a standardized course of the cardiogenic signal in the course of a single heartbeat is subtracted from the sum signal, a so-called ECG template. The computational compensation provides an approximation for the electrical respiratory signal Sig.sub.res. The estimate for the electrical respiratory signal Sig.sub.res obtained in this way also indicates when the patient Pt begins an inspiratory effort and when the patient Pt ends it.
[0110] It is possible that a first electrical respiratory signal Sig.sub.res is obtained from measured values of the pair 5.1.1, 5.1.2 near the heart and a second electrical respiratory signal is obtained from measured values of the pair 5.2.1, 5.2.2 near the diaphragm. As a rule, these two electrical signals differ from each other.
[0111]
[0112] In a further embodiment not shown, readings from a mechano-myographic sensor provide a mechanical respiratory signal that correlates with the activity of the patient's own respiratory muscles Pt.
[0113] The signal processing unit 10 detects in at least one respiratory signal Sig.sub.res the respective start and the respective end of each inspiratory effort. The embodiments just described for generating respiratory signals in different ways can be combined with each other. In one embodiment, at least two different respiratory signals are present. These respiratory signals ideally match, but in practice generally differ from each other and from the actual inspiratory efforts. In one embodiment, the signal processing unit 10 generates an averaged respiratory signal Sig.sub.res from a plurality of respiratory signals and uses this averaged respiratory signal Sig.sub.res, to detect the patient Pt's inspiratory efforts. On the other hand, in another embodiment, the signal processing unit 10 uses a plurality of respiratory signals to detect the inspiratory efforts of the patient Pt.
[0114] Ideally, each inspiratory effort or at least each inhalation event of the patient Pt is visible in the or each respiratory signal Sig.sub.res, furthermore each exhalation event. Ideally, the signal processing unit 10 detects each inspiratory effort in each respiratory signal Sig.sub.res and always detects those times at which the inspiratory effort starts or ends. Ideally, the respiratory strokes of the ventilator 100 are synchronized with the inspiratory efforts of the patient Pt.
[0115] In practice, an inspiratory effort may not be detected at all in the or at least one respiratory signal Sig.sub.res. Furthermore, it is possible that the signal processing unit 10 detects the same inspiratory effort of the patient Pt in multiple respiratory signals Sig.sub.res, but with different times for the start and/or for the end of the inhalation. The different estimates may be combined at the wrong time or even misclassified as two different inspiratory efforts. It is also possible that the signal processing unit 10 in the respiratory signal or a respiratory signal Sig.sub.res supposedly detects an inspiratory effort, although the patient Pt has not performed an inspiratory effort at that time. Indeed, the respiratory signal or each respiratory signal Sig.sub.res inevitably deviates from the patient Pt's own actual respiratory effort. Some reasons for this are: a distance occurs between the diaphragm Zw and other regions of the patient Pt's body that cause the inspiratory efforts and the measurement point at which the measurement values for a respiratory signal Sig.sub.res are measured, whereby interfering signals may become effective. In addition, measurement inaccuracies and measurement errors of the sensors used usually occur, and further signals generated in the patient Pt's body or even outside may affect the respiratory signal Sig.sub.res obtained. It is also possible that the signal processing unit 10 does not detect an inspiratory effort of the patient Pt at all.
[0116] Preferably, the signal processing unit 10 detects an inspiratory effort of the patient Pt when this inspiratory effort becomes visible in the respiratory signal or at least one respiratory signal Sig.sub.res, even when this inspiratory effort does not become visible in another respiratory signal Sig.sub.res. If the same inspiratory effort is visible in several respiratory signals, the signal processing unit 10 preferably detects in at least two of these respiratory signals the respective time for the start and the end of the inhalation. If multiple respiratory signals are present, in one embodiment the signal processing unit 10 averages over the detected times for the start of the inspiratory effort and averages over the detected times for the end of the inspiratory effort, thereby determining an averaged start time and an averaged end time for each inspiratory effort. In this averaging, weight factors are taken into account in one embodiment, where a weight factor is greater the more reliable a particular respiratory sensor and/or the more reliable the derivation of the respiratory signal from that sensor. It is also possible that the time points in the respiratory signal that currently has the highest reliability are used.
[0117] As a rule, a period of time elapses between the time at which the patient Pt begins or ends an inspiratory effort and the time at which this event is detected in a pneumatic respiratory signal Sig.sub.res, in particular if the pneumatic respiratory sensor used is located outside the body of the patient Pt. One reason is that the inspiratory effort must have resulted in a sufficiently large volume flow at the respective measuring point of a pneumatic respiratory sensor before the inspiratory effort is detected in the respiratory signal Sig.sub.res from this respiratory sensor. Moreover, time also elapses between the time when the patient Pt's body or even a stimulating device generates electrical impulses which activate the patient's own respiratory muscles and which are measured, and the time when the patient's own respiratory muscles actually begin an inspiratory effort. This time span may depend on the so-called neuromuscular efficiency of the patient's own respiratory musculature, i.e. how quickly and how well the patient's own respiratory musculature Pt responds to stimulating electrical impulses. These two time spans can be estimated in many cases, but any estimate may be subject to uncertainty.
[0118] The patient's actual own respiratory activity and therefore the respiratory signal or each respiratory signal Sig.sub.res generally oscillate, and generally the amplitude and frequency of this oscillation varies over time. The signal processing unit 10 of the ventilator 100 automatically applies a decision rule to the or each respiratory signal Sig.sub.res obtained to detect in the respiratory signal Sig.sub.res the start and end of an inspiratory effort of the patient Pt, and to start and end a ventilation stroke depending on the detected start and end of the detected inspiratory effort. This decision rule applies parameters in many cases, for example the following operating parameters: [0119] If a measure for the volume flow of respiratory air to the lungs Lu of the patient Pt is greater than a predetermined barrier x, optionally greater than the barrier x within a predetermined time period T, it is decided that the patient Pt has started an inspiratory effort, and a new ventilation stroke is started. [0120] If the measure for this volume flow becomes less than a percentage y of the last measured maximum volume flow, i.e. the maximum volume flow at this inspiratory effort, it is decided that the patient Pt has completed the inspiratory effort, and the current ventilation stroke is terminated.
[0121] Setpoints for these operating parameters x, y are determined on the basis of the following conflicting requirements: [0122] Every inspiratory effort should be detected. [0123] The start and end of each inspiratory effort that the patient Pt actually performs should be detected as accurately as possible. [0124] During supportive ventilation, a ventilation stroke should only be performed if patient Pt is also making an effort to breathe in. It should be avoided that a ventilation stroke is erroneously executed due to a supposed inspiration effort, although the patient Pt is not inhaling. In particular, it is generally intended to avoid the ventilator 100 performing a ventilation stroke while the patient Pt is exhaling.
[0125]
[0126] In the example shown, the ventilation strokes are started and ended depending on a pneumatic respiratory signal Sig.sub.res, i.e. depending on readings from at least one pneumatic sensor 15, 3, 7. In the example shown, each ventilation stroke starts and ends later than the inspiratory effort that triggers that ventilation stroke. Various possible reasons for the supportive artificial ventilation “lagging behind” the patient's own respiratory activity have already been mentioned above.
[0127] It is also possible that a ventilation stroke begins earlier than the inspiratory effort that triggers that ventilation stroke. In particular, this situation may occur if the ventilation stroke is triggered by an estimate for an electrical respiratory signal Sig.sub.res, where this electrical signal Sig.sub.res is generated depending on electrical pulses generated in the patient Pt's body and not by the start of an executed inspiratory effort. One possible cause of a ventilation stroke starting too early is the following: a threshold to detect an electrical respiratory signal Sig.sub.res for a patient Pt inspiratory effort is set too low, i.e., the sensor is too sensitive. Possible reasons for supportive artificial ventilation to precede the patient's own respiratory effort have also been mentioned above.
[0128] At each sampling time, the following four situations may occur, which in a preferred embodiment are encoded with four different values. The following table 1 shows these four situations and exemplary their respective coding.
TABLE-US-00001 TABLE 1 Ventilation stroke performed Inspiratory effort performed (air flows from ventilator (own respiratory muscles Coding 100 to patient Pt)? trying to draw in breath)? 0 No No 1 Yes No 2 No Yes 3 Yes Yes
Of course, other codings than the digits 0, 1, 2, 3 are also possible.
[0129] In the following, the designations “Situation 0” to “Situation 3” are used as abbreviations. These codings are entered as an example under the x-axis in
[0130] In the following, a sequence of three situations is referred to as a “sequence”, provided that two situations immediately following each other are different from each other.
[0131] If the ventilator 100 is ideally synchronized with the patient Pt's own respiratory activity, only situations 0 and 3 occur. An ideally synchronized ventilation stroke leads to the situation sequence [0, 3, 0]. In practice, situations 1 and 2 usually occur as well. These situations mean asynchrony.
[0132] As a rule, it is completely harmless for the patient Pt if the start and end of a ventilation stroke does not deviate from the start and end of the inspiratory effort that triggers this ventilation stroke by more than a predefined duration limit. This duration limit may be fixed for all patients Pt and all situations and may be, for example, 100 msec. The duration limit may also depend on measured vital parameters of the patient Pt and/or on the way in which the ventilation strokes differ from the inspiratory efforts. Therefore, in the following, a situation 1 or 2 is only registered if this situation 1 or 2 lasts longer than the predetermined duration limit. This can be ensured, for example, with a sufficiently large sampling frequency or with signal preprocessing.
[0133] Situations 1 and 2 are referred to as “asynchrony situations”.
[0134] A sequence of sampling time points is predefined. For each sampling time point it is automatically determined which of the four possible situations 0, 1, 2, 3 is present at this sampling time point. This procedure provides a sequence of situations. As explained earlier, a section of the situations sequence consisting of three situations in immediate succession is called a “sequence”, provided that two situations in immediate succession are different from each other. Examples of situation sequences are [0,1,0], [2,3,0] and [1,0, 3]. With n=4 different possible situations there are
n*(n-1)*(n-1)=36
various possible situation sequences.
[0135] An “asynchrony sequence” is defined as a situation sequence in which the situation in the middle is an asynchrony situation, i.e. equal to 1 or equal to 2. The invention makes it possible to selectively detect the asynchrony sequences during supportive artificial ventilation of the patient Pt. With n=4 different possible situations and m=2 asynchrony situations, there are
(n-1)*m*(n-1)=18
various possible asynchrony sequences.
[0136] The following Table 2 shows by way of example which of these 18 possible asynchrony sequences have which technical meanings.
TABLE-US-00002 TABLE 2 Sequence technical importance [0, 1, 0] Ventilation stroke performed without a temporally overlapping inspiratory effort [0, 1, 2] First neither ventilation stroke nor inspiration effort, then only ventilation stroke performed, then only inspiration effort performed [0, 1, 3] Ventilation stroke started before inspiratory effort [0, 2, 0] Inspiratory effort performed without a temporally overlapping ventilation stroke [0, 2, 1] First only inspiratory effort, immediately afterwards only ventilation stroke performed [0, 2, 3] Inspiratory effort started before ventilation stroke [1, 2, 0] Ventilation stroke terminated before inspiration effort [1, 2, 1] Inspiratory effort started and ended during a ventilation stroke [1, 2, 3] Ventilation stroke started before inspiratory effort [2, 1, 0] Inspiratory effort terminated before ventilation stroke [2, 1, 2] Ventilation stroke started and ended during inspiration effort [2, 1, 3] Inspiratory effort started before ventilation stroke [3, 1, 0] Inspiratory effort terminated before ventilation stroke [3, 1, 2] First inspiration effort finished before ventilation stroke, then second inspiration effort started without ventilation stroke [3, 1, 3] First inspiratory effort completed during one breath and second inspiratory effort started during the same breath. [3, 2, 0] Ventilation stroke terminated before inspiration effort [3, 2, 1] First ventilation stroke completed before inspiration effort, second ventilation stroke started without inspiration effort. [3, 2, 3] First ventilation stroke completed during an inspiratory effort and second ventilation stroke started during the same inspiratory effort.
[0137] Table 3 below shows the clinical meanings for eight relatively common asynchrony type sequences. These eight asynchrony type sequences function as eight possible asynchrony types within the meaning of the claims.
TABLE-US-00003 TABLE 3 clinical significance Sequence clinical significance (details) (terms) [0, 1, 0] Ventilation stroke triggered by itself Auto Triggering [0, 1, 3] Ventilation stroke triggers inspiratory Reverse Triggering effort [0, 2, 0] Inspiratory effort missed Missed Effort [0, 2, 3] Ventilation stroke triggered too late Late Triggering [3, 1, 0] Ventilation stroke ended too late Late Cycling Off [3, 1, 3] End of an inspiratory effort missed Missed Expiration (exhalation missed) [3, 2, 0] Ventilation stroke ended too early Premature Cycling Off [3, 2, 3] new ventilation stroke triggered Double Triggering during inspiration effort
[0138] Two classes of asynchrony sequences can be distinguished, namely time asynchronies and event asynchronies (desynchronies). In a time asynchrony, the ventilation stroke starts later or earlier than the inspiratory effort that triggers this ventilation stroke. If only time asynchronies occur during supportive artificial ventilation, each inspiratory effort of the patient Pt triggers exactly one ventilation stroke of the ventilator 100. In an event asynchrony, an inspiration effort does not trigger a ventilation stroke at all, or a ventilation stroke is triggered without an inspiration effort. Or, an inspiratory effort by the patient Pt is supported by a ventilation stroke, but the patient interrupts the inspiratory effort, or the ventilator 100 interrupts the supporting ventilation stroke. The four relatively frequent asynchrony sequences [0,1,3], [0,2,3], [3,2,0], and [3,1,0] are time asynchronies, and the remaining four relatively frequent asynchrony sequences [0,2,0], [3,1,3], [0,1,0], and [3,2,3] are event asynchronies.
[0139] A signal processing monitoring unit 11, which monitors the supportive artificial ventilation by the ventilator 100 and which comprises a processor and a data memory, receives the generated respiratory signal Sig.sub.res, optionally each individual respiratory signal Sig.sub.res from different respiratory sensors, and detects in the or each respiratory signal Sig.sub.res obtained the inspiratory efforts of the patient Pt and for each inspiratory effort its respective start and its end. Because this monitoring unit 11 monitors the ventilator 100 but does not itself initiate any ventilation stroke, the monitoring unit 11 can evaluate a longer section of the or each respiratory signal Sig.sub.res. For this evaluation, the monitoring unit 11 has a greater computing time available than is available to the signal processing unit 10 to trigger ventilation strokes. The monitoring unit 11 may be a component of the ventilator 100 or may be arranged outside the ventilator 100. However, it is also possible that the same signal processing device performs both the functions of the signal processing unit 10 and the functions of the monitoring unit 11.
[0140] In one embodiment, the monitoring unit 11 applies a learning method to each temporally last portion of the respiratory signal Sig.sub.res to detect the start and the end of an inspiratory effort. In one embodiment, the learning method is applied to the N temporally last detected inspiratory efforts, where N is a predetermined number. In another embodiment, the learning method is applied to the temporally most recent portion of the respiratory signal Sig.sub.res, where this most recent portion has a predetermined time duration T. In many cases, the application of a learning method increases the reliability with which the respective start and the respective end of the inspiratory efforts are detected in the respiratory signal Sig.sub.res.
[0141] In addition, for each ventilation stroke, the monitoring unit 11 receives from the signal processing unit 10 an identification of those two times at which this ventilation stroke was started and ended, respectively.
[0142] The monitoring unit 11 compares the respiratory signal Sig.sub.res, received or generated by averaging or by any other suitable type of signal processing, which correlates with the patient Pt's own respiratory activity, with the time course of the ventilation strokes performed by the ventilator 100, exemplified by the curve S.100 shown in
[0143] Preferably, the monitoring unit 11 automatically counts how often in the series of situations which asynchrony sequence occurs. In some cases, a certain asynchrony sequence is only relevant if its frequency in the series of sequences is above a predetermined frequency limit or follows a certain occurrence pattern in the series of situations. This applies in particular to the asynchrony sequence [0,1,3] (reverse triggering), i.e. a ventilatory effort triggers an inspiratory effort instead of an inspiratory effort triggering a ventilatory effort.
[0144] As has been explained, the signal processing unit 10 applies a decision rule to detect in the respiratory signal Sig.sub.res the respective start and the respective end of each inspiratory effort. This decision rule depends on at least one parameter. In one embodiment, the monitoring unit 11 automatically assigns a setpoint to this parameter or modifies an already assigned setpoint, depending on how often and/or how long a possible asynchrony sequence has actually occurred. For example, if individual inspiratory efforts are not detected, a lower bound for the volume flow in the decision rule is preferably lowered. Conversely, if individual ventilation strokes are triggered without a corresponding inspiratory effort, this lower volume flow barrier is raised.
[0145] In the embodiment example, the monitoring unit 11 causes the result of the monitoring to be output on the display and control unit 12. In many cases, at least one of the boundary conditions that frequently occur in everyday clinical practice is to be observed, namely that [0146] the display and control unit 12 is relatively small, [0147] nevertheless relatively much information must or should be output, [0148] sometimes there is no optimal lighting and [0149] a user should be able to quickly grasp the presented results, even under high stress and/or stimulus overload, both of which often occur in everyday clinical practice.
[0150]
[0151]
[0152] Quadrants Q3 and Q4 in
[0153] In the example of
[0154] In the example of
[0155] In the two examples shown, the averaged duration in [min] is entered on the x-axis, and the frequency, i.e. number per minute, is entered on the y-axis. It is also possible to use a different measure on the x-axis for how long the asynchrony sequences of the respective type occurred, and on the y-axis a different measure for how seriously an asynchrony sequence affected the supportive artificial ventilation.
[0156] In one embodiment, at least one pneumatic sensor 2, 3, 7, 15 measures a pneumatic measure for the patient Pt's own respiratory activity and/or the assisted artificial ventilation provided by the ventilator 100. The signal from this pneumatic sensor 2, 3, 7, 15 can be used to derive the mechanical effort exerted by the patient Pt's own respiratory muscles (work of breathing) or the pressure integrated over time (pressure-to-product). In one embodiment, the respective mechanical respiratory effort or the integrated pressure is plotted on the y-axis for each asynchrony sequence.
[0157] In one embodiment, an overall rectangle Re is placed around the maximum four individual rectangles for the four asynchrony sequences, cf.
[0158] While specific embodiments of the invention have been shown and described in detail to illustrate the application of the principles of the invention, it will be understood that the invention may be embodied otherwise without departing from such principles.
TABLE-US-00004 List of reference signs 2 Pneumatic respiratory sensor in front of the patient Pt's mouth, measures the airway pressure P.sub.aw and optionally the volumetric flow Vol′, acts as the airway pressure sensor, comprises components 2.1 and 2.2 2.1 Respiratory sensor 2 transducer, taps a gas sample from the fluid connection between the patient Pt's lungs Lu and the ventilator 100 2.2 Actual pressure sensor of the respiration sensor 2 3 Probe in the esophagus Sp of the patient Pt, measures the esophageal pressure P.sub.es and optionally the gastral pressure P.sub.ga, connected to the measuring catheter 6 4 Connector in the patient Pt's mouth, connected to the measuring catheter 6 in the esophagus Sp 5.1.1, Pair of measuring electrodes close to the heart on the patient's 5.1.2 skin Pt 5.2.1, Pair of measuring electrodes close to the diaphragm on the 5.2.2 patient's skin Pt 6 Measuring catheter in the esophagus Sp of the patient Pt, connected to the measuring probe 3 and the connector 4 7 Gastral probe in the stomach Ma of the patent Pt, measures the gastral pressure P.sub.ga 10 Signal processing unit of the ventilator 100, receives measured values from the respiratory sensors 2, 3, 5.1.1 to 5.2.2, 7, generates at least one respiratory signal Sig.sub.res and triggers the respiratory strokes of the ventilator 100 11 Signal processing monitoring unit for the ventilator 100, monitors how well the ventilation strokes of the ventilator 100 are synchronized with the patient Pt's own respiratory activity, generates a series of situations, detects asynchrony sequences in the series of situations and causes a presentation of the asynchrony sequences to be output on the display and control unit 12 12 Display and control unit of the ventilator 100 15 Sensor on ventilator 100, measures the volumetric flow Vol′ 100 Ventilator, artificially ventilates the patient Pt, comprises the display and control unit 12, the signal processing unit 10 and optionally the monitoring unit 11 Atm(1), Breaths detected in the sum signal Sig.sub.Sum . . . , Atm(4) Hz(x), Heartbeats detected in the sum signal Sig.sub.Sum Hz(y) Q1, . . . , Quadrants of an exemplary presentation visualizing the Q4 respective frequency and duration of four asynchrony sequences Re Total rectangle around the four rectangles in the four quadrants Q1 to Q4 S. 100 Schematic time course of the ventilation strokes executed by the ventilator 100 S. Pt Schematic time course of an exemplary respiratory signal correlating with the patient Pt's own respiratory activity Sig.sub.res Pneumatic respiratory signal Sig.sub.Sum Electrical sum signal resulting from a superposition of a cardiogenic signal with an electrical respiratory signal Sig.sub.res and generated from measured values of the measuring electrodes 5.1.1 to 5.2.2