EP1605998A1 - Method and arrangement for the titration of physiological measuring signals in conjunction with the observation of a patient in terms of sleep-related respiratory problems - Google PatentsMethod and arrangement for the titration of physiological measuring signals in conjunction with the observation of a patient in terms of sleep-related respiratory problems
- Publication number
- EP1605998A1 EP1605998A1 EP04721162A EP04721162A EP1605998A1 EP 1605998 A1 EP1605998 A1 EP 1605998A1 EP 04721162 A EP04721162 A EP 04721162A EP 04721162 A EP04721162 A EP 04721162A EP 1605998 A1 EP1605998 A1 EP 1605998A1
- European Patent Office
- Prior art keywords
- method according
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Detecting, measuring or recording for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/087—Measuring breath flow
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0057—Pumps therefor
- A61M16/0066—Blowers or centrifugal pumps
- A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
- A61M16/022—Control means therefor
- A61M16/024—Control means therefor including calculation means, e.g. using a processor
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Detecting, measuring or recording for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7232—Signal processing specially adapted for physiological signals or for diagnostic purposes involving compression of the physiological signal, e.g. to extend the signal recording period
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
- A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
- A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit
Method and apparatus for titration of physiological measurement signals in connection with the observation of a patient in terms of sleep-related breathing disorders
The invention relates to a method and an arrangement for titration of physiological measurement signals. In particular, the invention relates to a method and an arrangement for detecting and evaluating a with respect to the
Respiratory gas flow, a sleeping person indicative measurement signal related to the observation of sleep-related breathing disorders.
For the investigation of sleep-related breathing disorders known. Polysomnographs are known, which usually have multiple measurement channels for detecting measurement signals for physiological state variables of a patient. As is apparent from the returning to the Anrnelderin patent application DE 101 64 445.0, it is known to detect for diagnosis of a patient in terms of its breathing characteristics during a sleep phase ECG and blood pressure signals, and these together with
Signals describing the respiratory activity of the patient record. That the patient's descriptive signals respiratory activity can be generated via so-called. Thermistors or via pneumotachograph. The detected signals can be visualized in temporal association with one another and evaluated under a specialist medical examination. On the basis of specialist medical evaluation can be determined whether any breathing disorders can be prevented by supplying the breathing gas at an elevated pressure level. Appropriate treatment parameters can also be determined as part of specialist medical evaluation.
In the study of individuals with signs of sleep-related breathing disorders viewing the generated test signals in practice may lead to different findings in particular regarding Fashion severity obstruction of relevant properties of the respiratory tract and the general physiological condition of the patient. In case of inadequate evaluation of a disease is the problem that are selected that do not carry the actual physiological needs sufficiently into account, or at least limit the therapy comfort for any necessary treatment conditions.
The invention has the object to provide solutions that make it possible to detect physiological and relevant in terms of breathing during sleep phase characteristics in a way which allows to assess the physiological state of the person under test with high reliability and any necessary treatment framework conditions applicable vote.
According to a first aspect of the present invention, this object is achieved according to the invention, which are by a method for providing a is indicative of the physiological condition evaluation result on the basis of measurement signals with the breathing of a person in connection, wherein from the measurement signals referred to by reference to several, evaluation systems , evaluation characteristics are generated and an evaluation result is generated as part of an based thereon result generation step at least by evaluating characteristics of a linking consideration are subjected, wherein the measuring signals are detected in terms of the applied to the patient's breathing gas pressure level different Titrationssequenzen and generating at least a part of the evaluation of characteristics takes place or the evaluation outcome taking into account the respective Titrationssequenzdruckes.
This makes it possible in an advantageous manner, as part of an approximately 6 to 8 hours continuous patient monitoring from a regard to their
Meaningfulness to collect data amount advantageous captured evaluation features from which high informational value in a standardized repeatable manner evaluation results can be obtained, which can be used advantageously for the configuration or map vote of any required positive pressure ventilation system, or a medical diagnosis can be based and a contribute to a standardized assessment.
The term of Titrationssequenzdruck applied to the patient's static pressure of the breathing gas is to be understood. The term titration sequence a Titrationsabschnitt is meant that can be defined, for example in terms of its duration, a certain number of breaths or otherwise with respect criteria. Advantageously, it is possible to keep the Titrationssequenzdruck within a titration sequence substantially constant.
Alternatively, or selected sequences, it is also possible to perform the Titrationssequenzdruck within a titration sequence for a DruckführungskonΣept which provides, for example, weak alternating or following a bi-level concept target pressure settings. The setting or management of the pressure within a titration sequence can be performed adaptively according to the selected adaptation criteria. However, the pressure adaptation is carried out preferably such that are allowed within a titration sequence occurring pressure changes only in a range that is less than the average distance of the pressure of successive Titrationssequenzen.
The temporal length of the Titrationssequenzen is preferably determined by the sequence length criteria. This sequence length criteria can include both minimum length and maximum lengths. It is possible to provide several sequence length criteria, the fulfillment of which it depends whether a change in a subsequent titration sequence or validation sequence should not take place.
In order to avoid too short Titrationssequenzen at least a minimum time period and / or a minimum breathing number is preferably set in the form of a sequence length criterion. It is also possible to provide waiting times in each, or at least in selected Titrationssequenzen, whereby it is possible to neglect at least for certain evaluation operations, the measurement signals acquired within the waiting time to process with a reduced priority or undergo certain verification procedures. This makes it possible for any reactions caused by the pressure change improved to take into account.
It is possible to match the sequence length dynamically, so that upon the occurrence of specific character during the run of a titration sequence it can be shortened or lengthened. Depending on the occurring during the running characteristics, it is possible to change the priorities of the sequence length criteria dynamically, or temporarily turn off further sequence length criteria (priority 0). The fulfillment of examining the sequence length criteria may also include checks for obstruction indicators.
The change from a titration sequence to the next titration sequence can be made dependent on otherwise indexing criteria.
Preferably, however, provision is made such that a predetermined minimum number of individual TitrationssequenΣen is processed.
According to a particular aspect of the present invention, the pressure is within a guide TitrationssequenΣ to the detection of certain
Indicators tuned such that these indicators may be detected with high informational value. Preferably apnea indicators hypopnea indicators and Flusslimitationsindikatoren be evaluated.
The control of the Titrationssequenzen is preferably carried out according to a sequence management concept. This sequence guide concept is preferably at least one period before successively increasing pressure levels, and a period successively decreasing pressure levels.
It is also possible to design the sequence management concept that this provides more Titrationssequenzen with different Titrationssequenzdrücken, wherein under the control of these Titrationssequenzdrücke intermediate phase pressures are controlled in which the breathing gas pressure level is at a level which is higher than the Titrationssequenzdruck a previous titration sequence and a subsequent titration sequence. The intermediate phase pressures are in this case preferably in each case at the same pressure level, particularly preferably on a suitable therapy expected pressure level.
The sequence management concept may be configured so that this extends over a plurality of period Titrationssequenzen containing as well as a Validisierungperiode. It is also possible to limit the application of the sequence management concept for the respiratory gas pressure control to a titration serving period and to connect those Validisierungsperiode to them. The length of time of those of the titration serving period can be defined as a function of certain generated contact following evaluation results, or - to be fixed - at least in terms of a minimum and maximum duration.
The pressure setting within the Validisierungsperiode based advantageously on the previously obtained evaluation results. The pressure guide is preferably chosen such that there are no significant pressure fluctuations within the Validisierungsperiode.
In the context of Validisierungsperiode preferably an adjustment is made or a plausibility check of the evaluation results as well as a qualifying examination of a patient-specific print control configuration.
In a particular aspect of the present invention generated during the individual Titrationssequenzen evaluation characteristics of a linking consideration are subjected wherein the for the linking viewing link time window is preferably larger than that of the time window in which the relevant for the evaluation of characteristics measurement signals are processed to the evaluation of characteristics.
By evaluating individual Titrationssequenzen it is possible in an advantageous manner to generate particularly indicative Evaluation criteria for the respective respiratory gas pressure level and to lay the so determined properties of the breathing within a titration sequence of the evaluation features several Titratiossequenzen linked contemplative evaluation and Gnerierung the evaluation results based.
The Titrationskonzept present invention can provide setup parameters for the
Configuration of a pressure control means of a
Pressure ventilation device, in particular a CPAP device.
According to a particularly preferred embodiment of the invention, a physiological typing of the optionally existing disease of the examined person is made on the basis of the present invention generated evaluation results. On the basis of the present invention generated evaluation results, it is possible to optimize the control response of an intended for controlling the respiratory gas pressure pressure control device automatically, so that for example after a period of use of only one night, the control behavior of the pressure control is already tuned applicable to the patient. The vote can be validated as part of the monitoring night. The required electronic components can be integrated into a patient device.
According to a particularly preferred embodiment of the invention, a configuration data set is based on the linking viewing generated, the configuration of the breathing gas pressure control of a therapy device, in particular a CPAP device. The configuration record can an interface device, or advantageously also by a mobile
Data carriers are transmitted in the form of a memory stick, or a PCMCIA card on the therapy device CPAP device. The configuration record may be modified, if necessary, with the interposition of an adaptation procedure, that this particular system characteristics of a non verwendetren for titrating CPAP device carries particular account. It is also possible to carry out the investigation according to the invention with subsequent validation directly to a patient device, wherein preferably provided for the execution of the pressure control device to a control concept according to the invention Schnittstelleneinrichtng of the patient device is docked. It is also possible that provided for the execution of the pressure control and measurement survey inventive concept
to use control means, if necessary, with interposition of a power circuit for control and power supply of a pneumatic conveyor of the patient device. It is also possible to cause the patient device, or intended to carry out the examination apparatus for controlling the desired pressure level by a mask pressure measuring device - is applied, for example, via mask pressure probe with varying pressures.
According to a particularly preferred embodiment of the invention, the evaluation characteristics are generated on the basis of correlation criteria which, for example, common with the previous breaths, or breaths reference rate. The correlation criteria can in particular also to the first and / or second derivative of the detected
Respiratory gas flow to be applied. A generation of the characteristic of the respective breath features can be done using statistical methods. The linking consideration of the determined characteristics for each breath can be done using statistical methods.
On the basis of the generated within a titration sequence for each breath or breath certain consequences evaluation characteristics, a feature array can be filled successively from which messages can be read in accordance with selected join criteria.
The evaluation characteristics are generated according to a particularly preferred embodiment of the invention is such that there are, for example, under these evaluation characteristics, the characteristic with regard to the information concerning the duration of a breath and / or for example as normally to be regarded breaths
Information contained. Based on this analysis features, it is possible to determine the temporal length of periods with normal breathing, as part of the linking consideration. According to a particular aspect of the present invention, a determined contained in the evaluation features characteristic contribution within a time window that is smaller than one, provided for viewing the linking link time window. This makes it possible in an advantageous manner, a high resolution for one breath typical properties within
Contemplation of the breath to detect and to subject the thus established characteristics of the breaths of a plurality of breaths taken into account consideration.
The evaluation inventive concept may find supplied breathing gas use in controlling the pressure of the patient by means of a positive pressure breathing system. This is possible to precisely tune the breathing gas pressure on the current physiological needs of the patient without affecting the sleep history by a subjectively perceived to be incorrect high control dynamics.
The linking consideration of the breath properties determined for the individual breaths may be over a time window extending for example, a predetermined, for example, 30 breaths or adaptively optimized number of breaths overlooked. In particular, for the assessment of the physiological condition of the patient, for example as a basis for a medical diagnosis, it is also possible, certain logic operations to carry out extensive time window for phase-related sleep periods selected time portions or the entire measurement. According to a particularly preferred embodiment of the invention selects a particularly reliable generation of characteristic parameters esp. Indices on the basis of logic operations raw and / or intermediate results allow.
According to a particularly preferred embodiment of the invention, a physiological typing of the optionally existing disease of the person being examined on the basis of the linking consideration. On the basis of the present invention generated evaluation result, it is possible to optimize the control response of an intended for controlling the respiratory gas pressure pressure control device adaptively, so that for example after a period of use of several days, the control behavior of the pressure control is optimally matched to the patient.
According to a particularly preferred embodiment of the invention will be on the
generated based on the linking viewing a set of configuration data, the configuration of the breathing gas pressure control of a CPAP device. The configuration record can be transmitted via an interface device, or in an advantageous manner by a mobile storage medium, for example in the form of a PCMCIA card to the CPAP device. Of the
Configuration data set can be modified, if necessary, with the interposition of an adaptation procedure, that this particular system characteristics of the CPAP device carries particular account.
According to a particularly preferred embodiment of the invention, the
Evaluation criteria generated based on Korrelationskriferien particular statistical evaluation systems by which, for example, common with the previous breaths, or, preferably, adaptively optimized criteria reference for example be rated for reference breaths. The Korrelationskriferien can in particular to the first and / or second
Derivative of the sensed respiratory gas flow are applied. A generation of the characteristic of the respective breath features can be done using statistical methods. The linking consideration of the determined characteristics for each breath can be done using statistical methods.
On the basis of the generated for each breath or certain breath consequences evaluation characteristics, a feature array can be filled up successively, and this feature field describes a window of time at least for selected evaluation characteristics which is at least as large as the smallest, provided for linking consideration of evaluation characteristics link time window. The evaluation characteristics are generated according to a particularly preferred embodiment of the invention is such that there are, for example, under these evaluation characteristics, the information concerning the duration of a breath and / or contain, for example with respect to a normal to be regarded breaths characteristic information. Based on this analysis features, it is possible to determine the temporal length of periods with normal breathing, as part of the linking consideration.
Furthermore, the evaluation characteristics are also generated in an advantageous manner such that the occurrence of these phenomena any flow limation preferably also certain individual in breathing, flow limitation with respect to the representative information included. On the basis of a linking viewing of said captured for such a flow-limited breaths evaluation characteristics, it becomes possible to describe the duration of certain properties of at least partially flow-limited breath sequences.
For periods where no breathing activity is detected, evaluating features may also be generated based on which the phase length of any ApnoesequenΣen and / or for properties of these apnea phase characteristics can be generated as part of the linking consideration. This evaluation characteristics preferably include information concerning the type of apnea, for example, whether the phase apnea is classified as central, obstructive or as a combination (mixed apnea phase).
Such evaluation of characteristics are generated according to a particularly preferred embodiment of the invention also for snoring phases of phases with Cheyne-Stokes breathing and hypoventilation phases.
In the evaluation features and specifications or information are preferably contained from which the body position, head position, and preferably also the neck twist level of the patient can be derived. Already in the evaluation features schlafphasenindikative information may be included.
The evaluation of characteristics generated are preferably stored in association with the detected breath, or taking into account their position in time. Ie the generated evaluation features a defined time windows are - in the case of normal breathing assignable each breath.
In the context of linking consideration that flow limitation, hereinafter referred to as Flusslimitationsindex index is generated according to a particularly preferred embodiment of the invention, a classifying. This Flusslimitationsindex can be determined based on the following evaluation rule, for example:
Calculation of titrationsintervallspeΣifischen Flusslimitations Index (FLI (p)):
Flip = index indicating the flow limitations per Dracklevel A = number of flow-limited breaths interval t = time duration of a titration sequence.
Alternatively - or in combination herewith, it is also possible to determine an indication of the Flusslimitationspotential characterizing eg size designated in the form of a hereinafter referred to as Flusslimitations ratio (FLR).
Calculating the Flusslimitations ratio (FLR):
- flow limitation
FLR, _ * 100% =
wherein: FLR; = Proportion of the flow-limited inspiratory time per effectively breathed inspiration time t F l USSL i m i tat i on = inspiration time of the flow-limited breaths t I nterv ll = total inspiration time of a time interval (in hours); the time interval results, for example from a pressure stage,
Sleep phase, etc.
With the help of Flis and FLRs flow-limited breathing can be brought into various dependencies and the applied pressure therapy can be evaluated.
The calculations for flow limitation made on the basis of the detected breathing gas flow rate:
• Detection of respiratory phase that is recognition of the expiratory phase of respiration and inspiration
• Determination of the inspiratory time
• Review of breaths depending on: the Atmregelmäßigkeit by the reverse correlation, for example, stable or unstable breathing
Zeitinvertalle, for example, 5/10/30/60/90 min pressure levels, for example, AI 5 ... 1617 mbar
Sleep stages, for example, wax, REM, NREM 1-4
Sleep quality, for example on the type of detected events such as apneas, hypopneas
General by the number of detected faults
Body position, such as supine position, lateral position breath features, eg inspirative / exspiratives tidal volume, max. in / exsp.- flow rate, respiratory rate, different temporal relationships between Inspiration / Expiration / and / or
Total length breath, respiratory rate change Krümmungsändβrung, index change
Geasmtatemzugslängenänderung, and total breath length.
The relationships you create can be entered into a table and then analyzed.
Review of breathing with features
Furthermore, it is possible to generate a snoring index as part of the linking consideration. The zoom drawn for the determination of snoring signal sequences can be generated from the respiratory gas pressure detecting means, from the motor power reference, as well as from the respiratory gas flow signal, or in particular acoustic sensing systems. Furthermore, it is possible to generate a respiratory mouth / nasal breathing index as part of the linking consideration. Furthermore, it is possible to generate a sleep time index within the linking consideration.
Furthermore, it is possible within the framework of the linking viewing a
generate sleep phase index. It is possible in connection with the respiratory phase observation between inspiratory
to distinguish (obstruktionsrelevantem) and expiratory (minderrelevantem) snoring. Furthermore, it is possible to generate a periodic breathing index as part of the linking consideration. Furthermore, it is possible to generate a tidal volume index in the frame of the linking consideration.
The evaluation features may apart from information on the position of the body is preferably a designated hereinafter referred to as v-measurement based on
Volume flow measurement of respiratory gas flow to be generated. The measurement of the Afemgasstromes can be carried out at ambient pressure or under defined altered respiratory gas pressure.
At least part of the evaluation features is preferably
Considering the first or second derivative of the temporal course of the respiratory gas flow generated.
According to a further aspect of the present invention, the above-mentioned object is also achieved, in which the measuring signals said generated by an apparatus for performing the method described above, which device comprises a measuring signal input device and a computing device for providing a plurality of evaluation systems by the evaluation system, analysis features and be under a result based thereon generating at least one step
is generated evaluation result by the computing means is configured such that it subjects the evaluation of characteristics of a linking observation and the measurement signals are acquired in regard to the applied to the patient's breathing gas pressure level different Titrationssequenzen and generating at least a part of the evaluation of characteristics and the evaluation outcome made in consideration of the respective Titrationssequenzdruckes.
As part of the acquisition of the patient's respiratory activity on the basis of indicative of the respiratory gas volume flow data, it is possible to identify individual breaths as such. The beginning and end of the home and Expirationsphasen of the breath may be determined, for example, in connection with an examination of the first and second derivative of the respiratory gas flow signal and taking into account the possible tidal volume.
Based on these evaluation results, the time duration of the breath phases of the actual volume of the breath and the breath sample can be determined.
By a statistical analysis of the properties of several sequence Direction
Breaths within a titration sequence, the current physiological state of the person under test can be further determined. a raw data reduction can be achieved based on the extraction of features for each individual breath within the titration sequence. From the statistical analysis of the properties of several successive breaths can distinguish between snoring and obstruktionsrelevantem obstruktionsunrelevantem snoring. A typing
Oscillation characteristics associated with snoring events can take place, dispensing with a microphone device.
The occurrence of any snoring induced oscillations can be detected from the time characteristic of the respiratory gas pressure. So it is for example possible to extract caused by snoring breathing gas pressure oscillations from, generated by corresponding respiratory gas pressure sensor means signals. In particular, based on a frequency and amplitude analysis such as Fast Fourier analysis, it is possible to classify snoring events with regard to their place of origin (soft palate, larynx ...). As part of a statistical evaluation of-sequential breaths, it is possible to generate an indicative terms of respiratory stability breathing index for each titration sequence. This breathing index is determined preferably by the following rule:
Calculation of respiratory index (At-I) for each titration sequence:
- Interval M
At-I = index which indicates a certain type of breathing patterns such as unstable, stable breathing, mouth breathing, nasal breathing per hour A = number of specific breathing patterns such as unstable breaths t Inter all = time of the measurement interval in hours; the time interval results from eg a pressure stage, sleep phase, etc.
With a stable breathing is present when the respiration stability index is> 0.9 and an unstable breathing is considered to be present when the respiration stability index is <0.9.
Based on the linking consideration of evaluation characteristics, the following obstructive disordered breathing (OSA) can be recognized in particular:
Apnea, hypopnea, flow-limited breathing, stable and unstable breathing and any leakage events.
A respiratory disorder is classified as an apnea event when a respiratory standstill is detected, the length of which exceeds a predetermined time period, for example 10 seconds.
A Hypopnoeereignis can be considered to be present if for example be recognized as normal classified breaths, at least two and up to three more breaths after three. A further criterion for this is the difference inspiratory volume of the considered breaths can be used.
In each case studied, a breath flow limitation can be detected when the respiratory gas flow during the inspiratory phase plateau certain zones or more maxima.
A stable respiration can be considered to be present if the respiratory flow or the respiratory frequency and the amplitude of the respiratory gas flow within a predetermined time range can be considered as regular. Breathing can in particular be considered to be stable when a, defined for the respiratory stability respiratory stability index, has a magnitude of> is the value of 0.911. While a stable breathing no breathing movements occur (OSA).
Unstable breathing can then be considered to be present if the above-mentioned respiratory stability index has a value that is less than 0.911, and the respiratory flow is correspondingly irregular.
Such irregular breathing may be classified as respiratory disorder, wherein for such phases in case of a respiratory gas pressure control, this is done with an increased sensitivity.
Any occurring in a pressure signal high frequency oscillations can be klasssifiziert as domestic or expiratory snoring in communication with the respiratory flow signal. The analysis features generated by snoring for the occurrence can be incorporated in the intended for generation of the evaluation results linking consideration.
Based on the time course of the nasal breathing gas communicated
Volume flow can also system states such as variants of breathing gas flows faulty (leakage), for example caused by artifacts mask application (mask problems) or expiratory breathing through the mouth, as well as permanent oral breathing to be classified. In case of leakage of the time profile of the nasal communicated respiratory gas flow is a displacement amount-relative to a reference value (eg zero line). In the case of expiratory breathing through the mouth between the inspiratory volume and the expiratory volume, as takes place at least a portion of the gas exchange orally. Other key features are the slope of the
Inspiration / Exspirationsflanke, the relative time position of the extreme values in the respective respiratory phase.
When using the services of the present invention have made the generation of evaluation results on the basis of a linking viewing
Evaluating features within a titration sequence taking into account the associated Titrationssequenzdruckes, for controlling the respiratory gas pressure, it is possible, for example, tune devices operating paramenter as the switching characteristics of a pressure control between different Druckregelmodis. So the evaluation results obtained can be set, for example, on the basis of which criteria a breathing gas pressure control is to take place under a standard dynamic or higher "Sensitive dynamics."
The control behavior of the pressure control means is adapted to normal or standard dynamic mode is preferably such that any recognized
Allow events or defined event chains an increase in pressure. in the
A so-called frame. Sensitive mode the respiratory gas pressure can be gradually decreased incrementally, the system may be adjusted such that is reacts to any, occurring at lower respiratory gas pressure events with a higher control dynamics. A change in the sensitive mode can be made dependent on several criteria, in particular depending on whether a stable breathing is present (respiration stability index> 0.911). Of the
Operation of the apparatus under the above-mentioned rule criteria is carried out in an advantageous manner after completion of the titration during the Validisierungsphase.
During normal mode, the control behavior of the pressure control means is preferably adjusted so that an increase in pressure then occurs when apnea conditions or Hypopnoezustände flow limitations are recognized. In the case of apnea two sequences having relatively large length of time or for example also in the case of three phases of apnea with a shorter period of time, it is possible to gradually increase the breathing gas pressure. An increase in the respiratory gas pressure can also take place when a respiratory arrest over a predetermined period of, for example,
1.2 minutes is detected. The increase in breathing gas pressure can be carried out continuously or stepwise, wherein the Drucksteigerungsgradient preferably does not exceed a maximum of 4 mbar per minute. It is possible to provide a minimum pressure limit in the range of 4 to 10 hPa and a maximum pressure point in the range 8 to 18 hPa. For one
Algorithm starting pressure is preferably provided a pressure in the range 4-8 hPa. In the case of detected Hypopnoezustände preferably takes place a pressure increase in a comparatively small pressure stages, for example, 1 mbar, and preferably the number is limited to pressure increasing steps.
In the case of Flusslimitationsphasen at a respiratory stability index of> 0.911 a pressure increase to pressure increments of 1 mbar can be made. A pressure decrease can be carried out if, within a predetermined time window, for example, 9 minutes, a stable breathing is detected and the respiratory stability index has a value of> 0.911. In this case, a pressure reduction may be allowed by example 2 mbar. It is also possible to suppress a change in the respiratory gas pressure for predetermined periods of time or be limited to a comparatively narrow change in pressure corridor. Conducting a pressure change can be, for example, then stopped when a certain combination of criteria present at which breathing is classified as unstable and, inter alia, the respiratory stability index <0.91. 1
An operation of the respiratory gas pressure control in the sensitive mode causes a pressure increase takes place when apnea conditions occur in accordance with a predetermined time response. So it is for example possible to cause a pressure increase of 2 mbar when either a respiratory arrest with a duration of more than two minutes is detected or two large (min. 25 See.) And three smaller apnea states (max.25 lake.) are detected and the respiratory gas pressure is in this case less than 14 mbar. A pressure increase to a value of 1 mbar can be caused when Hypopnoesequenzen occur over a time period of at least 3 minute period.
Pressure increases by 1 mbar are then caused in the sensitive mode when show A A breaths Flusslimitationsmerkmale and respiratory stability index is> 0.87 or B from C breaths River Limitationsmerkmale show and respiratory stability index is> 0.911 or C from D breaths Flusslimitationsmerkmale show and
Respiration stability index in this case likewise> 0.96.
A reduction in pressure is preferably then causes the Sensitv mode if a stable respiratory present and the length of time for this stable breathing is at least three minutes and at the same time the respiratory stability index> 0.911 is. In this case, a pressure reduction from initially 2 mbar can be initiated. In the sensitive mode, it is preferably also possible, in phases to allow any pressure change or to limit the pressure change to a relatively narrow pressure change corridor. Preferably no pressure changes are approved especially if breathing is classified as unstable and obstruction conditions are detected.
A Hypopnoephase can be considered to be present if, and when at least two follow after three normal breaths up to three more breaths. Here, an inspiratory volume difference .DELTA.V must be present that exceeds a predetermined limit (eg 50% of the average tidal volume).
Based on the consideration of the invention in terms of
Respiratory gas flow signal indicative it is possible to detect breathing disorders at least initially require any change in respiratory gas pressure. Such breathing disorders may be: swallowing, coughing, mouth breathing, expiratory mouth breathing, arousals and speaking.
The detection and evaluation of the invention indicative of the respiratory gas flow signals can provide information to describe and
provide visualization of the physiological state of a person especially with regard to a related with sleep-disordered breathing disorder. The signal detection and evaluation of the invention can be used for configuration of ventilators. The signal detection and evaluation of the invention may continue to
Realization of a breathing gas supply apparatus, in particular a positive pressure ventilation device to be used with self-tuning control pressure.
According to a particular aspect of the invention two of the following information is at least employed in combination:
- the breathing gas pressure is adjusted in such a way during an examination night that first a titration phase followed by a validation phase is processed.
- During the titration period, the pressure guide is carried by a pressure guide the concept meaningful to the detection possible and true respiratory gas flow signals is designed.
- The pressure control during the titration phase is done in a standard by Titrationsprozedurkriterien in a repeatable manner.
- The Titrationsprozedurkriterien are designed for the detection of measurement signals that enable an assessment or classification of the physiological condition of the patient with high statistical certainty.
- The degree of confidence determined assessment or classification results is determined.
- For every breath breath-specific characteristics are determined on the basis of defined analysis procedures.
- the analysis procedures take particular account of the inspiration operation, the Expirationsvorgang, the transition between said operations, the curve characteristics of the respiratory gas flow curve within each breathing cycle considerations combination of features of the respiratory gas flow path within a breath.
- The similarities of breaths are determined. - differences or temporal changes of breath characteristics are determined and taken into account in assessing the physiological state of the patient.
- from a multi-linked consideration of individual characteristics evaluation results are generated which describe standardize parametrically a physiological condition or physiological properties.
- The pressure guide during the titration is performed in such self-regulating, that the physiological state of the patient is detected with high informational value.
- The pressure guide during the titration is performed in such self-regulating, that the physiological state of the patient with high
Titrafionskomfort is determined.
- The pressure guide during the titration is performed in such self-regulating, that the physiological state of the patient is determined with the least possible amount of time. - The pressure control or pressure settings during the validation phase is carried out in such a self-regulating, that the plausibility of a respiratory gas pressure control concept determined, in particular the plausibility or accuracy of a determined pressure CPAP therapy with high statistical security is checked. - There are interim analysis results according to a defined
- The standard above mentioned is adjusted so that this conversion of the intermediate evaluation results in other preferably standardized parametric patient characteristics such as respiratory elasticity airway occlusion pressure,
allows Atemwegswiderstandsbeiwert, maximum inhalation flow rate, maximum Exspirationsvolumenstrom, and hyperventilation security. Further details and features of the invention will become apparent from the following description taken in conjunction with the drawings. Show it:
Fig.la is a time chart for explaining a more comprehensive Titrationssequenzen titration period, wherein the time duration of the individual
Titrationssequenzen is dynamically tuned,
FIG. 1b is a timing chart for explaining a second variant of the invention with regard to their titration period predetermined Titrationssequenzen,
FIG. 1c is a timing chart for explaining a portion of a
Titration with several Titrationssequenzen, wherein the
Titration is lowered from a high pressure level, starting gradually, the time length of the individual stages by
With a printing management concept is fixed,
Fig. 1d shows a detail of one divided into several TitrationssequenΣen titration period,
Fig. 1e is a time chart for explaining a portion of a
Titration with several Titrationssequenzen, wherein the
Titration is raised from a low initial pressure level, starting gradually, whereby between each pressure increase is a temporary lowering the pressure to a pressure level which is between the output pressure level of the preceding pressure stage and the target pressure of the preceding pressure stage;
Fig. 1f is a time chart for explaining a portion of a
Titration with several Titrationssequenzen, wherein the titration is raised from a low initial pressure level, starting gradually, taking place between each pressure increase, a temporary reduction in pressure to a pressure level which is between the output pressure level of the preceding pressure stage and the target pressure of the preceding pressure stage; wherein the pressure change occurs over a opposite demDruckführungskonzept 1e of FIG more elongated period of time.
Fig. 2 is a chart for explaining the pressure guide in a calibration mode, in the titration, as well as in the validation mode.
Figure 3 is a diagram for explaining an arrangement according to the invention for the inventive Signaltitration.
FIG. 4a is a diagram for explaining the respiratory gas flow for a single breath;
FIG. 4b is a diagram that describes the timing of the respiratory gas flow for several breaths;
Fig. 4c is a graph illustrating the time course of the respiratory gas pressure with individual pressure oscillations caused by snoring;
Fig. 4d is a diagram illustrating the time course of breathing gas Fromes for several interrupted by an apnea period breaths;
Fig. 5 is a graph illustrating the time course of respiratory gas flow with a Hypopnoeereignis;
6 is a diagram of the time courses of the respiratory gas flow for a plurality of flow-limited breaths part.
Fig. 7 is a diagram illustrating the time course of
Respiratory gas flow in the case of a substantially undisturbed, stable breathing; 8 is a diagram for explaining the temporal course of the respiratory gas flow in case of an unstable disordered breathing.
Fig. 9 is a diagram of the temporal course of the respiratory gas flow and at the same time association represents the course of this, the respiratory gas pressure which occur in the Drucksignaloszillationen caused by snoring;
10 shows a diagram of the temporal course of the respiratory gas flow in the event of a system malfunction for example, by mouth breathing or
Mask leaks caused represents;
Figure 11 is a diagram for explaining a led in connection with the detection and associated viewing of breathing patterns of breathing gas pressure change;
Figure 12 is a diagram illustrating the time course of the respiratory gas flow and based upon this change made the respiratory gas pressure;
Figure 13 is a diagram illustrating the time course of the respiratory gas flow, in conjunction with a prompted on the basis of this respiratory gas flow breathing gas pressure change;
Figure 14 is a diagram illustrating the time course of
Respiratory gas flow in conjunction with a basis thereof caused change in the respiratory gas pressure;
Figure 15 is a diagram illustrating the time course of the respiratory gas flow with therein recognized Hypopnoesequenzen and caused based on the detection of these Hypopnoesequenzen breathing gas pressure change; Figure 16 is a diagram illustrating the time course of the respiratory gas flow, with flow-limited breaths occurring therein as well as a graph for explaining the case set breathing gas pressure;
Figure 17 is a diagram illustrating the time course of the respiratory gas flow, in conjunction with the respiratory gas pressure prevailing in this case;
Figure 18 is a diagram illustrating the time course of
Respiratory gas flow with a normal breathing phase occurring therein, a phase flow limited respiration, a subsequent Hypopnoephase to it and caused by a mask leakage faulty phase in connection with the case prevailing respiratory gas pressure;
Figure 19 is a diagram illustrating the time course of the respiratory gas flow, in conjunction with the respiratory gas pressure prevailing in this case;
Fig.20 a diagram for explaining the time profile of the respiratory gas flow for a normal breathing sequence and an adjoining sequence with additional mouth breathing;
21 shows a diagram for explaining the generation of the specific terms of the physiological condition of a patient evaluation result on the basis of measurement signals related to the breathing of the person in a connection, wherein the measurement signals mentioned evaluation characteristics are generated from by reference to a plurality of evaluation systems, and
A frame based thereon result generation step at least one evaluation result is generated by evaluating characteristics of a linking consideration are subjected. Figure 1a shows the greatly simplified over successive abfolgende Titrationssequenzen 1, 2, 3 changes of the pressure via a breathing mask arrangement applied to a patient's respiratory gas. The set breathing gas pressures are in this example in a range which extends from 3 mbar to 16 mbar. The total duration of here divided in the Titrationssequenzen 1, 2, 3 titration period P is in this embodiment 5 hours.
By successively activating with respect to the applied to the patient
Breathing gas pressure level different Titrationssequenzen it is possible to extract from the respiratory gas flow signal evaluation characteristics and generate evaluation results of these evaluation characteristics in the framework of a linking observation that allow, for example, a determination of an effective CPAP pressure or can contribute to the typing of a possibly present disease to the.
That, in the illustrated embodiment is decisive for the stress management stress management concept is in this variant that every single TitrationssequenΣ includes a waiting sequence and only after this
WartesequenΣ the Atemgasfluss- or respiratory gas pressure signal is considered. In this embodiment, the duration of each Titrationssequenzen is defined by boundary values, where a transition into a subsequent titration sequence can also be performed upon fulfillment of a predetermined indexing criteria within these boundary values. these
Next switching criteria are in particular to criteria that provide evidence of whether the current breathing can be classified as impaired. Provided that the instantaneous breathing may be classified as defective, in response to sensed fault characteristics, the remaining period of the current titration sequence and / or the pressure jump to the next
Titration sequence are set. As pressure-disordered breathing can particularly apnea events, hypopnea events and Flusslimitationsereignisse be used. The preferably set by the wait time minimum duration of each Titrationssequenzen an unacceptably rapid increase in the respiratory gas pressure is avoided. It is possible to evaluate the flow of breathing gas to the patient during the information contained in the individual Titrationssequenzen waiting periods. The evaluation of characteristics determined by evaluation of the respiratory gas flow within the waiting time may in particular the further
Signal processing are used as a basis when breathing after the waiting time meets predetermined criteria.
1b shows the waveform of the breathing gas pressure is shown within a titration period P, wherein the respiratory gas pressure here as in the
Embodiment of Figure 1 in stages over abfolgende Titrationssequenzen 1, 2, 3 .... is increased away. The print area extends in this embodiment, from a minimum pressure of about 3 mbar starting up to a maximum pressure of 16 mbar. In the embodiment shown here, the time duration of each individual titration sequence is rigid and fixed independently of the instantaneous breathing gas flow. That is, the pressure is increased successively in preferably constant time intervals.
Figure 1c also shows the changed according to a further variant of the DruckführungskonΣepts during a Titrationszeitraums breathing gas pressure in the form of a time / pressure graph. According to the illustrated pressure guide concept applied to the patient's respiratory gas pressure is set at the beginning of the titration period to a plausible maximum pressure of for example 16 mbar. Over a number sequence Direction Titrationssequenzen 1, 2, 3 across the respiratory gas pressure is gradually lowered to a level of 3 mbar up to the end of the titration period P.
Figure 1d shows the time course of the respiratory gas pressure in accordance with a fourth variant of a pressure guide the inventive concept for a titration period P. According to the processed here pressure guide concept is carried out starting from a high breathing gas pressure level lowering the breathing gas pressure to a predetermined titration, wherein between the individual Titrationssequenzen 1, 2, 3 a return is made respectively for a predetermined period of time to the increased output pressure level. The duration of the titration period P shown here, may for example be 3 to 5 hours. The temporal length of each Titrationssequenzen is preferably about 18 - 32 minutes. The change of the respiratory gas pressure between the-sequential Titrationssequenzen or return to an intermediate pressure level may be gradual spread over several breaths. It is possible that
make change of the breathing gas pressure such that pressure increases in particular, only in certain respiratory phases, for example, during Expirationsphasen.
Figure 1e shows a time chart for explaining a portion of a
Titration with several Titrationssequenzen, wherein the titration is raised from a low initial pressure level, starting gradually, taking place between each pressure increase, a temporary reduction in pressure to a pressure level which is between the output pressure level of the preceding pressure stage and the target pressure of the preceding pressure stage. The individual TitrationssequenΣen t1, t2 ... tn can respect their time, be set to the number of breaths to be examined or otherwise Titrationssequenz- length criteria. The pressure changes between the individual pressure stages take place relatively quickly, preferably within the transition from the inspiratory to the expiratory phase. After completion of the
Pressure stages having titration period TP A validation phase VL in which a respiratory gas pressure is set which is determined during the titration phase on the basis of evaluation results, is determined and is evaluated with regard to its plausibility by further assessment features.
Figure 1f shows a time chart for explaining a portion of a titration with several Titrationssequenzen, wherein the titration of a low initial pressure level is starting is raised stepwise, which occurs between each pressure increase, a temporary reduction in pressure to a pressure level between the output levels of the preceding pressure stage and the target pressure preceding pressure stage is located; wherein the change in pressure via a pressure against the guide concept of Figure 1e more elongated period of time. The respective pressure change preferably takes place over about 10 to 15 breaths stretched. The further elaboration on 1e shall apply mutatis mutandis.
Figure 2 shows in four levels divided details of a calibration mode and the titration described above in a four variants according to the invention provided below therapy mode.
During the titration previously performed calibration, a calibration of the measuring arrangements, in particular the
carried sleep laboratory systems and a basic configuration of an electronic evaluation system. This calibration can extend over a period of for example 30 minutes and preferably be automatically terminated as soon as a self diagnosis procedure can be properly classified as the detection system. The calibration of the measuring arrangements for detecting the respiratory gas pressure as well as the respiratory gas flow is preferably when applied on the patient side breathing mask arrangement.
Upon completion of the calibration mode by the DruckführungskonΣept the
causes introduction of the titration. Under this titration mode the respiratory gas pressure can be changed by successively abfolgende Titrationssequenzen away gradually, as has been explained above with reference to Figures 1a to 1d by way of example. As part of the titration the instantaneous course of the respiratory gas flow is preset using
Evaluation criteria analyzed. By applying these evaluation criteria can be generated for each Titrationssequenzen and especially for a case controlled pressure levels Evaluation criteria. This evaluation features can be stored in a data field. By a brief summary of the evaluation processing characteristics determined indicative evaluation results can be generated with respect to a possibly present disease. When generating the evaluation characteristics are preferably described by an analysis of the flow of breathable gas and the respiratory gas pressure as well as preferably also in relation Another polysomnographic parameters such as the blood oxygen saturation level, body position of the patient as well as EEG, ECG, and / or EOG signals breathing disorders.
Configuration information, a mode of therapy is carried out after the proviso following the titration will be determined on the basis of the obtained evaluation characteristics and the evaluation results derived therefrom.
This mode of therapy is adjacent to the above-described titration. As part of the therapy mode, the breathing of the patient, in particular by evaluating the respiratory gas flow signal and the breathing gas pressure signal could be monitored. Based on the
Monitoring results it is possible to check the plausibility of the settings determined in the context of the titration. Furthermore, it is possible to describe by evaluating the measurement signals collected under the therapy mode and the quality of therapy.
The titration can be carried out in particular so that a required for a GPAP therapy and validisierter CPAP pressure is determined by this still following the titration. In this case, the treatment mode can be performed such that is increased by means of a pressure control device of the present at the patient's breathing gas pressure to a certain pressure management concept for several Titrationssequenzen away gradually. The pressure increase can be effected by a rigidly predetermined time scheme, or also due to ongoing analysis is indicative of the patient's respiration signal.
It is also possible to lower the applied to the patient's respiratory gas pressure from a high pressure level at which, as expected, no expected respiratory disorders occur over successive abfolgende Titrationssequenzen to a predetermined minimum level. It is also possible to apply the pressure management concepts described above combined. Thus the pressure over several Titrationssequenzen example, away gradually raised to a plausible maximum level (Figure 1a) and are then lowered again over several Titrationssequenzen of time to the initial pressure level (Figure 1c). It is also possible that
Print management concepts to combine according to figures 1a, 1b, 1c and 1d.
In the titration, the measurement signals detected in this preferably are evaluated with regard to any contained therein indicative of a disturbed breathing. The type of respiratory disorder and, optionally, the degree thereof may be preferably stored as an evaluation feature in association with the herein set breathing gas pressure in a characteristic diagram. The data stored in this map entries can be analyzed simultaneously or in a subsequent evaluation procedure summarized. Due to the overall evaluations carried out, it is possible to set indicative indices and any necessary therapy pressure in terms of an optionally existing disease.
The titration algorithm is preferably characterized by the following features:
The course of the titration is carried out according to a standardized pressure guide concept.
The detection of breathing disorders is performed by use of standardized evaluation criteria, making it reproducible. - Detection of disordered breathing may be selectively set according to various medical standards.
Detection of disordered breathing is preferably carried out from the signals of the flow, pressure, oxygen saturation, body position, EOG and EEG. - A possibly required by the patient effective therapy pressure is from the
won analysis of the recorded measurement signals.
The titration algorithm is preferably embedded in a calibration mode and a therapeutic or validation mode. The examination procedure is preferably designed so that the titration mode preferably extends over the first half of a study night and the supply of respiratory gas is carried out in the remaining time of the sleeping patients already under the determined under the conditions titration therapy.
_ The change from the titration in the therapy or validation mode can take place under program control taking into account several switching criteria. The program sequence can be determined manually, semi-automatically and fully automatically.
In the context of the titration, a check of the effective therapy pressure can be effected by lowering defined for a specific interval and / or a certain number of breaths of the pressure. The pressure reduction can be carried out by a step function or phase, under return to a reference pressure level.
Figure 3 shows an arrangement for examining a patient 30 with sleep-disordered breathing. The patient 30 wearing a nasal breathing mask applied 31 About this Atmemaske 31 it is possible to supply the patient 30 ambient air at a pressure level that is at least temporarily to the ambient pressure. The AtemgasΣufuhr via a flexible respiratory gas tube 32 which is coupled via a pneumotachograph 33 with the patient's own CPAP device 34th
The CPAP device is connected to a humidifier 35 and an internal
Pressure regulating means provided. The internal pressure regulating means includes a pressure measurement sensor which is acted upon by a pressure measuring tube 36 in a conventional manner. The pressure control means may be configured so that they present at the pressure measuring tube pressure than the actual pressure and interpreted in response to a set pressure, the
regulates Drehzeahl a fan of the CPAP device.
In the arrangement shown, pressure measuring tube 36 is connected to a printing module 37 by means of which defined an auxiliary pressure source 38 pressures at the pressure measuring tube 36 are applied. By the printing module 33 it is further also possible for the pressure measurement tube 36 can be switched with a leading to the breathing mask pressure measurement tube portion 36a - to couple. The use of the printing module 36 and the auxiliary pressure source makes it possible for the fan speed of the CPAP device 34 without interfering with the internal device
Control to control and adjust the pressure on the respective desired Titrationsequenzdruckniveau. it is also possible alternatively, to connect with existing interface of the CPAP device of this via a data line 39 with the Titrationssteuereinheit 40th As far as the CPAP device has a sufficiently precise gas flow measuring device and gas pressure measuring device, the respective measuring signals can be obtained 37 and 38 immediately above the CPAP device, dispensing with the components 33.
About the Titrationssteuereinheit 40 execution and measurement data collection, according to the above-described
Stress management concepts are initiated.
The data collected can be continuously evaluated by program implemented evaluation procedures. The preferably continuously determined and, if necessary continuously improved evaluation results, and, in particular suspected suitable operation settings for the CPAP device can be visualized if necessary in connection with particularly relevant breathing patterns on a display device 41st Via an input device 42, for example in the form of a keyboard and / or mouse, it is possible to take on the course of Signaltitration and the measured value acquisition influence.
After the end of titration, the arrangement shown can be operated under settings that have been determined in the course of the titration. The quality of the respiratory gas pressure setting can be described by particular characteristics and visualized.
Further details, in particular for the classification and automatic assessment of breathing in each Titrationssequenzen result from the following description. The breath 1 shown in Fig. 4 with respect to the time course of the respiratory gas flow comprising an inspiration phase and an expiration phase I E. The determination of respiratory phase boundary G between the inspiratory phase and the expiratory phase by superimposed evaluation of several
Kurvendiskussion criteria, particularly taking into consideration the currently prevailing breathing pattern and the extreme values of the respiratory gas flow and the pattern of the tidal volume determined and taking into account the respiratory phase periods of previous breaths. The course of the respiratory gas flow 4a shown in Fig. Describes the
Respiratory gas flow curve for an undisturbed breath. The breath assessment may be the temporal conditions, such as the inspiration and Exspirationzeit another or done to other properties such as the total breath length. According to a particularly preferred embodiment of the invention, the ratio of the inspiration time and the
Total breath length is calculated to changes in breathing can be seen.
In Fig. 4b of the course of the respiratory gas flow is shown over a longer time window of time. As can be seen from this illustration, the individual breaths vary in particular with regard to the occurring here
Minima / maxima. The registered in this illustration Horizonfallinie 2 illustrates the statistically for inspiration phases with the highest probability occurring maximum respiratory gas flow. In addition may be carried out a statistical analysis of Inspiration- expiratory breath and total time over a plurality of breaths (preferably 10 breaths).
In Fig. 4c, the temporal course of an indicative of the respiratory gas pressure signal is shown, this signal comprises Oszillationssequezen 3a, 3b, 3c, 3d and 3e which are caused by snoring. The pressure oscillations caused by snoring can have a near-patient
Pressure detecting means for example, a respiratory gas pressure measuring tube can be detected. It is also possible to detect such pressure variations across the microphone means, or on the basis of the power reference of a respiratory gas conveying device. In Fig. 4d of the temporal course of the respiratory gas flow for multiple, is represented by a cessation of breathing period 5 broken breaths. 1 The detected on the basis of the respiratory gas flow apnea period 5 has a, a predetermined limit value of for example 10 seconds border period of time and is thus classified as an apnea phase. Both the breaths detected in this diagram prior to the apnea period 5 and the subsequent breaths show Flusslimitationsmerkmale which are recorded in association with each breath.
Fig. 5 shows the time course of the respiratory gas flow with an included therein Hypopnoephase 6. The Hypopnoephase 6 is then considered to be present if after three classified as normal breaths 1 followed by at least two but not more than three breaths whose difference volume compared to the preceding three breaths a predetermined limit exceeds.
Fig. 6 shows time course for the respiratory gas flow for a plurality of breaths, said visible here, the first 4 breaths 1 show Flusslimitationsmerkmale. This Flusslimitationsmerkmale are shown in the course of the respiratory gas flow by local plateaus formed therein, and 7 by a plurality of
Maxima 8 recognizable. In the illustrated breaths the Flusslimitationsmerkmale occur in each case on the inspiratory phase of each breath. 1 To the illustrated here, the first 4 breaths 1, three still partly flow-limited breaths 1 h close to a Hypopnoephase attributable and partly also show still Flusslimitationsmerkmale.
Fig. 7 shows the course of the respiratory gas flow at a classified as stable respiratory period. The flow of breathing gas, the breathing frequency, the amplitude and the breathing pattern of the respiratory gas flow are within a predetermined range which can be defined as the time domain or by a number of breaths, a regular basis. Respiratory stability moves in the illustrated case the course of the respiratory gas flow above a respiratory stability limit of 0.86. In addition may be carried out a statistical analysis of the inspiration time / expiratory time, and the total breath time over several breaths (preferably 10 breaths). While the illustrated stage of stable breathing no breathing disorders occur (OSA).
In FIG. 8, the waveform of the respiratory gas flow is shown for a plurality of breaths, wherein during the illustrated period of time the respiratory flow is irregular and for individual breaths disordered breathing (OSA) occur. In addition may be carried out a statistical analysis of the inspiration time / expiratory time, and the total breath time over several breaths (preferably 10 breaths). In the embodiment shown here, the respiratory stability index is below the limit of preferably alive 0.911.
In Fig. 9, the time course of the respiratory gas flow is shown in conjunction with a respiratory gas pressure signal. In the respiratory gas pressure signal phased high-frequency Oszilllationen are included in the present example, the inspiratory snoring can be assigned.
In Fig. 10 the time course of the respiratory gas flow is shown for several breaths, the respiration phases is irregular and, for example present from the time T1 by mask leaks or by mouth caused disorder. From the time T1 exceeding a predetermined limit value is carried out which can be considered an indication of a system failure by mouth breathing mask or through leaks.
The generation of an invention is indicative of the physiological state of a patient evaluation result can be applied for controlling the respiratory gas pressure in a positive pressure ventilation. One such application is described below in conjunction with FIGS. 11 to 21. The supply of respiratory gas to the patient is performed using a nasal respiratory mask applied which is connected via a breathing gas hose to a source of breathing gas is provided through which breathing gas to a variable adjustable pressure level. This breathing gas supply assembly comprises a pressure detecting means for generating an indicative of the respiratory gas pressure signal and a breathing gas flow detecting means for detecting a indicative of the respiratory gas flow signal. The indicative of the respiratory gas flow signal is produced by an evaluation device analyzes the generated by reference to a predetermined evaluation systems, evaluation characteristics. This evaluation features are considered linked and result in the fulfillment of specified criteria linked to changes in the respiratory gas pressure or information to classify the patients.
In the illustrated in Fig. 11 the course of the indicative of the respiratory gas flow signal after the tenth shown here breath a first classified as an apnea respiratory disorder phase to the duration occurs is approximately 15 seconds. Following this apnea phase, a series of breaths which have partly Flusslimitationsmerkmale follows. Following this part flow-limited breaths a second classified as an apnea phase phase impaired respiration which extends over a period of 15 seconds also follows. After this second apnea phase is followed by a number (here six) of
Breaths, which have in part flusslimitationsindikative characteristics. At this breath sequence, a phase disordered breathing includes the classified here as a third apnea phase. Following this third apnea phase three breaths carried whose tidal volume will exceed an adaptively adapted limit and thus associated with a Hypopnoephase. By the specified occurrence of said three apnea the time interval of the apnea each other and with respect to which subsequent to the third apnea phase Hypopnoephase a linkage criterion is met, and thus an evaluation result generates the previously set breathing gas pressure than at low rates, and an increase in pressure to a
causes pressure level of 2 mbar. The breaths occurring at a pressure of 11 mbar by increasing the respiratory gas pressure are further analyzed for features contained therein and away linked over a larger time window considered.
In Fig.12, the temporal course of the respiratory gas flow is shown, wherein the evaluation of the detected respiratory flow signals detects a flow-limited breath and in successive predetermined time intervals leads to an increase of the breathing gas pressure to a to be classified as normal respiration occurs. The course of the indicative of the respiratory gas flow signal shown in Figure 13 leads to a first breath sequence is classified as a sequence of stable respiration, wherein the persistent state for a predetermined period of stable breathing causes a lowering of the respiratory gas pressure. Which in this decreased respiratory gas pressure generated conclusions on a flow-limited breathing part of the respiratory gas pressure indicative signals can.
In view of the apparent in breaths Flusslimitationsmerkmale the respiratory gas pressure is increased again. However, the new respiratory gas pressure level is at least temporarily below the pressure level in the above-stable breathing has been detected.
The course of the indicative of the respiratory gas flow signal shown in Fig. 14 shows a plurality of apnea in part with itself adjoining hypopnea. The temporal position of the apnea and the hypopnea one another leads to an evaluation result, the rank of the prevailing respiratory gas pressure be insufficient and causes an increase in the respiratory gas pressure.
The course of the indicative of the respiratory gas flow signal shown in FIG. 15 reveals three classifiable as hypopnea breath sequences consequences. The temporal position of the hypopnea sequences to one another leads to a Auswertungsresulat the prevailing
Respiratory gas pressure classifies as inadequate and causes an increase in the respiratory gas pressure. Following the increase in the respiratory gas pressure, the course of indicative of the respiratory gas flow signal reveals that is regarded as normal breathing.
Fig. 16 shows a sequence of the indicative of the respiratory gas flow signal showing for the individual breaths Flusslimitationsmerkmale, wherein simultaneously with the occurrence of Flusslimitationsmerkmalen in the breaths occur in the respiratory gas pressure signal oscillations that can be classified as inspiratory snoring.
The Flusslimitationsmerkmale occurring in the individual breaths, in conjunction with the recognized in the respiratory gas pressure signal oscillations to a
Evaluation result describing the prevailing respiratory gas pressure as inadequate and thus causes an increase in the respiratory gas pressure.
The breaths recognized by increasing the respiratory gas pressure are classified as breathing normal breathing.
Once the state of normal respiration over a predetermined period of time lasts can be lowered by for example 2 mbar as shown in Fig. 17 the respiratory gas pressure. This reduced respiratory gas pressure level is maintained as long as even at this no Flusslimitationsmerkmale in the individual
Breaths are recognizable. Also takes place at this pressure level over a predetermined period of time to be classified as a normal breathing the breathing gas pressure can be further lowered.
After this phase, normal respiration of the respiratory gas pressure as shown in Fig. 18 may be represented further be lowered. Occur in this further lowered breathing gas pressure in the individual sensed breaths Flusslimitationsmerkmale, so can be increased again on the basis of a linked consideration of the determined for the individual breaths breath features of the breathing gas pressure.
In Fig. 18 is still the course of the respect of the respiratory gas flow and of the indicative of the respiratory gas flow signal, in the case of z. B. System disorder caused by mask leak illustrated. The case detected pressure drop of the breathing gas and the simultaneously occurring hereby rise
Respiratory gas flow, run the rated current system state as faulty in the generation of an evaluation result. The inventive system is adjusted such that in case of a classified as a mask leakage fault, the delivery rate of the respiratory gas source is adjusted such that the fault until the occurrence of the prevailing respiratory gas pressure is largely maintained.
As is apparent from the illustration of Fig. 19, an occurred, for example, by temporarily moving a breathing mask classified as a mask leakage system disorder can be, for example lifted after change of the patient's head position and breathing to be continued under the retained even during system failure respiratory gas pressure. On the basis of indicative of the respiratory gas flow signal can be also detected as shown in FIG. 20 can be seen, whether mouth breathing is present.
In Fig.21, the temporal course of an indicative of the respiratory gas flow signal S is illustrated. This signal is recorded, for example, as so-called. Raw data signal by a computer connected to a dynamic pressure measuring point pressure sensor with a sampling frequency of Σ.B 10 to 500 Hz. The
Raw data signal S may have a Approximationssystem 20 using, for example, implemented in Approximationsprozeduren series expansions in the form of a Fast Fourier analysis, one (eg) MP3 compression, Laplace series expansion binomial series expansion, correlation series expansion, etc. are recorded in compressed form.
The optionally compressed raw data of the signal S can be recorded within a data sequence D.
In the data sequence D can continue by reference to several
Evaluation systems 21 evaluation characteristics M are generated, for example, describe the specific properties of breaths or time periods.
On the basis of the possibly compressed raw data of the signal S and / or the evaluation characteristics M one evaluation result is generated by evaluating characteristics of a linking M consideration are subjected under a result generation step at least. In the case of the use of the inventive system for adjusting a pressure of a respiratory gas of the evaluation results can be a signal that specifies, for example, the instantaneous respiratory gas pressure as appropriate, as too low or too high. As a further result of the analysis is a necessary requisite amount of change in respiratory gas pressure can be determined. Also control parameters for adjusting and synchronizing the respiratory gas pressure at a bi-level pressure control can be determined as the evaluation results.
The linking consideration of evaluation characteristics M is preferably carried out with the involvement of Boolean operations, the Boolean variables Ai,
A 2, Bι ... E ... 2 of individual evaluation features M and / or summary evaluation of Auswerungsmerkmale M, for example,
Evaluation feature groups ai, a 2, bi, c 2, are generated. The
Evaluation results can be the result of a variety OR-linked operation systems.
Based on the evaluation results raw data sets or evaluation feature sets may be selected to generate the desired statements, such as pressure change amount, and typing indices (FLI, snoring index, ...) can be used.
The Approximationssystem 20, the evaluation system 21 and systems for linking consideration of evaluation characteristics M and the preparatory generating Boolean variables are preferably provided by a configured by means of a program data set computing device.
The evaluation results can be generated as part of a data-Postprozessings, or in real time - or sufficiently timely manner - are used in the adjustment of a respiratory gas pressure or configuration of a printing control system.
The evaluation results can be provided to a pressure control algorithm is available which is preferably configured such that it provides for a breathing gas pressure control at least two Druckregelungsmodi which differ in their response behavior. So it is possible to operate a respiratory gas pressure control system in a basic mode in which certain events or a sum of events causes an increase in the respiratory gas pressure.
As part of a sensitive mode, it is possible to perform the pressure control such that it responds to detected events, where appropriate, with a lower delay. This sensitive mode can be particularly set when the respiratory gas pressure such as stable after a period
Breathing (AS> 0.91 1) was lowered.
According to the basic mode is preferably provided, then to cause an increase in pressure, when two large and three small apneas occur and the breathing gas pressure is less than 14 mbar, or a cessation of breathing is detected exceeding a predetermined time period of eg 2 minutes. In this case, a pressure increase by two mbar can be initiated.
In the basic mode, a pressure increase of 1 mbar can then preferably be made when three Hypopnoesequenzen in a predetermined
Timing sequence can be detected. Pressure increases to a pressure level of 1 mbar are preferably then made, if> 0.911 at A flow limitations of B or C may occur at a respiratory stability index of D breaths.
The basic mode is also preferably adjusted so that a pressure reduction is caused by that, if a stable respiratory a respiratory stability index AS> 0.911 exist over a time period of at least 9 minutes. In this case, a reduction in pressure to preferably 2 mbar is caused. In the context of the base mode, a pressure change is particularly suppressed when the respiratory stability index is <0.911 and this detected Limitationserscheinungen in the individual breaths not exceed a predetermined severity criterion. As part of the Sensitive mode an increase in the respiratory gas pressure to, for example, 2 mbar is then caused when two large or three small apneas are present and the breathing gas pressure <14 mbar. In case of three Hypopnoesequenzen an increase in the respiratory gas pressure to 1 mbar.
Upon the occurrence of Flusslimitationsmerkmalen in the examined breaths an increase in the respiratory gas pressure to 1 mbar is then initiated when four of B have Flusslimitationsmerkmale breaths and breathing stability index is> 0.87. A pressure increase of 1 mbar is also initiated if C D breaths have Flusslimitationsmerkmale and respiratory stability index <0.911. Show D B of breaths Flusslimitationsmerkmale and is the respiratory stability index is below a value of 0.911 is carried out in the sensitive mode, also an increase in the respiratory gas pressure to 1 mbar.
A lowering of the respiratory gas pressure occurs in sensitive mode already exist where a stable breathing over a period of 3 minutes exists and respiration stability index> 0.911. In this case, the breathing gas pressure can be lowered by for example 2 mbar
Similarly as in the mentioned basic mode no pressure change is caused when breathing is classified as unstable and in the individual breaths <0.911 breathing disorder features are recognizable in a respiration stability index in the Sensitiv- mode.
Both in the normal mode and in the sensitive mode, it is preferably provided that events such as swallowing, coughing, mouth breathing, particularly expiratory mouth breathing, arousals and speaking, at least not cause any respiratory gas pressure variation when the respiratory gas pressure is below a threshold of, for example, 14 mbar.
The linking consideration can, for example, lead to changes in pressure. It can also lead to the calculation of patient-typical indexes by are selected by this that the relevant measurement data that are relevant for the respective index and were determined in a patient stage that ensures a high informational value.
Priority Applications (5)
|Application Number||Priority Date||Filing Date||Title|
|DE10311704A DE10311704A1 (en)||2003-03-17||2003-03-17||Titration of physiological measuring signals in conjunction with the observation of a patient suffering from sleep-related respiratory problems, during which observation the titration pressure is varied|
|DE2003126817 DE10326817A1 (en)||2003-06-13||2003-06-13||Titration of physiological measuring signals in conjunction with the observation of a patient suffering from sleep-related respiratory problems, during which observation the titration pressure is varied|
|PCT/EP2004/002781 WO2004082751A1 (en)||2003-03-17||2004-03-17||Method and arrangement for the titration of physiological measuring signals in conjunction with the observation of a patient in terms of sleep-related respiratory problems|
|Publication Number||Publication Date|
|EP1605998A1 true EP1605998A1 (en)||2005-12-21|
Family Applications (1)
|Application Number||Title||Priority Date||Filing Date|
|EP04721162A Withdrawn EP1605998A1 (en)||2003-03-17||2004-03-17||Method and arrangement for the titration of physiological measuring signals in conjunction with the observation of a patient in terms of sleep-related respiratory problems|
Country Status (4)
|US (1)||US20060249149A1 (en)|
|EP (1)||EP1605998A1 (en)|
|JP (1)||JP2006520227A (en)|
|WO (1)||WO2004082751A1 (en)|
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Effective date: 20051017
Inventor name: VON STAUFFENBERG, CASPAR, GRAF
Inventor name: MEIER, JOERG
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Inventor name: MADAUS, STEFAN
Inventor name: SCHAETZL, STEFAN
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