WO2011009911A1 - Dispositif de mesure de la respiration et procédé pour son exploitation - Google Patents

Dispositif de mesure de la respiration et procédé pour son exploitation Download PDF

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Publication number
WO2011009911A1
WO2011009911A1 PCT/EP2010/060633 EP2010060633W WO2011009911A1 WO 2011009911 A1 WO2011009911 A1 WO 2011009911A1 EP 2010060633 W EP2010060633 W EP 2010060633W WO 2011009911 A1 WO2011009911 A1 WO 2011009911A1
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WIPO (PCT)
Prior art keywords
gas
concentration
phase
measured values
gas mixture
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PCT/EP2010/060633
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German (de)
English (en)
Inventor
Volker Gross
Ulrich Koehler
Keywan Sohrabi
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Philipps-Universität Marburg
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Publication of WO2011009911A1 publication Critical patent/WO2011009911A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4806—Sleep evaluation
    • A61B5/4818—Sleep apnoea

Definitions

  • the invention relates to a method for controlling a measuring device for detecting physiological values of the respiration of a person. Furthermore, the invention relates to a device for detecting physiological values of the respiration of a person, which device has at least one Gaskonzentrationsdosier-, at least one measuring device and at least one data processing device.
  • COPD Chomboospasmodic Obstructive Pulmonary Disease
  • COPD Chomboospasmodic Obstructive Pulmonary Disease
  • One method for determining the respiratory response is the so-called CO 2 rebreathing method according to Read.
  • the subject breathes in a bag with several liters of gas volume in and out again.
  • the CO 2 content of the rebreathed air increases steadily.
  • the respiratory response is calculated. Based on the measured respiratory response is concluded on the severity of the disease.
  • this method after Read only allows very inaccurate statements (if any). Accordingly, this method is also unsuitable for being able to make precise statements.
  • Another diagnostic method is to allow the patient to exhale as quickly as possible, measuring the air flow rate (air volume per unit time) and its temporal change over a short period of time.
  • air flow rate air volume per unit time
  • the rapid exhalation behavior of the affected patients changes, so that the severity of the disease can also be deduced here.
  • it is particularly problematic in this method that the patients must actively participate. It can always lead to measurement inaccuracies, but also to specific manipulation attempts (for example, to obtain a disability pension).
  • the object of the invention is thus to propose a measuring method which is improved over the prior art or devices suitable for this purpose.
  • a method for controlling a measuring device for detecting physiological values of the respiration of a person such that the measuring device outputs a gas mixture, wherein during at least one main measurement phase, the concentration of at least one first gas of the gas mixture is kept at least temporarily constant and the concentration of at least one second gas of the gas mixture is changed at least temporarily, and wherein a plurality of individual measured values is detected during the main measurement phase, wherein the individual measured values are respectively saved to a single record.
  • transcutaneous sensors could be used which measure a certain (or more) gas concentrations in the subject's blood. It is particularly advantageous if non-invasively measured values are used. Such non-invasively obtained measured values are usually less time-consuming and / or cheaper to obtain and, moreover, less stressful for the patient. As a rule, it is particularly useful if measured values are obtained which are in a relatively close logical relationship with the respiration of the subject. But other measurements can of course be used, such as the pulse rate and / or the blood pressure of the subject.
  • the term "individual measured value” is generally to be understood as representing a patient-related measured value . These individual measured values are each obtained and stored as a single data record, so that the temporal development of the respective measured value (s) at a later time This can also increase the significance of the results obtained with the proposed methods, In particular, it is also possible to use a particularly large number of measuring points (for example 20, 30, 40, 50, 60, 70, 80, 90, 100 or Of course, it is also possible to determine the concentration of not just a single gas. change and / or keep constant. Rather, it is also possible that the concentration of several gases changed and / or kept constant.
  • the concentration ratio of these gases is at least temporarily kept the same and / or changed.
  • the concentration changes preferably take place based on the measurement requirements required in the individual case.
  • concentration fluctuations of the nitrogen content, the helium content, etc. of the breathing air are generally irrelevant to breathing (as long as they do not fluctuate extremely). Accordingly, it is possible here to provide no concentration control for these gases, which can reduce the cost of the apparatus on which the method is applied.
  • such non-relevant gases can be used well to "top up” the entire gas mixture to 100%. If the concentration of a gas (or several gases, if appropriate also the concentration ratio of different gases) is kept constant and / or changed, this can be done in a controlled manner in particular. For example, a suitable control using an electronic control can take place here. As a result, the concentration of the respective gas can be controlled particularly accurately, which can further increase the validity of the results obtained with the proposed method.
  • the individual data records for the output of at least one output value are mathematically linked to one another.
  • the individual measurements obtained are generally less "handy” (ie for direct, immediate interpretation by an operator of the device, medical professional). staff and / or a doctor).
  • "more intuitive" output data can be calculated and output, which in particular can simplify the interpretation by the person concerned (for example the operator of the device, medical personnel and / or a doctor).
  • a single value is output, or several (advantageously relatively few) values are output to each allow a particularly fast interpretation and / or a more accurate interpretation.
  • the individual measured values together with at least one measuring parameter each form a single data record.
  • the individual measured values usually relate to physiological data of the test person
  • the measuring parameters usually relate to a device parameter of the measuring device with which the proposed method is carried out. This may be, for example, the respective concentration of one or more gases.
  • other measurement parameters such as external measurement parameters
  • the individual measured values form a single data record together with at least one measuring parameter, the accuracy of the proposed method can be increased even further.
  • the first gas is oxygen and / or the second gas is carbon dioxide.
  • the carbon dioxide concentration is (at least temporarily) changed successively. This applies in particular to the main measurement phase of the proposed method.
  • the demanded gas flow rate per unit of time represents a time-averaged value and is also known as "respiratory minute volume.”
  • the respiratory rate represents the number of breaths of a subject per time unit.
  • the respiratory rate is the maximum of the gas volume flow during inhalation and respiration It is particularly advantageous if the method is carried out in such a way that the concentration of at least one second gas of the gas mixture changes only slowly in relation to the respiratory velocity of the test subject
  • a larger number of measured values / data sets can be recorded, in particular by means of a correspondingly slow change of the relevant concentration an "averaging" over several breaths is possible, so that statistically fluctuations can be compensated.
  • a total measurement duration of, for example, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 minutes has proved to be advantageous for the main measurement phase (with the respective values could be used as the lower value and / or as the upper value of an (possibly open) interval).
  • At least one of the at least one main measurement phases proceeds at least one pre-measurement phase during which the concentration of the first gas and / or the concentration of the second gas is not changed at least temporarily, preferably the total composition of the gas mixture is at least temporarily not changed, and during which preferably a plurality of individual measured values are recorded, wherein the individual measured values are each stored in a single data record, wherein the data records are preferably used for determining the length of the pre-measurement phase and / or preferably enter into the calculation of the at least one output value.
  • respiration between different subjects generally varies to such an extent that the validity of the values obtained by the proposed method is adversely affected and, in extreme cases, may even become completely unusable if no corresponding correction is made , Therefore, it is suggested that the individual respiratory parameters of the subject under standard conditions are first recorded during a pre-measurement phase before the actual main measurement phase begins.
  • an approximately normal breathing air concentration can be used as the standard condition.
  • a slightly increased oxygen concentration can be provided.
  • the individual measurement values obtained in the course of the pre-measurement phase can be used to determine the length of the pre-measurement phase (for example, a pre-measurement phase may be discontinued if the subject's breathing has "leveled off", for example by not exceeding a statistical limit)
  • the measured values obtained in the course of the pre-measurement phase can be included in the calculation of the at least one output value by determining the individual standard values of the output values Determine respiration of the subject and let it flow into the calculation of the at least one output value.
  • At least one of the at least one main measuring phase and / or at least one of the at least one pre-measuring phase precedes at least one preliminary phase during which the concentration of the first gas and / or the concentration of the second gas is at least temporarily not changed, and while the plurality of individual measured values is detected, wherein the individual measured values are each stored in a single record, and wherein the data sets preferably for determining the length of the preliminary phase and / or for determining the length the Vormessphase be used, but preferably not enter into the calculation of at least one output value.
  • the test person can first get used to the measuring situation and calm down.
  • the reassurance of the subject is relatively fast, typically within 1, 2, 3, 4 or 5 minutes. It is possible to determine the duration of the preliminary phase by a certain period of time. However, it is also possible to determine the duration of the preliminary phase by individual measured values obtained during the preliminary phase.
  • the preliminary phase can be ended if the subject's breathing has leveled off to a certain value, ie the subject has "calmed down."
  • Excitement of the test person is usually atypical for the breathing behavior of the test person, and therefore would generally distort the informative value of the test, it is particularly advantageous if the test results obtained during the preliminary phase Measured values are not included in the calculation of the at least one output value.
  • the rate of change in the individual readings ie, for example, the change in respiratory minute volume as a function of the change in carbon dioxide concentration
  • many respiratory disorders such as COPD
  • the tests carried out so far have shown that the respiratory response very often leads to a "kink" in the respiratory response curve (respiratory minute volume plotted against the carbon dioxide concentration), ie the slope of the corresponding curve (the rate of change of the individual measured value) changes abruptly.
  • the main measurement phase is terminated by a termination condition, which is preferably taken from the group of termination conditions, which a defined period of time, a Exceeding a gas concentration, exceeding a critical gas concentration and exceeding at least one physiological value comprises. If a specific period of time is specified as the maximum period of time, this can prove to be particularly advantageous because students can be ordered in a specific, defined time frame. In this case, the method is particularly suitable for screening procedures. Exceeding a certain gas concentration (for example of carbon dioxide) can be used particularly advantageously as a termination criterion if a gas concentration changes, for example due to the respiration of the subject himself.
  • a termination condition which is preferably taken from the group of termination conditions, which a defined period of time, a Exceeding a gas concentration, exceeding a critical gas concentration and exceeding at least one physiological value comprises.
  • termination criteria such as exceeding a critical gas concentration and / or exceeding at least one critical physiological value (for example, pulse rate, respiratory rate, respiratory minute volume, etc.) are provided.
  • a particularly high level of security can be realized.
  • two or more termination criteria which need not necessarily come from the group mentioned) with each other.
  • At least one of the at least one main measurement phase is followed by at least one decay phase during which the gas mixture is preferably adjusted to an approximate ambient condition.
  • This can increase the comfort for the subject.
  • the subject it is also possible for the subject to be supplied, for example, with an increased oxygen concentration over a certain period of time in order, for example, to compensate for the physiological reactions to, for example, increased carbon dioxide concentration.
  • At least one of the at least one output values indicates a severity level for at least one lung disease and / or for at least respiratory disease.
  • the output value may be, for example, immediate (eg, direct issue of a disease category) and / or indirectly (for example, by issuing multiple values to be interpreted by the operator of the device, by healthcare professionals, and / or by physicians).
  • the proposed method is particularly suitable for the diagnosis of lung diseases and / or respiratory diseases (including the diagnosis of the severity of the disease in question). Particularly noteworthy is the suitability for the diagnosis and evaluation of the severity of hypoventilation or the diagnosis of respiratory response.
  • a device for detecting physiological values of the respiration of a person which at least one Gaskonzentrati- onsdosiervoriques, preferably at least one Gaskonzentrationsdosier- device for each gas, particularly preferably for each variable and / or relevant gas of a gas mixture, at least one measuring device which at least a physiological single reading of the breathing of a person detected, as well as at least one data processing device, wherein the device is designed and arranged such that it can perform the method described above.
  • the device in question then also has the advantage and properties already described in connection with the method in an analogous manner. Moreover, it is possible to further develop the device in the sense of the proposals made in connection with the method.
  • the device has at least one closed gas circulation and / or at least one air circulation means and / or at least one gas addition agent and / or at least one gas removal agent and / or at least one gas flow meter and / or at least one dehumidifying agent and / or at least one volume equalizing agent.
  • a closed gas circulation it is possible in a particularly simple manner, for example, to change the carbon dioxide concentration of the gas mixture offered by a subject.
  • the exhaled by the subject carbon dioxide can be used to change the carbon dioxide concentration. This is usually very easy.
  • At least one air circulating means such as a fan or a fan, is advantageously used.
  • the oxygen concentration can be kept constant by that according to the "consumption" of oxygen by the subject (withdrawal of oxygen by the respiration of the subject) by an appropriate addition (“Nachsch manen") of oxygen.
  • a gas removal means for example a chemical agent which can bind carbon dioxide, for example.
  • a gas flow meter With the aid of a gas flow meter, it is possible, in particular, to determine the respiratory minute volume and / or the short-term gas volume flow of the subject.
  • the at least one volume compensation means can be used, in particular, to control the to compensate for the volume of gas introduced or removed from the measuring device by the respiration of the subject.
  • the (closed) gas volume of the device is at least the same size, preferably larger, particularly preferably significantly larger than the lung volume of a human being.
  • a slow change in concentration of a gas such as carbon dioxide can be easily realized (even using a closed gas cycle).
  • a slow change of at least one gas concentration is generally particularly advantageous with regard to the significance of the output values obtained.
  • Volumes of 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 l, particularly preferably 6-8 l, have proved to be particularly advantageous volumes.
  • the numerical values mentioned can not only be used as discrete individual values, but also as a lower limit or upper limit for an interval with intermediate values. This applies not only to the numerical values available but also to the numerical values already mentioned above.
  • FIG. 1 shows an exemplary embodiment of an apparatus for carrying out a measuring method for detecting physiological values of the respiration of a person
  • FIG. 2 shows an exemplary embodiment of a combined advance phase and pre-measurement phase
  • 3 shows an exemplary illustration of a main measurement phase
  • 4 shows an exemplary illustration of a part of measured values obtained during a main measurement phase
  • FIG. 6 shows an exemplary embodiment of a possible execution scenario for a measurement method.
  • a possible embodiment for a respiratory response measuring system 1 is shown in a schematic view.
  • the respiratory response measuring system 1 is a closed gas circuit 2.
  • the closed gas circuit 2 can be ventilated or vented in a controlled manner via corresponding valves 3 to 7 (the actuation of the valves 3 to 7 can take place, for example, via an electronic control device 34).
  • the closed gas circuit 2 is opened via a mouthpiece 8 to a subject 9 out.
  • the test person 9 breathes in via the mouthpiece 8 the gas mixture present in the closed gas circuit 2 and then back into the closed gas circuit 2.
  • an elastic airbag 1 1 is provided with a corresponding volume, which communicates via a connection opening 12 with the closed gas circuit 2 in connection.
  • the elastic airbag 1 1 is protected in a housing 13.
  • the housing 13 is connected to the environment via a pneumotachograph 14. With the aid of the pneumotachograph 14, the inspired or exhaled gas volume can thus be determined. Indirectly, 14 further values can be measured with the help of the pneumotachograph, such as the respiratory volume (breathed air measured in liters per minute).
  • the functions of the respiratory response measuring system 1, such as the control of the intake valves 3, 5, 6, 7 and the exhaust valve 4 and the shuttle valve 10, and the storage of the different sensors (in particular the pneumotachograph 14, the respiratory gas sensor 21 and the respiratory response -Messsensorik 22) delivered measurements and their subsequent processing is carried out by an electronic control device 34, which is connected via corresponding lines 37 with the corresponding devices 2 to 7, 10, 14, 15, 21, 22.
  • the electronic control device 34 is connected to an operating unit 35, via which data can be input or read out.
  • the gas mixture in the closed gas circuit 2 is as homogeneous as possible, a flow pump 15 is provided which continuously circulates the gas in the closed gas circuit 2.
  • the flow pump 15 has a throughput of 50 liters per minute.
  • the gas mixture in the closed gas circuit 2 is typically sufficiently mixed within less than 3 seconds.
  • the connection opening 12 of the mouthpiece and the connection opening 12 of the elastic airbag 1 1, a pressure wave damper 17 downstream, which makes the air flow for the downstream Lucasgemischarbeitarbeitung.
  • the gas is supplied in flow circuit 16 of a foreign gas inlet 18, via which the gas via an oxygen inlet valve 5 with oxygen and / or via a carbon dioxide inlet valve 6 can be acted upon with carbon dioxide.
  • the oxygen inlet valve 5 it is possible, for example, to realize a constant oxygen content in the closed gas circulation 2 despite the loss of oxygen as a result of the respiration of the subject 9.
  • the carbon dioxide inlet valve 6 for example, a faster increase of the carbon dioxide oxide concentration can be effected, as this is possible by the generation of carbon dioxide as a result of the respiration of the subject 9 alone.
  • the foreign gas inlet 18 simultaneously acts as a distributor for one of the two partial circuits 16a, 16b of the flow circuit 16. Which of the two branches is selected by the gas flowing therethrough depends on the position of the shuttle valve 10.
  • the gas in the closed gas circuit 2 flows through a carbon dioxide absorber 19.
  • the carbon dioxide absorber 19 may be, for example, one with sodium bicarbonate granules act filled container. With the help of the carbon dioxide absorber 19, the closed gas cycle 2 targeted carbon dioxide can be withdrawn. If, however, the shuttle valve 10 is in a position opposite thereto, then the gas flows through the connecting line 16b, bypasses the carbon dioxide absorber 19 and is therefore not treated. Of course, it is also possible that the shuttle valve 10 assumes an intermediate position.
  • a condenser 20 Downstream of the shuttle valve 10 in the flow circuit 16, a condenser 20 is arranged, which extracts moisture from the gas in the closed gas circuit 2. The moisture is inevitably introduced via the respiration of the subject 9 in the closed gas circuit 2. Subsequently, the flow circuit 16 via an inlet valve 3, via which the closed gas circuit 2 can be supplied with ambient air. The position of the intake valve 3 can be controlled by the electronic control device 34. Subsequently, the gas flows through the already described flow pump 15 in the flow circuit 16. Thereafter, the gas flows through an outlet valve 4 (which is controlled for example by the electronic control device 34), via the gas the closed gas circuit 2 can be discharged into the environment. This is necessary in particular when gas is supplied to the closed gas circuit 2 via one of the inlet valves 3, 5, 6, 7.
  • a nitrogen inlet valve 7 is provided behind the outlet valve 4. With the aid of a suitable amount of nitrogen, the gas mixture can be "filled up to 100%.” In this way it is possible to set specific specific oxygen concentrations and / or carbon dioxide concentrations in the closed gas circuit 2.
  • the respiratory response measuring system 1 a respiratory gas sensor 21 and an air drive measurement sensor 22.
  • Atmospheric gauging sensor 22 is a fast shutter in conjunction with a (sub) pressure sensor, and when inhaled, mouthpiece 8 is momentarily closed (for example, 1/10 of a second) by respiratory gauging sensor 22, as a result of inhalation in the mouthpiece Negative pressure a measure of the so-called Atemant rubbed.
  • FIG. 6 shows, in a schematic flow diagram 23, a conceivable execution scenario for carrying out a measuring method.
  • the respiratory response measuring system 1 After the respiratory response measuring system 1 has been switched on in step 24, the respiratory response measuring system 1 initially passes through an initialization step 25.
  • various self-tests are initially carried out (for example, the flow pump 15 is switched on, and the valves 3 to 7, 10 and Pneumotachograph 14 are tested for function).
  • a specific gas mixture in the closed gas circuit 2 is provided. This may in particular be a gas mixture which (approximately) corresponds to the ambient conditions.
  • the data of the subject 9 are determined, entered into the respiratory response measuring system 1 using the operating unit 35, and the test person 9 is connected to the respiratory response measuring system 26. Thereafter, the actual measuring cycle 27 started (indicated by a dashed line in the flowchart).
  • the measuring cycle 27 initially begins with a calming phase 28 during which no measured values are obtained (or in which the measured values obtained from the electronic control device 34 are subsequently not used for calculating the output values of the respiratory response measuring system 1).
  • the subject 9 receives a gas mixture which typically corresponds approximately to that of normal ambient air.
  • the resting measurement 29 begins. Even during the resting measurement 29, the test person 9 receives a gas mixture which is usually approximated to the ambient air. During rest measurement 29, the typical tidal breathing behavior for the test person 9 is determined. This respiratory behavior at rest is different for different subjects 9. By taking into account the data measured in the course of the sleep measurement 29, the output value of the respiratory response measuring system 1 can become more accurate.
  • the course of calming phase 28 and resting breathing 29 is shown in more detail in FIG.
  • the gas mixture supplied to the subject 9 is mixed with about 22% by volume of oxygen and about 0.4% by volume of carbon dioxide (this corresponds approximately to the composition of normal ambient air).
  • the actual main measuring cycle 30 begins.
  • the oxygen content in the closed gas circuit 2 is left at 40% by volume via corresponding oxygen supply via the oxygen inlet valve 5.
  • the carbon dioxide content is slowly and successively increased to a final value of typically 8 percent by volume of carbon dioxide.
  • the increase of the carbon dioxide content can either be done by the respiration of the subject 9 itself or accelerated to accelerate the main measurement cycle 30 by the controlled addition of carbon dioxide via the carbon dioxide inlet valve 6.
  • the decay phase 31 begins, in which the subject again ambient air is supplied.
  • further measured values can be recorded, in particular in order to check the recovery of the subject for the carbon dioxide stimulus during the main measuring cycle 30. If necessary, the values obtained here can be stored and used for the calculation of the output value.
  • FIG. 2 shows typical measurement data which were recorded in a temporal course of a calming phase 28 with a subsequent resting measurement 29 in a subject 9.
  • the abscissa 38 shows the time in minutes, while along the ordinate 39 the respiratory minute volume (AMV) of the subject 9 is plotted in liters per minute. Both during the reassurance phase 28, and during the rest measurement 29, the subject receives 9 room air.
  • the subjects 9 are usually very nervous, which is typically expressed in a quick and shallow breathing. Accordingly, the initial measurements in FIG. 2 show a high respiratory minute volume. After a short time, the subjects 9 calm down, which is also clearly evident from the data shown in FIG. As an advantageous value in practice, a preliminary phase (reassurance phase 28 and rest measurement 29 taken together) with a time length of 5 minutes has been proven. During the relaxation phase 28, the measured values obtained are not taken into account for the subsequent calculation of the output value. On the other hand, the measured values obtained during resting measurement 29 are used as the individual resting sensation values of the respective subject 9. During the main measuring cycle 30, the carbon dioxide content is successively increased, while the oxygen content of the sample 9 fed gas mixture is constantly adjusted to 40 percent by volume oxygen content.
  • the progressive region 42 of FIG. 3 is shown enlarged. As can be clearly seen in FIG. 4, the progressive region 42 can be approximately approximated by a linear regression line.
  • the carbon dioxide limit value 41 is defined as the point at which, for the first time, an excess of the AMV quiescent value by more than twice the standard deviation from the quiescent measurement 29 occurs.
  • the slope of the linear compensator 43 is determined by linear regression.

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Abstract

L'invention porte sur un procédé (23), destiné à commander un dispositif de mesure (1), lequel sert à déterminer les valeurs physiologiques de la respiration d'une personne (9), où le dispositif de mesure (1) émet, pendant différentes phases de mesure (28, 29, 30, 31), différents mélanges gazeux. Pendant une phase de mesure principale (30), on maintient constante, au moins par périodes, la concentration d'au moins un premier gaz du mélange gazeux, et on modifie, au moins par périodes, la concentration d'au moins un deuxième gaz du mélange gazeux. En outre, pendant la phase de mesure principale (30), on détermine un grand nombre de valeurs de mesure individuelles, chacune des valeurs de mesure individuelles étant mémorisée dans un jeu de données individuel.
PCT/EP2010/060633 2009-07-24 2010-07-22 Dispositif de mesure de la respiration et procédé pour son exploitation WO2011009911A1 (fr)

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CN104713989B (zh) * 2015-02-04 2016-08-17 中国科学院合肥物质科学研究院 一种基于混合室技术的气体代谢检测装置及方法

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