WO1998014115A1 - Abnormal dyspnea perception detection system - Google Patents
Abnormal dyspnea perception detection system Download PDFInfo
- Publication number
- WO1998014115A1 WO1998014115A1 PCT/US1996/015643 US9615643W WO9814115A1 WO 1998014115 A1 WO1998014115 A1 WO 1998014115A1 US 9615643 W US9615643 W US 9615643W WO 9814115 A1 WO9814115 A1 WO 9814115A1
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- Prior art keywords
- patient
- inspiratory
- respiratory
- dyspnea
- inspiration
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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
- A61B5/087—Measuring breath flow
Definitions
- This invention relates to improved methods and apparatus to detect patients with an abnormally altered perception of dyspnea.
- asthma patients At risk for fatal asthmatic attacks.
- An unexpected rising incidence of fatal asthmatic attacks in recent years has been of concern to the medical profession.
- the sensitivity of the testing procedure is enhanced by the test being performed under controlled conditions by having the patient breathe in a precisely defined manner by visual biofeedback means, with the subject following a predetermined breathing pattern on a computer CRT or similar means.
- Hillsman incorporates by reference his U.S. Patent No. 3,991,304 which describes a sophisticated method to prompt patients to desired breathing patterns by visual biofeedback means.
- Pulmonary Disease Emphysema and Chronic Bronchitis
- Pulmonary Rehabilitation including various measures to improve dyspnea distress. These measures include various medications, breathing exercises and breathing retraining in proper breathing patterns, respiratory muscle reconditioning and strengthening by various means, and general body reconditioning and strengthening.
- Present methodology to quantify dyspnea and measure improvement with the various treatment modalities has generally been controversial and unsatisfactory. Therefore, there is a need to properly define and quantify the dyspnea abnormality and any normalization with the various treatments in the patient therapeutic program, both to guide therapy and to document improvement for administrative needs.
- the instant invention to comprehensively define the testing conditions relative to the patient's vital capacity and/or maximum inspiratory pressure capability, and to further define the testing conditions by having the patient breathe in a precisely controlled manner using predefined breathing patterns by visual biofeedback means, and to precisely control the sequence and timing of the testing events. Therefore, by establishing the breathing testing conditions the sensitivity, accuracy and reproducibility of the diagnostic methodology will be enhanced. In addition, by placing definable plus and minus error limits above and below the desired breathing analogs, with suitable audio and or visual alarms to indicate if the patient breathing performance is outside acceptable limits, the diagnostician may determine whether or not the subject is performing in an acceptable manner to the testing methodology as defined by the operator for the particular subject and thereby generating reliable testing data.
- a variable resistive load can be imposed by either a so-called non-linear adjustable "pinhole” orifice restrictive device or a so-called inspiratory "threshold” loading device, the non-linear resistive device being preferred in the present embodiment.
- Chronic Obstructive Pulmonary Disease such as Emphysema and/or Chronic Bronchitis, and/or other respiratory conditions.
- a computer based controlling system that displays the desired patient breathing patterns and real time patient performance for patient biofeedback breathing control, and the patient indication of Borg defined units of dyspnea level.
- Inspiratory pressure is sensed, input to the computer and automatically adjusted to predetermined levels. Data integrity is assured by automated detection of the patient's breathing pattern exceeding plus or minus tidal volume percentage error limits, with appropriate indicating alarms.
- the patient follows the prescribed breathing pattern and tidal volume based on a percentage of the patient's vital capacity at a constant inspiratory pressure predetermined as a percentage of the patient's maximal inspiratory pressure.
- the resultant data is plotted on a graph with the Borg Unit dyspnea level plotted on the vertical "y" ordinate axis versus Time on the horizontal "x" abscissa axis. Also numerically indicated at one minute intervals are the number of times the patient's breathing performance failed to remain within acceptable plus and minus defined parameter error limits.
- the patient follows the prescribed breathing pattern and tidal volume based on a percentage of the patient's vital capacity at progressively increasing inspiratory resistive loads, starting a zero load and then automatically increasing by suitable increments, e.g. minus 5 cm. water pressure at suitable time intervals, e.g. every two minutes.
- suitable increments e.g. minus 5 cm. water pressure
- suitable time intervals e.g. every two minutes.
- the resultant data is plotted on a graph with the Borg Unit dyspnea level on the vertical "y" ordinate axis versus Time on the Horizontal "x" abscissa axis, and in addition the inspiratory pressures are plotted on the vertical "y" axis.
- Also numerically indicated at one minute intervals are the number of times the patient's breathing performance failed to remain within acceptable plus and minus defined parameter error limits.
- Fig. 1 is a simple schematic diagram of the overall system
- Fig. 2 is a schematic diagram of the system and patient interactive devices
- Fig. 3 is a schematic diagram of the Inspiratory Resistive Device, where Fig. 3a is a side view of the Airway Resistor/Stepping Motor Assembly, and
- Fig. 3b is a top view of the Airway Resistive Device
- Fig. 3 c is a side view of the Airway Resistor/Stepping Motor Assembly
- Fig. 4 is a schematic diagram of the breathing Visual Biofeedback Display, where
- Fig. 4a is a display of the patient prompting program breathing analogs
- Fig. 4b is a display of proper patient breathing performance matching the prompting analog display
- Fig. 4c is a display of inadequate patient breathing performance, not achieving the cursor prompted analog display
- Fig. 4d is a display of plus and minus Phantom Line error limits, and the detection of inadequate patient performance
- Fig. 4e is a display of the prompting breathing analog and the patient real time breathing performance, with changing symbols and/or color depending on which error limit the patient's breathing is operative, and
- Fig. 4f is display of an exhausted patient unable to maintain performance requirements and therefore termination of the test
- Fig. 5 is a display of the patient data, where Fig. 5 a is a display of Constant Inspiratory Resistance plotting the Borg Dyspnea
- Fig. 5b is a display of Incremental Inspiratory Resistance plotting the Borg Dyspnea Scale and Inspiratory Pressure against time. DESCRIPTION OF PREFERRED EMBODIMENTS
- metric units and standard respiratory terminology as defined by the American College of Chest Physicians are employed unless otherwise stated. Particular attention is directed toward the testing of human subjects for susceptibility to fatal asthmatic attacks by detecting a decreased awareness of dyspnea distress during the imposition of an inspiratory resistance load. This has been found to be a valid method to test asthmatic patients in this regard, but the known methods have employed relatively simple methodology that fails to standardize the testing conditions adequately.
- the method and apparatus may alternatively be used to test subjects for excessive dyspnea awareness as may be present in the abnormal perception-related condition of Hyperventilation Syndrome, or to define and quantify the dyspnea of patients with Chronic Obstructive Pulmonary Disease and/or other respiratory conditions.
- the underlying object of this invention is to define testing conditions for all appropriate pulmonary function testing procedures in a more precise manner by visual biofeedback means, where the subject is encouraged to follow precisely defined inspiration and expiration visual analogs and thereby make the sensitivity, accuracy and reproducibility of the tested parameter optimally standardized.
- This is based on the general observation that the sophistication of modern pulmonary function testing equipment is usually more accurate than the methodology and the physiologic parameter being tested, due to the natural variability of native patient breathing patterns, and the alteration of these breathing patterns under testing conditions. Therefore, to improve the accuracy of the relevant pulmonary function test, the variable patient breathing patterns must be standardized and quality controlled in order the measuring equipment and the measuring methodology produce more valid data on the tested patient functional parameter.
- the underlying concept of the instant invention relates to precise breathing control using defined visual inspiration and expiration analogs for the subject to follow, with the subject's respiratory Tidal Volume defined as a predetermined percentage of their Vital Capacity, and the Inspiratory Resistance load a predetermined percentage of the subject's Maximum Inspiratory Pressure; or alternatively the Inspiratory Resistance being predetermined time incremental steps of predetermined resistance loads, and to automate the procedure.
- the patient sees a visual analog of inspiration and expiration on a computer CRT or TV display, and with a simultaneous display also visualizes their real time breathing performance analog, with the Tidal Volume breath indicated on the vertical "y" ordinate axis plotted against Time on the horizontal "x" abscissa axis.
- the patient is instructed to match their real time breathing performance to the desired performance analog as indicated by flashing cursor means in the appropriate time domain using so-called visual biofeedback means; thereby conforming the patient's breathing to a defined standard breathing pattern.
- the Tidal Volume breath is determined as a defined standard percentage, generally between 25% and 50% of an independently measured Vital Capacity breath.
- the Inspiratory Resistive negative pressure load is determined as a defined standard percentage, generally between 25% and 75% of an independently measured Maximum Inspiratory Pressure.
- the Respiratory Rate is defined generally between 5 and 15 breaths per minute.
- the Inspiration to Expiration Time Ratio is defined generally between 1 : 1 and 1 :3.
- the Inspiratory Pause Time is defined as a percentage of the Inspiratory Time generally between zero and 10%, and the Expiratory Pause Time is defined as a percentage of the Expiratory Time generally between zero and 25%.
- the Inspiration and Expiration waveforms are defined as linear or various curvilinear forms.
- multiple plus and minus analog error limits as a percentage of the Tidal Volume may be defined and optionally displayed, to detect patient performance falling outside defined limits, with suitable auditory and/or visual alarms to indicate deficient performance.
- the error limit analogs may be hidden from display, with the displayed patient breathing signal changing shape and/or color depending on which error limit the patient's breathing performance is operative.
- the Inspiratory Resistive Load remains constant, with the patient attempting to maintain the desired breathing pattern until unable to maintain said standardized breathing pattern due to fatigue or excessive respiratory distress. At one minute intervals the patient is prompted to indicate their perceived dyspnea level in standard Borg numeric units on a scale of zero to ten (0 to 10), zero indicative of no perceived dyspnea and ten being indicative of maximal perceived dyspnea, by sliding a pointer along a linear potentiometer or similar device for data input. In an alternate mode of operation the Inspiratory Resistive Load is progressively incremented in predetermined negative pressure loads expressed as cm.
- Inspiratory pressures, the integrated respiratory flowTidal Volume, and Borg Dyspnea Units are stored in computer memory, and are reported in graphic form, the Borg Dyspnea Units and Inspiratory Pressure plotted on the vertical "y" axis coordinate against Time on the horizontal "x" axis coordinate.
- the Tidal Volumes may be similarly displayed on the vertical "y" axis coordinate.
- the patient's level of dyspnea may be plotted against a standardized breathing pattern and inspiratory load stress, the normal subject indicating progressive dyspnea, and those subjects susceptible to asthmatic hazard and potential fatality indicating a minimal dyspnea response to progressive inspiratory muscle resistive stress, and with Hyperventilation Syndrome patients and those subjects with Chronic Obstructive Pulmonary Diseases and/or other pulmonary pathological conditions indicating excessive dyspnea at inappropriately low inspiratory work loads.
- the testing process is automated in the appropriate time domain, by feedback computer control of inspiratory pressure adjusting a variable inspiratory resistance device by means of a computer feedback controlled stepping motor. Inspiration Pressures, Tidal Volume, Borg Unit data and the minute by minute frequency of patient failure to achieve acceptable breathing performance is stored in computer memory for display and analysis. In an alternate mode of operation the operator may manually adjust the inspiratory pressure with reference to a separate mechanical pressure gauge.
- This invention is general as to means and method to control breathing during breathing testing, and specific as to means and method to control breathing in a standardized manner while testing for dyspnea awareness with increasing inspiratory resistance loading and stress of inspiratory muscles, to thereby reveal patients with inappropriate and reduced breathing awareness that might subject them to asthma hazard and potential fatality, though the inventive concept would not be limited to specific testing for dyspnea awareness with inspiratory loading.
- This invention could also be used specifically to test patients for excessive dyspnea awareness as may be present in the condition of Hyperventilation Syndrome and a variety of pulmonary pathologic conditions, including Chronic Obstructive Pulmonary Diseases and/or pulmonary Restrictive Diseases.
- the Patient ( 1 ) inspires air through Inspiratory Resistance Device (2) via Directional Respiratory Valve (3). Inspiratory and expiratory air is sensed by Flowmeter (4) and Mechanical Pressure Meter (5).
- the Patient (1 ) observes CRT (6) to visualize Prescribed Breathing Pattern (7) and by visual biofeedback means following Prompting Cursor (8) attempts to place their real time Breathing Signal (9) on the Prescribed Breathing Patten (7).
- the patient is prompted to indicate their perceived level of dyspnea on an electro-mechanical Linear Potentiometer (10) calibrated in zero to ten Borg Dyspnea Units.
- Computer ( 14) provides Inspiratory Resistance Feedback Control Signal (18) to Inspiratory Resistive Device (2).
- the schematic diagram in Fig. 2 is a more detailed overall description of the system design and the patient interactive devices.
- Patient ( 1 ) breaths through Flowmeter (4) which provides a differential pressure due to Flowmeter Restrictions (19).
- the flow generated differential pressure is sensed on each side of Flowmeter Restrictions (19) and detected by Differential Pressure Transducer (20) with subsequent signal conditioning and analog to digital conversion by suitable hardware and/or software means for input of Tidal Volume Signal ( 1 1) to Computer (14).
- the differential pressure detection, signal conditioning and analog to digital conversion may be within Computer ( 14) or by external devices.
- Respiratory pressure is sensed by Mechanical Pressure Meter (5) and Pressure Transducer (21)with subsequent signal conditioning and analog to digital conversion by suitable hardware and/or software means for input of Respiratory Pressure Signal ( 12) to Computer ( 14).
- the pressure detection, signal conditioning and analog to digital conversion may be within Computer (14) or by external devices.
- Computer ( 14) all inspiratory and expiratory pressures at suitable sampling rates, for example 100 Hz., are stored breath by breath in suitable computer memory array means, and pattern recognition algorithms detect and similarly store Peak Inspiratory Pressure and Average Inspiratory Pressure.
- Patient ( 1 ) in response to perceived dyspnea level manipulates sliding scale Pointer (22) on Linear Potentiometer ( 10) to provide Borg Units Signal (13) to Computer ( 14).
- Respiratory flow is directed by Directional Respiratory Valve (3) by Inspiration Valve (23) and Expiration Valve (24) which vents the patient's unobstructed exhaled breath to room air.
- Respiratory Pressure Signal (12) is compared to a predetermined desired inspiratory pressure and Computer ( 14) generates an appropriate Inspiratory Resistance Feedback Control Signal ( 18) to Stepping Motor (28) and Reduction Gear (29) to turn Respiratory Resistance Plate (25) to achieve the desired inspiratory pressure.
- Patient (1) observes CRT (6) to visualize Prescribed Breathing Pattern (7) and by visual biofeedback means following Prompting Cursor (8) attempts to place their real time Breathing Signal (9) on the Prescribed Breathing Patten (7).
- the patient is prompted to indicate their perceived level of dyspnea by Pointer (22) on electro-mechanical Linear Potentiometer (10) calibrated in zero to ten Borg Dyspnea Units.
- Pointer (22) on electro-mechanical Linear Potentiometer (10) calibrated in zero to ten Borg Dyspnea Units.
- data display and Graphics Report (15) are generated for direct viewing or hard copy report.
- the Borg Dyspnea Display ( 16) units and Peak Inspiratory Pressure Display (17) units in cm. water, or optionally the Average Inspiratory Pressure, is plotted on the vertical "y" axis ordinate versus Time on the horizontal "x" axis abscissa.
- FIG. 3 is a more detailed overall description of the Inspiratory Resistive Device (2).
- Fig. 3a. is a side view of Inspiratory Resistive Device (2) and Stepping Motor (28) with Reduction Gear (29) meshing with Respiratory Resistance Plate (25).
- Respiratory Resistance Plate (25) rotates about a central mount on Respiratory Resistance Device (2) and has a Handle (26) to assist manual rotation to permit a variable sized orifice to be exposed to Inspiration Chamber (27).
- Fig 3b.) is a top view of Inspiratory Resistive Device (2) and Inspiration Chamber (27) with centrally mounted Respiratory Resistance Plate (25) containing Variable Orifice (30).
- FIG. 3c. is a top view of Inspiratory Resistive Device (2) and Stepping Motor (28) with Reduction Gear (29) meshing with Respiratory Resistance Plate (25), thereby permitting motor adjustment of Variable Orifice (30) to automatically adjust airway resistance by computer controlled feedback means.
- Fig. 4 The schematic diagrams in Fig. 4 describes various visual biofeedback images seen on CRT (6).
- Fig. 4a. shows Prescribed Breathing Pattern (7) displayed where Tidal Volume is depicted on the vertical "y" ordinate axis plotted against Time on the horizontal "x" abscissa axis, indicating Inspiration in an upward direction and Expiration in a downward direction.
- Fig. 4b. indicates proper patient biofeedback breathing performance with the patient Breathing Signal (9) superimposed on Prescribed Breathing Pattern (7) at Prompting Cursor (8).
- Fig. 4c. indicates inadequate patient biofeedback breathing performance with the patient Breathing Signal (9) falling below Prescribed Breathing Pattern (7) and Prompting Cursor (8).
- Fig. 4a. shows Prescribed Breathing Pattern (7) displayed where Tidal Volume is depicted on the vertical "y" ordinate axis plotted against Time on the horizontal "x" abscissa axis, indicating Inspiration
- Fig. 4d. is identical to Fig. 4c.) and in addition shows plus and minus Phantom Line Error Limits (31 ) above and below Prescribed Breathing Pattern (7) with a Negative Error Limit Detection (32) to trigger appropriate audio and/or visual alarms. Not shown are multiple Phantom Line error detection limits, for example error limits of plus and minus 10% of Tidal Volume, plus and minus 20%, plus and minus 30%, etc.
- Fig. 4e.) is a display of patient performance error detection without the display of the Phantom Lines, wherein only Prescribed Breathing Pattern (7) and patient Breathing Signal (9) appear. In this option the patient Breathing Signal (9) changes to different graphic characters and/or colors, depending on which zone of error detection the patient performance is operative.
- Fig.4 f. is a display of patient exhaustion wherein the Patient Breathing Signal (9) is unable to follow Prescribed Breathing Program (7) and is unable to achieve a minimal Tidal Volume as depicted by Negative Error Limit (33) and thus indicating the need to terminate the testing procedure.
- FIG. 5 describes various CRT graphic displays and/or hard copy printed reports of the derived data.
- Fig. 5 a. is the preferred embodiment wherein the testing procedure has been with constant prescribed inspiratory resistance load, as determined by a predetermined percentage of the Maximum Inspiratory Capacity.
- Graphics Report (15) plots Borg Dyspnea Units and Peak Inspiratory Pressure on the vertical "y" ordinate axis, against Time on the horizontal "x" abscissa axis.
- Optionally Average Inspiratory Pressure may be substituted for Peak Inspiratory Pressure.
- Inspiratory Pressure Display (17) in this mode of operation is a generally a straight line throughout most of the testing procedure, reflecting the ability of the patient to inspire the prescribed Tidal Volume breath within the defined parameters of Prescribed Breathing Pattern (7). Near the end of the testing procedure the inspiratory pressure tends to diminish, reflecting patient exhaustion and the inability therefore to inspire the full prescribed Tidal Volume breath, though in some cases the patient may maintain their ability to breathe as prescribed despite fatigue and severe dyspnea. Numeric Parameter Limit Failure (40) is accumulated and indicated at one minute intervals, and as indicated with increased failure of breathing control as the patient becomes exhausted. A Normal Borg Response (37) to progressive fatigue is indicated.
- Fig. 5b. is an alternate testing method wherein the inspiratory resistive load is applied in incremental steps at prescribed times, e.g. two minute intervals, and with prescribed resistive loads at each incremental step, e.g. zero, -2, -5, -10, -15, -20, -25, -30, etc. cm.
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US1996/015643 WO1998014115A1 (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
CA002238530A CA2238530A1 (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
AU73804/96A AU7380496A (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
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PCT/US1996/015643 WO1998014115A1 (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
CA002238530A CA2238530A1 (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
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WO1998014115A1 true WO1998014115A1 (en) | 1998-04-09 |
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PCT/US1996/015643 WO1998014115A1 (en) | 1996-09-30 | 1996-09-30 | Abnormal dyspnea perception detection system |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1397994A1 (en) * | 2002-09-11 | 2004-03-17 | Micro Medical Limited | Apparatus for measuring the strength of a person's respiratory muscles |
WO2005006980A1 (en) * | 2003-07-11 | 2005-01-27 | Micro Medical Ltd | Apparatus for determining respiratory muscle endurance of a person |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3621833A (en) * | 1969-06-26 | 1971-11-23 | Robert Crane | Method and apparatus for automatically determining physiological parameters related to human breathing airway resistance and functional residual capacity |
US3857385A (en) * | 1970-04-03 | 1974-12-31 | Jaeger E | Direct indicating devices for measuring respiratory resistance |
-
1996
- 1996-09-30 CA CA002238530A patent/CA2238530A1/en not_active Abandoned
- 1996-09-30 WO PCT/US1996/015643 patent/WO1998014115A1/en active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3621833A (en) * | 1969-06-26 | 1971-11-23 | Robert Crane | Method and apparatus for automatically determining physiological parameters related to human breathing airway resistance and functional residual capacity |
US3857385A (en) * | 1970-04-03 | 1974-12-31 | Jaeger E | Direct indicating devices for measuring respiratory resistance |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1397994A1 (en) * | 2002-09-11 | 2004-03-17 | Micro Medical Limited | Apparatus for measuring the strength of a person's respiratory muscles |
WO2005006980A1 (en) * | 2003-07-11 | 2005-01-27 | Micro Medical Ltd | Apparatus for determining respiratory muscle endurance of a person |
GB2420077A (en) * | 2003-07-11 | 2006-05-17 | Micro Medical Ltd | Apparatus for determining respiratory muscle endurance of a person |
GB2420077B (en) * | 2003-07-11 | 2007-09-12 | Micro Medical Ltd | Apparatus for determining respiratory muscle endurance of a person |
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CA2238530A1 (en) | 1998-04-09 |
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