WO1999009885A1 - Passive, non-invasive method to quantify objectively the level and density of a neural blockade - Google Patents
Passive, non-invasive method to quantify objectively the level and density of a neural blockade Download PDFInfo
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- WO1999009885A1 WO1999009885A1 PCT/US1998/017529 US9817529W WO9909885A1 WO 1999009885 A1 WO1999009885 A1 WO 1999009885A1 US 9817529 W US9817529 W US 9817529W WO 9909885 A1 WO9909885 A1 WO 9909885A1
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- Prior art keywords
- recited
- density
- level
- neural blockade
- blockade
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- 230000001537 neural effect Effects 0.000 title claims abstract description 48
- 238000000034 method Methods 0.000 title claims description 38
- 230000004044 response Effects 0.000 claims abstract description 9
- 239000003589 local anesthetic agent Substances 0.000 claims abstract description 7
- 238000002567 electromyography Methods 0.000 claims description 37
- 230000008859 change Effects 0.000 claims description 12
- 238000002565 electrocardiography Methods 0.000 claims description 12
- 238000012544 monitoring process Methods 0.000 claims description 12
- 230000006461 physiological response Effects 0.000 claims description 8
- 210000003205 muscle Anatomy 0.000 claims description 7
- 230000030214 innervation Effects 0.000 claims description 6
- 230000003444 anaesthetic effect Effects 0.000 claims 1
- 238000005259 measurement Methods 0.000 abstract description 5
- 229960005015 local anesthetics Drugs 0.000 abstract description 2
- 238000009529 body temperature measurement Methods 0.000 abstract 1
- 238000009532 heart rate measurement Methods 0.000 abstract 1
- 238000012360 testing method Methods 0.000 description 6
- 230000002596 correlated effect Effects 0.000 description 5
- 230000003247 decreasing effect Effects 0.000 description 5
- 238000005070 sampling Methods 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 3
- 230000007423 decrease Effects 0.000 description 3
- 239000003193 general anesthetic agent Substances 0.000 description 3
- 238000013480 data collection Methods 0.000 description 2
- 238000012377 drug delivery Methods 0.000 description 2
- 230000000977 initiatory effect Effects 0.000 description 2
- 230000010354 integration Effects 0.000 description 2
- 230000033001 locomotion Effects 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 238000010183 spectrum analysis Methods 0.000 description 2
- 230000002269 spontaneous effect Effects 0.000 description 2
- 230000002123 temporal effect Effects 0.000 description 2
- 210000000115 thoracic cavity Anatomy 0.000 description 2
- 208000012266 Needlestick injury Diseases 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 210000003489 abdominal muscle Anatomy 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 239000003570 air Substances 0.000 description 1
- 239000012080 ambient air Substances 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 229940035674 anesthetics Drugs 0.000 description 1
- 208000008784 apnea Diseases 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000003491 array Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000000747 cardiac effect Effects 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 230000036757 core body temperature Effects 0.000 description 1
- 238000013500 data storage Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 210000002445 nipple Anatomy 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 230000008447 perception Effects 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000011473 radical retropubic prostatectomy Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 210000001113 umbilicus Anatomy 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
- A61B5/1104—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb induced by stimuli or drugs
- A61B5/1106—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb induced by stimuli or drugs to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/389—Electromyography [EMG]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/18—Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
- A61B5/024—Measuring pulse rate or heart rate
- A61B5/0245—Measuring pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
- A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
- A61B5/721—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
- A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
- A61B5/7217—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker
Definitions
- the invention relates to the monitoring of the effectiveness of anesthetics in humans or animals and, more specifically, provides a method for passively, non-invasively and objectively quantifying the level and density of a neural blockade.
- a neural blockade e.g., local anesthetic epidural blockade
- the invention solves the above-described problems by monitoring several physiological responses to neural blockade using a set of non-invasive monitors/sensors and related signal processing without active patient participation or response to quantify objectively the blockade's level and density.
- the invention is a method for passively, non-invasively, and objectively quantifying the level and density of a neural blockade in a patient, comprising the steps of: placing a non-invasive sensor for measuring a physiological response to the neural blockade at a site on the patient's body; and monitoring the changes in the physiological response to the neural blockade using the sensor without active participation or response by the patient to quantify the level and density of the neural blockade.
- the physiological responses that can be monitored and the methods for monitoring include muscle innervation using surface electromyography (EMG) ; skin temperature using a temperature sensing means; and heart rate using electrocardiography (EKG) .
- EMG surface electromyography
- EKG electrocardiography
- the level and density of the neural blockade is quantified by, respectively, the placement of the sensor and a change in the signal amplitude of the surface EMG, wherein the density is inversely proportional to the signal amplitude.
- EMG surface electromyography
- EKG electrocardiography
- the method of the invention can be incorporated in an automated system to, for example, control drug delivery to a patient or advise the clinician about patient status including displaying the level and density of the neural blockade from onset to termination.
- the invention could also be used to monitor neural blockade in animals.
- the onset of neural blockade can be objectively monitored by placement of one or more sensors and quantifying a decrease in signal amplitude of a surface EMG; an increase in skin temperature; and changes in heart rate.
- the blockade density determined by these objective means appears to compare favorably with the results of traditional subjective methods.
- the invention provides the anesthesiologist with positive information regarding the level and density of neural blockade in a non-invasive manner without requiring active patient participation or response.
- Fig. 1 shows a set of curves of the rms EMG signal amplitudes taken from seven patients who consented to be subjects in a study of the method of the invention.
- Fig. 3 shows average temperature data for the dermatomal levels for all seven study subjects.
- Fig. 4 shows the average heart rate for all seven study subjects.
- the method of the invention uses non-invasive sensors placed at one or more sites on a patient's body to monitor primary and reference parameters, as follows: Primary
- Ambient Temperature - in-air thermocouple Core Body Temperature - tympanic thermocouple A non-invasive sensor array that includes sensors for EMG, AMG (in the below-described study) , and peripheral temperature (Fig. la) is placed at each monitor site; EKG and reference sensors are applied where and/or as appropriate (Fig. lb) . Splash-proof coverings can be used to protect each monitor site. To discriminate the cephalo-caudal spatial effect of the neural block it is preferable to use multiple monitor sites as shown in Fig. 1.
- thoracic dermatome nipple, T4
- tenth thoracic dermatome umbilicus, T10 levels on the anterior axillary line and the anterior of the thigh, representing the second lumbar dermatome (L2).
- the level and density of the neural blockade is quantified by, respectively, the placement of the sensor array and a change in the signal amplitude of the surface EMG, wherein the density is inversely proportional to the signal amplitude.
- the level and density of the neural blockade is quantified by, respectively, the placement of the sensor array and a change in skin temperature, wherein the density of the neural blockade is directly proportional to skin temperature.
- the level and density of the neural blockade are quantified by a change in heart rate, wherein the density of the neural blockade is inversely proportional to heart rate.
- EMG Spontaneous surface electromyogram
- AMG acoustomyogram
- T temperature
- Reference measurements included tympanic and ambient temperature, and ambient sound.
- time-series data were acquired before epidural dosing and at predefined intervals after dosing.
- a dedicated PC-based system provided system control and data storage.
- epochs were collected immediately prior to the main epidural dose (baseline) and at 2, 5, 10, 15, 20, 25, 30, 45, 60, 75, and 90 minutes after dosing.
- the epochs were designed to have a minimum duration of 20 seconds.
- Temperature data records were time-continuous, starting immediately after the thermocouples were placed and ending approximately 2 minutes after the last EMG/ MG/EKG sampling epoch.
- Table 2 summarizes the data acquisition conditions for the parameters of interest. Table 2 - Data Acquisition Conditions for Monitored Parameters
- EMG and AMG are broadband signals that contain information in the time and frequency domains. What is needed is a single derived value that is descriptive of the instantaneous physiological condition of the patient. Typically, the power in the signal provides such an indication in the time domain. Power is proportional to the square of the amplitude of the signal. And, for a signal that has a non-constant (e.g. , alternating current) component, it is necessary to average over a finite period of the signal in order to generate a meaningful value.
- EMG assessments have traditionally computed the average rectified EMG (AREMG) or the rectified integrated EMG (RIEMG) , given by:
- n is an important factor.
- the value of n is inversely proportional to the upper frequency response characterized by the computation.
- Running rms values are computed.
- Subsequent rms values incrementally delete the earliest data point and add the next latest point of the series.
- the minimum value of the computed rms sequence is selected as representative of the muscle-only condition for any pre-defined sampling epoch.
- the time-series data from the study subjects demonstrated that EMG and AMG signals contained noise artifacts that correlated to the use of the electrocautery, suction, and other electronic systems.
- the slope and intercept of the frequency spectra of the data were used as acceptance criteria to validate that the rms data values were devoid of noise.
- the absolute value of EMG signals can be influenced by conditions such as skin conductance, skin temperature, electrode displacement, and site preparation.
- the EMG data were normalized, which involved applying a gain factor that resulted in an expansion or compression of the histogram of the raw data sets. Based on a common time epoch for all study subjects, EMG data were normalized such that the basis histogram contained 50% of all data values between ⁇ 5 mV. Other epochs were scaled by the same gain factor calculated for the basis.
- AMG signal artifacts were correlated to motions directly induced by the surgeons or indirectly induced by movements near the patient.
- AMG data are compensated, on a sample-by-sample basis, for the presence of acoustically transmitted noise by subtraction of the ambient signal level.
- T DLSI tympanic and ambient temperatures
- EMG signal amplitude decreased at a rate inversely related to the number of dermatomal levels separating the monitor site and the epidural catheter. That is, the signals at the more cephalad dermatomal levels decreased later than the more caudal levels.
- EMG signal level decreased >15 mV, temperature increased >1°C, and EKG decreased >7 beats per minute (bpm) .
- AMG showed primary correlation to external influences; response to the block was not evident in the presence of noise.
- FIG. 3 presents average temperature data for the dermatomal levels for all seven subjects. All levels exhibit the same upward trend as a function of time; they approach a relative increase of approximately 3.5°C over the 90-minute data collection period. The changes in temperature reflect the effect of sympathectomy upon administration of local anesthetic. These changes also suggest differences in the contribution of blood volume changes and vascular relaxation at each dermatomal level. The average heart rate for all seven subjects is shown in
- a universal neural blockade monitor must be fully functional regardless of when it is applied, relative to the administration of the anesthetic agent.
- the rate of change, or gradient, of the absolute signals presents salient information.
- the most compelling indicator is the change in EMG signal level between the time of zero minutes and 10 minutes, as shown in Figure 2.
- Level L2 decreases approximately 1.5 times that of T10 and 2.5 times that of T4.
- the weighted summation of EMG and temperature will likely satisfy the basic requirement for a level-discriminating determination of block density.
- the method of the invention can be integrated into an automated system for controlling drug delivery to the patient or simply notifying the physician or nurse about patient status, e.g., during post-op recovery.
- the invention is also applicable to use with animal patients.
- the onset of neural blockade can be objectively monitored by placement of one or more sensors and quantifying a decrease in signal amplitude of a surface EMG; an increase in skin temperature; and changes in heart rate.
- the blockade density determined by these objective means appears to compare favorably with the traditional subjective method of pinch-tests.
- the invention provides the anesthesiologist with a passive, objective tool for real-time, non-invasive monitoring of the level and density of neural blockade.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Physics & Mathematics (AREA)
- Public Health (AREA)
- Pathology (AREA)
- Anesthesiology (AREA)
- Neurology (AREA)
- Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Physiology (AREA)
- Dentistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Measuring And Recording Apparatus For Diagnosis (AREA)
- Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
- Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2000507282A JP2001513386A (en) | 1997-08-26 | 1998-08-25 | Passive and non-invasive method for objectively quantifying the level and density of nerve block |
AU91181/98A AU731669B2 (en) | 1997-08-26 | 1998-08-25 | Passive, non-invasive method to quantify objectively the level and density of a neural blockade |
CA002298828A CA2298828C (en) | 1997-08-26 | 1998-08-25 | Passive, non-invasive method to quantify objectively the level and density of a neural blockade |
EP98943362A EP1009279A4 (en) | 1997-08-26 | 1998-08-25 | PASSIVE AND NON-INTRACTIVE PROCESS FOR OBJECTIVELY QUANTIFYING THE LEVEL AND DENSITY OF A NEURONAL LOCK |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/918,446 | 1997-08-26 | ||
US08/918,446 US6002960A (en) | 1996-08-27 | 1997-08-26 | Passive, non-invasive method to quantify objectively the level and density of a neural blockade |
Publications (1)
Publication Number | Publication Date |
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WO1999009885A1 true WO1999009885A1 (en) | 1999-03-04 |
Family
ID=25440400
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/017529 WO1999009885A1 (en) | 1997-08-26 | 1998-08-25 | Passive, non-invasive method to quantify objectively the level and density of a neural blockade |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP1009279A4 (en) |
JP (1) | JP2001513386A (en) |
AU (1) | AU731669B2 (en) |
CA (1) | CA2298828C (en) |
WO (1) | WO1999009885A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113729644A (en) * | 2021-09-06 | 2021-12-03 | 中山大学 | Method for detecting regional nerve block anesthesia effect by using temperature sensing array |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP5221086B2 (en) * | 2007-09-07 | 2013-06-26 | フクダ電子株式会社 | Biological information monitor and biological information monitor control program |
DE102009003897A1 (en) * | 2009-01-03 | 2010-07-15 | Andreas Dr. Penno | Apparatus and method for monitoring the success of spinal anesthesia |
KR101232492B1 (en) * | 2011-02-10 | 2013-02-12 | 성균관대학교산학협력단 | Anaesthsia depth and facial nerve monitoring apparatus using emg signal and method thereof |
KR101658680B1 (en) * | 2011-02-23 | 2016-09-21 | 사회복지법인 삼성생명공익재단 | Apparatus and method for monitoring facial nerve |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5131401A (en) * | 1990-09-10 | 1992-07-21 | Axon Medical Inc. | Method and apparatus for monitoring neuromuscular blockage |
US5195531A (en) * | 1991-03-01 | 1993-03-23 | Bennett Henry L | Anesthesia adequacy monitor and method |
US5320109A (en) * | 1991-10-25 | 1994-06-14 | Aspect Medical Systems, Inc. | Cerebral biopotential analysis system and method |
US5772591A (en) * | 1995-06-06 | 1998-06-30 | Patient Comfort, Inc. | Electrode assembly for signaling a monitor |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4570640A (en) * | 1981-08-06 | 1986-02-18 | Barsa John E | Sensory monitoring apparatus and method |
-
1998
- 1998-08-25 EP EP98943362A patent/EP1009279A4/en not_active Withdrawn
- 1998-08-25 JP JP2000507282A patent/JP2001513386A/en active Pending
- 1998-08-25 CA CA002298828A patent/CA2298828C/en not_active Expired - Fee Related
- 1998-08-25 WO PCT/US1998/017529 patent/WO1999009885A1/en not_active Application Discontinuation
- 1998-08-25 AU AU91181/98A patent/AU731669B2/en not_active Ceased
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5131401A (en) * | 1990-09-10 | 1992-07-21 | Axon Medical Inc. | Method and apparatus for monitoring neuromuscular blockage |
US5195531A (en) * | 1991-03-01 | 1993-03-23 | Bennett Henry L | Anesthesia adequacy monitor and method |
US5320109A (en) * | 1991-10-25 | 1994-06-14 | Aspect Medical Systems, Inc. | Cerebral biopotential analysis system and method |
US5772591A (en) * | 1995-06-06 | 1998-06-30 | Patient Comfort, Inc. | Electrode assembly for signaling a monitor |
Non-Patent Citations (1)
Title |
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See also references of EP1009279A4 * |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN113729644A (en) * | 2021-09-06 | 2021-12-03 | 中山大学 | Method for detecting regional nerve block anesthesia effect by using temperature sensing array |
Also Published As
Publication number | Publication date |
---|---|
EP1009279A1 (en) | 2000-06-21 |
AU9118198A (en) | 1999-03-16 |
AU731669B2 (en) | 2001-04-05 |
EP1009279A4 (en) | 2004-05-12 |
CA2298828C (en) | 2003-11-18 |
JP2001513386A (en) | 2001-09-04 |
CA2298828A1 (en) | 1999-03-04 |
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