Trial Outcomes & Findings for Diagnosing Intensive Care Unit (ICU) Acquired Weakness (NCT NCT04166630)
NCT ID: NCT04166630
Last Updated: 2022-08-19
Results Overview
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Day 1
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
ICU Acquired Weakness Group
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
17
|
|
Overall Study
COMPLETED
|
5
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
ICU Acquired Weakness Group
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Diagnosing Intensive Care Unit (ICU) Acquired Weakness
Baseline characteristics by cohort
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=17 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
49.5 years
STANDARD_DEVIATION 21.3 • n=99 Participants
|
44.6 years
STANDARD_DEVIATION 21.4 • n=107 Participants
|
45.5 years
STANDARD_DEVIATION 21.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
17 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 2 subjects data sets in the No ICU Acquired Weakness Group, were lost due to device malfunction. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=13 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Peak Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 20 Hz
|
0.476 units of Gravity
Standard Deviation 0.467
|
1.639 units of Gravity
Standard Deviation 0.772
|
|
Peak Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 40 Hz
|
0.541 units of Gravity
Standard Deviation 0.591
|
1.608 units of Gravity
Standard Deviation 0.803
|
|
Peak Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 60Hz
|
0.373 units of Gravity
Standard Deviation 0.402
|
1.300 units of Gravity
Standard Deviation 0.662
|
PRIMARY outcome
Timeframe: Day 1Population: 1 subject data set in the No ICU Acquired Weakness Group, could not be analyzed due to excessive subject motion during the trial. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.
The highest acceleration over a single muscle twitch will be used as the peak acceleration. Peak acceleration will be measured in acceleration in number of times gravity (g). Higher twitch acceleration is a better response.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=14 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Peak Acceleration Measured in Tibialis Anterior
Twitch acceleration at 20 Hz
|
0.105 Units of Gravity
Standard Deviation 0.151
|
1.115 Units of Gravity
Standard Deviation 0.677
|
|
Peak Acceleration Measured in Tibialis Anterior
Twitch acceleration at 40 Hz
|
0.102 Units of Gravity
Standard Deviation 0.144
|
1.029 Units of Gravity
Standard Deviation 0.585
|
|
Peak Acceleration Measured in Tibialis Anterior
Twitch acceleration at 60 Hz
|
0.101 Units of Gravity
Standard Deviation 0.153
|
0.593 Units of Gravity
Standard Deviation 0.494
|
PRIMARY outcome
Timeframe: Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 HzThe time, in seconds, until peak acceleration is reached will be assessed at 2, 4 and 6 Hz. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=13 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
Day 1 at 2 Hz
|
64.7 Seconds
Standard Deviation 69.3
|
119.5 Seconds
Standard Deviation 55.1
|
|
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
Day 1 at 4 Hz
|
9.8 Seconds
Standard Deviation 14.1
|
64.6 Seconds
Standard Deviation 56.2
|
|
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
Day 1 at 6 Hz
|
1.5 Seconds
Standard Deviation 1.8
|
33.7 Seconds
Standard Deviation 53.2
|
PRIMARY outcome
Timeframe: Day 1The time, in seconds, until peak acceleration is reached will be assessed. There is not a reference range for the time to peak force and at this time it is unclear if a shorter or longer time to peak force indicates a more desirable state of health.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=14 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Time to Peak Acceleration Measured in Tibialis Anterior
Day 1 at 2 Hz
|
45.5 Seconds
Standard Deviation 68.6
|
100.1 Seconds
Standard Deviation 53.0
|
|
Time to Peak Acceleration Measured in Tibialis Anterior
Day 1 at 4 Hz
|
22.0 Seconds
Standard Deviation 47.9
|
32.3 Seconds
Standard Deviation 43.3
|
|
Time to Peak Acceleration Measured in Tibialis Anterior
Day 1 at 6 Hz
|
8.8 Seconds
Standard Deviation 19.6
|
19.3 Seconds
Standard Deviation 27.1
|
PRIMARY outcome
Timeframe: Day 1Population: 2 subjects data sets in the No ICU Acquired Weakness Group, were lost due to device malfunction. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=13 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
End Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 20 Hz
|
0.289 Units of Gravity
Standard Deviation 0.328
|
1.383 Units of Gravity
Standard Deviation 0.524
|
|
End Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 40 Hz
|
0.147 Units of Gravity
Standard Deviation 0.161
|
1.021 Units of Gravity
Standard Deviation 0.755
|
|
End Acceleration Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 60 Hz
|
0.239 Units of Gravity
Standard Deviation 0.263
|
1.133 Units of Gravity
Standard Deviation 0.521
|
PRIMARY outcome
Timeframe: Day 1Population: 1 subject data set on the No ICU Acquired Weakness Group, could not be analyzed due to excessive subject motion during the trial. One additional subject had no data due to a malfunction with the accelerometer firmware The device manufacturer was contacted and were able to update the device, but no data was recorded during that trial.
End acceleration is the twitch acceleration averaged over 5 twitches over the last second of stable twitches within the stimulation period. A reference range has not yet been established for this measurement.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=5 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=14 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
End Acceleration Measured in Tibialis Anterior
Twitch acceleration at 20 Hz
|
0.057 Units of Gravity
Standard Deviation 0.081
|
1.088 Units of Gravity
Standard Deviation 0.703
|
|
End Acceleration Measured in Tibialis Anterior
Twitch acceleration at 40 Hz
|
0.042 Units of Gravity
Standard Deviation 0.067
|
0.767 Units of Gravity
Standard Deviation 0.517
|
|
End Acceleration Measured in Tibialis Anterior
Twitch acceleration at 60 Hz
|
0.059 Units of Gravity
Standard Deviation 0.083
|
0.640 Units of Gravity
Standard Deviation 0.565
|
PRIMARY outcome
Timeframe: Day 1Population: The team was unable to calculate change for 2 subjects in the ICU Acquired Weakness group. These had palpable contractions, but not large enough to displace the skin above the muscle. 1 subject's results were accidentally deleted and the device manufacturer deemed them unrecoverable. Another subject had no data due to software malfunction, the device manufacturer was able to update the device, but no data was recorded during that trial.
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement. A higher ratio indicates less change from maximum. A lower score would indicate worse outcome.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=3 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=13 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 20 Hz
|
0.578 ratio
Standard Deviation 0.266
|
0.862 ratio
Standard Deviation 0.284
|
|
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 40 Hz
|
0.306 ratio
Standard Deviation 0.194
|
0.562 ratio
Standard Deviation 0.349
|
|
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Twitch acceleration at 60 Hz
|
0.639 ratio
Standard Deviation 0.136
|
0.707 ratio
Standard Deviation 0.223
|
PRIMARY outcome
Timeframe: Day 1Population: The team was unable to calculate change for 3 subjects in the ICU Acquired Weakness group. These had palpable contractions, but not large enough to displace the skin above the muscle. 1 subject's results were accidentally deleted and the device manufacturer deemed them unrecoverable. Another subject had no data due to software malfunction, the device manufacturer was able to update the device, but no data was recorded during that trial.
Fatigue ratio is the ending acceleration divided by peak acceleration during a given stimulation period. A reference range has not yet been established for this measurement.
Outcome measures
| Measure |
ICU Acquired Weakness Group
n=2 Participants
Participants with a score less than 48 on the Medical Research Council (MRC) Scale will be classified as having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
No ICU Acquired Weakness Group
n=14 Participants
Participants with a score of 48 or greater on the Medical Research Council (MRC) Scale will be classified as not having ICU acquired weakness. All participants will have their skeletal muscles tested with a clinical electrical stimulator.
Clinical Electrical Stimulator: Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
|
|---|---|---|
|
Fatigue Ratio Measured in Tibialis Anterior
Twitch acceleration at 2 Hz
|
0.610 ratio
Standard Deviation 0.364
|
0.899 ratio
Standard Deviation 0.351
|
|
Fatigue Ratio Measured in Tibialis Anterior
Twitch acceleration at 4 Hz
|
0.471 ratio
Standard Deviation 0.414
|
0.572 ratio
Standard Deviation 0.247
|
|
Fatigue Ratio Measured in Tibialis Anterior
Twitch acceleration at 6 Hz
|
0.437 ratio
Standard Deviation 0.414
|
0.549 ratio
Standard Deviation 0.265
|
Adverse Events
ICU Acquired Weakness Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No ICU Acquired Weakness Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place