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The goal of this study is to develop a non-invasive test to diagnose intensive care unit (ICU) acquired weakness that can be administered to both responsive and non-responsive patients. Study participation will involve the measurement of muscle fatigue during a single 30 minute session. Skeletal muscle will be stimulated with an FDA approved clinical electrical stimulator and accelerations will be passively recorded with an accelerometer.
The primary purpose of this study is to develop a procedure to identify intensive care unit (ICU) acquired weakness. This condition occurs in a subset of people admitted into the ICU, and is associated with a 30% increased risk of death before discharge from the ICU. There are currently major limitations in the ability to diagnose ICU acquired weakness, making it difficult to study. The goal is to develop a non-invasive test that can be administered to both responsive and non-responsive patients. The current proposal will focus on replicating the results of previous research using motion detecting accelerometers to measure fatigue in human skeletal muscles. This study is designed to test out the procedures in patients who have been transferred from the ICU to a lower level of care so that follow-on studies can be designed to help mitigate this condition in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU Acquired Weakness Group | Experimental | 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. |
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| No ICU Acquired Weakness Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Electrical Stimulator | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Acceleration Measured in Extensor Carpi Radialis Longus | 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. | Day 1 |
| Peak Acceleration Measured in Tibialis Anterior | 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. | Day 1 |
| Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus | The 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. | Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz |
| Time to Peak Acceleration Measured in Tibialis Anterior | The 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. | Day 1 |
| End Acceleration Measured in Extensor Carpi Radialis Longus | 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. | Day 1 |
| End Acceleration Measured in Tibialis Anterior |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randi Smith, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30322 | United States |
Individual participant data that underlie the results reported in the publications will be available for sharing, after deidentification.
Data will be available for sharing beginning 9 months after article publication and ending 36 months following article publication.
Data will be available for sharing with investigators whose proposed used of the data has been approved for meta-analysis. Information regarding submitting proposals and accessing data will be available by contacting the study staff (contact information to be provided).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Acceleration Measured in Extensor Carpi Radialis Longus | 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. | 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. | Posted | Mean | Standard Deviation | units of Gravity | Day 1 |
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Day 1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randi Smith | Emory University | 404-251-8914 | randi.smith@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2019 | May 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D009422 | Nervous System Diseases |
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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. |
| Day 1 |
| Fatigue Ratio Measured in Extensor Carpi Radialis Longus | 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. | Day 1 |
| Fatigue Ratio Measured in Tibialis Anterior | 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. | Day 1 |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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). |
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| Primary | Peak Acceleration Measured in Tibialis Anterior | 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. | 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. | Posted | Mean | Standard Deviation | Units of Gravity | Day 1 |
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| Primary | Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus | The 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. | Posted | Mean | Standard Deviation | Seconds | Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz |
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| Primary | Time to Peak Acceleration Measured in Tibialis Anterior | The 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. | Posted | Mean | Standard Deviation | Seconds | Day 1 |
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| Primary | End Acceleration Measured in Extensor Carpi Radialis Longus | 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. | 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. | Posted | Mean | Standard Deviation | Units of Gravity | Day 1 |
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| Primary | End Acceleration Measured in Tibialis Anterior | 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. | 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. | Posted | Mean | Standard Deviation | Units of Gravity | Day 1 |
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| Primary | Fatigue Ratio Measured in Extensor Carpi Radialis Longus | 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. | 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. | Posted | Mean | Standard Deviation | ratio | Day 1 |
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| Primary | Fatigue Ratio Measured in Tibialis Anterior | 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. | 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. | Posted | Mean | Standard Deviation | ratio | Day 1 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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). | 0 | 17 | 0 | 17 | 0 | 17 |
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| Twitch acceleration at 60 Hz |
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| Day 1 at 6 Hz |
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| Day 1 at 6 Hz |
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| Twitch acceleration at 60 Hz |
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| Twitch acceleration at 60 Hz |
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| Twitch acceleration at 60 Hz |
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| Twitch acceleration at 6 Hz |
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