Diagnosing Intensive Care Unit (ICU) Acquired Weakness

Not Applicable

Completed

• Conditions: ICU Acquired Weakness
• Interventions: Device: Clinical Electrical Stimulator

• Registration Number: NCT04166630
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2021-02-02
• Primary Completion: 2021-06-11
• Study Completion: 2021-06-11
• Results First Submitted: 2022-06-03
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Results First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients transferred from the ICU to a lower level of care within the past 7 days
• Mechanical ventilation for greater than 7 days while in the ICU
• Ability to understand English and provide written consent

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Exclusion Criteria

• Vulnerable populations including: patients who are pregnant or prisoners
• Patients who are unable to understand English or provide written consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No ICU Acquired Weakness Group	Clinical Electrical Stimulator	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.
ICU Acquired Weakness Group	Clinical Electrical Stimulator	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.

Primary Outcome Measures

Name	Time	Method
End Acceleration Measured in Tibialis Anterior	Day 1	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.
Fatigue Ratio Measured in Extensor Carpi Radialis Longus	Day 1	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.
End Acceleration Measured in Extensor Carpi Radialis Longus	Day 1	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.
Peak Acceleration Measured in Extensor Carpi Radialis Longus	Day 1	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.
Peak Acceleration Measured in Tibialis Anterior	Day 1	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.
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus	Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz	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.
Time to Peak Acceleration Measured in Tibialis Anterior	Day 1	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.
Fatigue Ratio Measured in Tibialis Anterior	Day 1	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.

Trial Locations

Locations (1)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States