Diagnosing Intensive Care Unit (ICU) Acquired Weakness

ICU Acquired Weakness Clinical Trial

Official title:

Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166630
• Other study ID #: IRB00109793
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: June 11, 2021

Study information

• Verified date: July 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 11, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Vulnerable populations including: patients who are pregnant or prisoners

• Patients who are unable to understand English or provide written consent

Related Conditions & MeSH terms

• Asthenia
• ICU Acquired Weakness

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1
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.	Day 1
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.	Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1
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.	Day 1