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Clinical Trials/NCT04166630
NCT04166630
Completed
Not Applicable

Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients

Emory University1 site in 1 country22 target enrollmentFebruary 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICU Acquired Weakness
Sponsor
Emory University
Enrollment
22
Locations
1
Primary Endpoint
End Acceleration Measured in Tibialis Anterior
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2, 2021
End Date
June 11, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Randi Smith

Assistant Professor

Emory University

Eligibility Criteria

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

Outcomes

Primary Outcomes

End Acceleration Measured in Tibialis Anterior

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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