Diagnosing Intensive Care Unit (ICU) Acquired Weakness

NCT04166630 | Completed Results FDA Device

• 1 other identifier: IRB00109793
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU Acquired Weakness

Keywords

Biofeedback; Muscular disorders; Neuromuscular disorders; Rehabilitation

Outcome Measures

Primary Outcomes (8)

• 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

  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

Study Arms (2)

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.

Device: Clinical Electrical Stimulator

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.

Device: Clinical Electrical Stimulator

Interventions

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).

Also known as: Vectra Genisys Therapy System

ICU Acquired Weakness Group; No ICU Acquired Weakness Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Muscular Diseases; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Nervous System Diseases

Results Point of Contact

• Title: Randi Smith
• Organization: Emory University

randi.smith@emory.edu

404-251-8914

Study Officials

• Randi Smith, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: February 2, 2021
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: August 19, 2022
• Results First Posted: August 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 9 months after article publication and ending 36 months following article publication.
• Access Criteria: 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).

Locations

US (1)