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Completed

NCT Number: NCT04166630

Diagnosing Intensive Care Unit (ICU) Acquired Weakness

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.

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Key information

Conditions

ICU Acquired Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Vectra Genisys Therapy System

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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