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Diagnosing Intensive Care Unit (ICU) Acquired Weakness

Primary Purpose

ICU Acquired Weakness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Electrical Stimulator
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ICU Acquired Weakness focused on measuring Biofeedback, Muscular disorders, Neuromuscular disorders, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ICU Acquired Weakness Group

No ICU Acquired Weakness Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2019
Last Updated
July 25, 2022
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04166630
Brief Title
Diagnosing Intensive Care Unit (ICU) Acquired Weakness
Official Title
Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Acquired Weakness
Keywords
Biofeedback, Muscular disorders, Neuromuscular disorders, Rehabilitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICU Acquired Weakness Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No ICU Acquired Weakness Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Clinical Electrical Stimulator
Other Intervention Name(s)
Vectra Genisys Therapy System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Peak Acceleration Measured in Extensor Carpi Radialis Longus
Description
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 Frame
Day 1
Title
Peak Acceleration Measured in Tibialis Anterior
Description
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 Frame
Day 1
Title
Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
Description
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 Frame
Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz
Title
Time to Peak Acceleration Measured in Tibialis Anterior
Description
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.
Time Frame
Day 1
Title
End Acceleration Measured in Extensor Carpi Radialis Longus
Description
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.
Time Frame
Day 1
Title
End Acceleration Measured in Tibialis Anterior
Description
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.
Time Frame
Day 1
Title
Fatigue Ratio Measured in Extensor Carpi Radialis Longus
Description
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.
Time Frame
Day 1
Title
Fatigue Ratio Measured in Tibialis Anterior
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randi Smith, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the publications will be available for sharing, after deidentification.
IPD Sharing Time Frame
Data will be available for sharing beginning 9 months after article publication and ending 36 months following article publication.
IPD Sharing 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).

Learn more about this trial

Diagnosing Intensive Care Unit (ICU) Acquired Weakness

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