N/A
N=22
Diagnosing Intensive Care Unit (ICU) Acquired Weakness
ICU Acquired Weakness
Bottom Line
View on ClinicalTrials.gov: NCT04166630 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Peak Acceleration Measured in Extensor Carpi Radialis Longus — 0.476; 1.639; 0.541; 1.608 units of Gravity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinical Electrical Stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Acceleration Measured in Extensor Carpi Radialis Longus |
0.476; 1.639; 0.541; 1.608; 0.373; 1.300 | — |
| PRIMARY Peak Acceleration Measured in Tibialis Anterior |
0.105; 1.115; 0.102; 1.029; 0.101; 0.593 | — |
| PRIMARY Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus |
64.7; 119.5; 9.8; 64.6; 1.5; 33.7 | — |
| PRIMARY Time to Peak Acceleration Measured in Tibialis Anterior |
45.5; 100.1; 22.0; 32.3; 8.8; 19.3 | — |
| PRIMARY End Acceleration Measured in Extensor Carpi Radialis Longus |
0.289; 1.383; 0.147; 1.021; 0.239; 1.133 | — |
| PRIMARY End Acceleration Measured in Tibialis Anterior |
0.057; 1.088; 0.042; 0.767; 0.059; 0.640 | — |
| PRIMARY Fatigue Ratio Measured in Extensor Carpi Radialis Longus |
0.578; 0.862; 0.306; 0.562; 0.639; 0.707 | — |
| PRIMARY Fatigue Ratio Measured in Tibialis Anterior |
0.610; 0.899; 0.471; 0.572; 0.437; 0.549 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04166630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.