Diagnosing Intensive Care Unit (ICU) Acquired Weakness

Emory University

Status: Completed

Conditions: ICU Acquired Weakness

Treatments: Device: Clinical Electrical Stimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04166630

IRB00109793

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

ICU Acquired Weakness Group

Experimental group

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.

Treatment:

Device: Clinical Electrical Stimulator

No ICU Acquired Weakness Group

Experimental group

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.

Treatment:

Device: Clinical Electrical Stimulator