Clinical trial NCT04166630: Diagnosing Intensive Care Unit (ICU) Acquired Weakness
Official title: Accelerometer Motion to Measure Muscle Fatigue in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICU Acquired Weakness
Keywords: Biofeedback
Muscular disorders
Neuromuscular disorders
Rehabilitation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Peak Acceleration Measured in Extensor Carpi Radialis Longus
timeFrame: Day 1
measure: Peak Acceleration Measured in Tibialis Anterior
timeFrame: Day 1
measure: Time to Peak Acceleration Measured in Extensor Carpi Radialis Longus
timeFrame: Day 1 at 2 Hz, Day 1 at 4 Hz, Day 1 at 6 Hz
measure: Time to Peak Acceleration Measured in Tibialis Anterior
timeFrame: Day 1
measure: End Acceleration Measured in Extensor Carpi Radialis Longus
timeFrame: Day 1
measure: End Acceleration Measured in Tibialis Anterior
timeFrame: Day 1
measure: Fatigue Ratio Measured in Extensor Carpi Radialis Longus
timeFrame: Day 1
measure: Fatigue Ratio Measured in Tibialis Anterior
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Randi Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: