Safety and Performance of Muscle Activation for Critical Care Patients

Study Overview
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Brief Summary
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Critically-ill patients who have long stays in the hospital often face prolonged periods of bed rest. It is known that these patient develop profound weakness and debilitation. The effectiveness of existing muscle activation devices that could otherwise prevent the onset of debilitation in an immobilized patient has not been demonstrated widely in this cohort. It is hypothesized that using thermal methods to augment existing muscle activation techniques may demonstrate improved performance with no corresponding change in the safety profile.

Official Title
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Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study

Conditions
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Critically-ill

Intervention / Treatment
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* Procedure: Thermal-aided muscle activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is enrolled within 60 hours of admission to the ICU Patient expected to be subject to bedrest in the ICU for > 96 hours Exclusion Criteria: Patient is age < 18 years at time of consent Patient is pregnant Patient is moribund Patient has an implanted pacemaker/defibrillator Patient has a documented diagnosis of epilepsy Patient has implanted femoral rods Patient has leg or pelvic trauma that limits mobility Patient has recent trauma resulting in GCS < 5 Patient lacks ability to walk without assistance prior to acute ICU admission Patient has neuromuscular disease or abnormalities Patient is morbidly obese (BMI > 40) Patient has a cognitive impairment or inability to follow commands prior to acute ICU admission Patient was transferred after > 48 hours at another acute care institution Enrollment in another investigational device or drug trial that could compromise the conduct or results of the study Evidence of disease or condition that, in the opinion of the physician, may compromise the conduct of or results of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activation Treatment<br> | Procedure: Thermal-aided muscle activation<br>* Thermal-aided muscle activation therapy will be provided to patients twice daily. Treatment will begin within 24 hours of admission and continue until patients are significantly ambulatory.<br>|
| No Intervention: Usual Care<br>This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Activation Effectiveness | Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population. | Day of ICU Discharge, expected on average 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Mass | Muscle mass will be measured at several time points during the patient stay. | At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) | 
| Muscle Strength | Muscle strength will be assessed using MRC scales at various time points throughout the study | At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) | 
| Activities of Daily Living | The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge. | At hospital discharge (expected average 10 days) | 
| Six Minute Walk | A 6 minute walk test administered per ATS guidelines will be undertaken by all patients prior to discharge. When possible at least 2 six minute walk tests will be administered. | At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days) | 
| Time to ambulation | The time needed for a patient who had previously been subjected to bed rest to ambulate will be noted through chart review and nursing interviews. | During timeframe when patient moves out of bed, expected on average 5 - 8 days into study | 
| Length of stay | The subject's length of stay will be recorded from chart review. | At end of study, expected on average after 10 days | 
| Ventilator Dependency | Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject | During active ventilation and weaning period, expected to last on average 4 - 7 days per patient |