Safety and Performance of Muscle Activation for Critical Care Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Critically-ill
• Intervention / Treatment: Procedure: Thermal-aided muscle activation

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Franklin Square Medical Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Activation Treatment	Procedure: Thermal-aided muscle activation; 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.
NO_INTERVENTION: Usual Care; 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?

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

Collaborators and Investigators

• Sponsor: Niveus Medical, Inc.
• Investigators: Principal Investigator: Mark Tidswell, MD, Baystate Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 5, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NMSA