Back to resultsSafety and Performance of Muscle Activation for Critical Care Patients
Primary Purpose
Critically-ill
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thermal-aided muscle activation
Sponsored by
About this trial
This is an interventional prevention trial for Critically-ill
Eligibility Criteria
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
Sites / Locations
- University of Arizona Medical Center
- Franklin Square Medical Center
- Baystate Medical Center
- University of Massachusetts Medical Center
- Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Activation Treatment
Usual Care
Arm Description
This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments.
Outcomes
Primary Outcome Measures
Muscle Activation Effectiveness
Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
Secondary Outcome Measures
Muscle Mass
Muscle mass will be measured at several time points during the patient stay.
Muscle Strength
Muscle strength will be assessed using MRC scales at various time points throughout the study
Activities of Daily Living
The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.
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.
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.
Length of stay
The subject's length of stay will be recorded from chart review.
Ventilator Dependency
Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01552616
Brief Title
Safety and Performance of Muscle Activation for Critical Care Patients
Official Title
Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
Enrollment
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niveus Medical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically-ill
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activation Treatment
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments.
Intervention Type
Procedure
Intervention Name(s)
Thermal-aided muscle activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle Activation Effectiveness
Description
Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.
Time Frame
Day of ICU Discharge, expected on average 5 days
Secondary Outcome Measure Information:
Title
Muscle Mass
Description
Muscle mass will be measured at several time points during the patient stay.
Time Frame
At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Title
Muscle Strength
Description
Muscle strength will be assessed using MRC scales at various time points throughout the study
Time Frame
At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Title
Activities of Daily Living
Description
The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.
Time Frame
At hospital discharge (expected average 10 days)
Title
Six Minute Walk
Description
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.
Time Frame
At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
Title
Time to ambulation
Description
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.
Time Frame
During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
Title
Length of stay
Description
The subject's length of stay will be recorded from chart review.
Time Frame
At end of study, expected on average after 10 days
Title
Ventilator Dependency
Description
Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject
Time Frame
During active ventilation and weaning period, expected to last on average 4 - 7 days per patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Tidswell, MD
Organizational Affiliation
Baystate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Franklin Square Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
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Safety and Performance of Muscle Activation for Critical Care Patients
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