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Safety and Performance of Muscle Activation for Critical Care Patients

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ClinicalTrials.gov Identifier: NCT01552616
Recruitment Status : Terminated (Enrollment)
First Posted : March 13, 2012
Last Update Posted : April 9, 2013
Sponsor:
Information provided by (Responsible Party):
Niveus Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Critically-ill Procedure: Thermal-aided muscle activation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study
Study Start Date : February 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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.



Primary Outcome Measures :
  1. Muscle Activation Effectiveness [ Time Frame: Day of ICU Discharge, expected on average 5 days ]
    Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.


Secondary Outcome Measures :
  1. Muscle Mass [ Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) ]
    Muscle mass will be measured at several time points during the patient stay.

  2. Muscle Strength [ Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days) ]
    Muscle strength will be assessed using MRC scales at various time points throughout the study

  3. Activities of Daily Living [ Time Frame: At hospital discharge (expected average 10 days) ]
    The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.

  4. Six Minute Walk [ Time Frame: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days) ]
    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.

  5. Time to ambulation [ Time Frame: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study ]
    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.

  6. Length of stay [ Time Frame: At end of study, expected on average after 10 days ]
    The subject's length of stay will be recorded from chart review.

  7. Ventilator Dependency [ Time Frame: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient ]
    Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552616


Locations
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United States, Arizona
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, Maryland
Franklin Square Medical Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Niveus Medical, Inc.
Investigators
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Principal Investigator: Mark Tidswell, MD Baystate Medical Center
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Responsible Party: Niveus Medical, Inc.
ClinicalTrials.gov Identifier: NCT01552616    
Other Study ID Numbers: NMSA
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: April 9, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes