Clinical trial NCT01552616: 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
Overall status: TERMINATED
Phase: NA
Conditions: Critically-ill
Lead sponsor: Niveus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Muscle Activation Effectiveness
timeFrame: Day of ICU Discharge, expected on average 5 days
Secondary outcomes:
measure: Muscle Mass
timeFrame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
measure: Muscle Strength
timeFrame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
measure: Activities of Daily Living
timeFrame: At hospital discharge (expected average 10 days)
measure: Six Minute Walk
timeFrame: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
measure: Time to ambulation
timeFrame: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
measure: Length of stay
timeFrame: At end of study, expected on average after 10 days
measure: Ventilator Dependency
timeFrame: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Baltimore
country: United States
facility: Franklin Square Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Baystate Medical Center
name: Mark Tidswell, MD
role: PRINCIPAL_INVESTIGATOR
References: