Safety and Performance of Muscle Activation for Critical Care Patients

Stopped early · Not applicable

Conditions studied: Critically-ill

In brief

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.

Key facts

Study ID

NCT01552616

Run by

Niveus Medical, Inc.

People needed

5

Starts

2012-02-01

Expected to finish

2013-02-01

Last updated by the study team

2013-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is enrolled within 60 hours of admission to the ICU
• Patient expected to be subject to bedrest in the ICU for > 96 hours

You may not qualify if…

• 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

Where it is running

• University of Arizona Medical Center — Tucson, Arizona, United States
• Franklin Square Medical Center — Baltimore, Maryland, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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