Safety and Performance of Muscle Activation for Critical Care Patients

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2013
Start Date:	February 2012
End Date:	January 2013
Contact:	Brian Fahey, PhD
Email:	brian@niveusmedical.com
Phone:	6509624576

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.

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

We found this trial at

sites

The Ohio State University, Wexner Medical Center

410 W 10th Ave
Columbus, Ohio 43210

(614) 293-8652