Safety and Performance of Muscle Activation for Critical Care Patients

Niveus Medical

Status

Terminated

Conditions

Critically-ill

Treatments

Procedure: Thermal-aided muscle activation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01552616

NMSA

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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