NCT01552616

Safety and Performance of Muscle Activation for Critical Care Patients

Evaluation of Thermal-aided Muscle Activation in Intensive Care Unit (ICU) Patients - A PILOT Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Niveus Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critically-ill

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-03-13
• Last updated: 2013-04-09

Locations

5 sites across 1 country: United States