Safety and Performance of Muscle Activation for Critical Care Patients
NCT01552616 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2013-04-09
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
- 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.
Sponsors & Collaborators
-
Niveus Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Mark Tidswell, MD · Baystate Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2013-02-28
- Completion
- 2013-02-28
Countries
- United States
Study Locations
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