Safety and Performance of Muscle Activation for Critical Care Patients

NCT ID: NCT01552616

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Activation Treatment

Group Type: EXPERIMENTAL

Thermal-aided muscle activation

Intervention Type: PROCEDURE

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.

Usual Care

This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Niveus Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Tidswell, MD

Role: PRINCIPAL_INVESTIGATOR

Baystate Medical Center

Locations

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

Countries

United States

Other Identifiers

NMSA

Identifier Type: -

Identifier Source: org_study_id