Safety and Performance of Muscle Activation for Critical Care Patients

NCT01552616 | Terminated

• 1 other identifier: NMSA
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Muscle Activation Effectiveness

  Research team will assess whether or not visible or palpable muscle contractions can be activated in the target patient population.

  Day of ICU Discharge, expected on average 5 days

Secondary Outcomes (7)

• Muscle Mass

  At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)

• Muscle Strength

  At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)

• Activities of Daily Living

  At hospital discharge (expected average 10 days)

• Six Minute Walk

  At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)

• Time to ambulation

  During timeframe when patient moves out of bed, expected on average 5 - 8 days into study

Study Arms (2)

Activation Treatment

EXPERIMENTAL

Procedure: Thermal-aided muscle activation

Usual Care

NO INTERVENTION

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

Interventions

Thermal-aided muscle activation 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.

Activation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is enrolled within 60 hours of admission to the ICU
• Patient expected to be subject to bedrest in the ICU for \> 96 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• Niveus Medical, Inc.: lead

Study Sites (5)

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Franklin Square Medical Center

Baltimore, Maryland, 21237, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Tidswell, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 13, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

US (5)