Safety and Performance of Muscle Activation for Critical Care Patients

Niveus Medical, Inc.5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Critically-ill

Interventions

Thermal-aided muscle activationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Muscle Activation Effectiveness

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

Time frame: Day of ICU Discharge, expected on average 5 days

Secondary Outcomes

Muscle Mass

Muscle mass will be measured at several time points during the patient stay.

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

Muscle Strength

Muscle strength will be assessed using MRC scales at various time points throughout the study

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

Activities of Daily Living

The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.

Time frame: At hospital discharge (expected average 10 days)

Six Minute Walk

A 6 minute walk test administered per ATS guidelines will be undertaken by all patients prior to discharge. When possible at least 2 six minute walk tests will be administered.

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

Time to ambulation

The time needed for a patient who had previously been subjected to bed rest to ambulate will be noted through chart review and nursing interviews.

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

Data from ClinicalTrials.gov

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