Safety and Performance of Muscle Activation for Critical Care Patients

April 5, 2013 updated by: Niveus Medical, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Franklin Square Medical Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Activation Treatment
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.
NO_INTERVENTION: Usual Care
This arm will not receive any study-motivated intervention. Subjects will receive usual care, but will participate in outcomes assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle Activation Effectiveness
Time Frame: Day of ICU Discharge, expected on average 5 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle Mass
Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Muscle mass will be measured at several time points during the patient stay.
At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Muscle Strength
Time Frame: At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Muscle strength will be assessed using MRC scales at various time points throughout the study
At enrollment, at ICU discharge (expected average days), at hospital discharge (expected average 10 days)
Activities of Daily Living
Time Frame: At hospital discharge (expected average 10 days)
The subject's proficiencies and independence in Activities of Daily Living will be assessed prior to hospital discharge.
At hospital discharge (expected average 10 days)
Six Minute Walk
Time Frame: At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
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.
At time of first ambulation (expected average 7 days), at hospital discharge (expected average 10 days)
Time to ambulation
Time Frame: During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
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.
During timeframe when patient moves out of bed, expected on average 5 - 8 days into study
Length of stay
Time Frame: At end of study, expected on average after 10 days
The subject's length of stay will be recorded from chart review.
At end of study, expected on average after 10 days
Ventilator Dependency
Time Frame: During active ventilation and weaning period, expected to last on average 4 - 7 days per patient
Chart review will be used to determine the number of ventilator days and the ventilator weaning time for each subject
During active ventilation and weaning period, expected to last on average 4 - 7 days per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Niveus Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Tidswell, MD, Baystate Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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