Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment (ENS)

September 12, 2016 updated by: Institut Mutualiste Montsouris

Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

The purpose of this study is to determine whether early neuromuscular electrical stimulation is effective in the prevention of neuromuscular weakness in critical ill patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Insitut Mutualiste Montsouris
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patient
  • Aged of 18 or more
  • With an intended ICU stay of at least 72 hours
  • Mechanically ventilated

Exclusion Criteria:

  • Age less than 18 years
  • Pregnant women
  • Preexisting neuromuscular disease
  • Patient bearing a pace maker or an implantable defibrillator.
  • Poly traumatism and/or leg fracture.
  • End stage disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
Device: Neuromuscular electrical stimulation
NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
Sham Comparator: Sham Control
No electrostimulation
Device: Sham control
No electrostimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medical resuscitation council (MRC) score
Time Frame: up to 25 months. From date of randomization to the date of ICU discharge
up to 25 months. From date of randomization to the date of ICU discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of mechanical ventilation (days)
Time Frame: up to 25 months. From date of randomization to the date of ICU discharge
up to 25 months. From date of randomization to the date of ICU discharge
Length of ICU stay and hospital stay.
Time Frame: up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge
up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge
Type of hospital discharge
Time Frame: up to 25 months. From date of randomization to the date of hospital discharge
(alive/deceased/rehabilitation/home...)
up to 25 months. From date of randomization to the date of hospital discharge

Collaborators and Investigators

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

Sponsor

Institut Mutualiste Montsouris

Collaborators

Assistance Publique - Hôpitaux de Paris
Fondation Paul Bennetot

Investigators

  • Principal Investigator: Christian Lamer, MD, Institut Mutualiste Montsouris, Paris, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REA 01-2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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