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

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ClinicalTrials.gov Identifier: NCT02706587
Recruitment Status : Unknown
Verified September 2016 by Institut Mutualiste Montsouris.
Recruitment status was:  Recruiting
First Posted : March 11, 2016
Last Update Posted : September 13, 2016
Sponsor:
Collaborators:
Fondation Paul Bennetot
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Tracking Information
First Submitted Date  ICMJE February 10, 2016
First Posted Date  ICMJE March 11, 2016
Last Update Posted Date September 13, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
Medical resuscitation council (MRC) score [ Time Frame: up to 25 months. From date of randomization to the date of ICU discharge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
  • Total duration of mechanical ventilation (days) [ Time Frame: 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 ]
  • Type of hospital discharge [ Time Frame: up to 25 months. From date of randomization to the date of hospital discharge ]
    (alive/deceased/rehabilitation/home...)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment
Official Title  ICMJE Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
Brief Summary 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.
Detailed Description Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Polyneuropathy, Critical Illness
Intervention  ICMJE
  • 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.
  • Device: Sham control
    No electrostimulation
Study Arms  ICMJE
  • 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.
    Intervention: Device: Neuromuscular electrical stimulation
  • Sham Comparator: Sham Control
    No electrostimulation
    Intervention: Device: Sham control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 7, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02706587
Other Study ID Numbers  ICMJE REA 01-2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Mutualiste Montsouris
Study Sponsor  ICMJE Institut Mutualiste Montsouris
Collaborators  ICMJE
  • Fondation Paul Bennetot
  • Assistance Publique - Hôpitaux de Paris
Investigators  ICMJE
Principal Investigator: Christian Lamer, MD Institut Mutualiste Montsouris, Paris, France
PRS Account Institut Mutualiste Montsouris
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP