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

Primary Purpose

Polyneuropathy, Critical Illness

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Neuromuscular electrical stimulation
Sham control
Sponsored by
Institut Mutualiste Montsouris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polyneuropathy, Critical Illness focused on measuring Critical illness polyneuropathy, Neuromuscular Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Insitut Mutualiste MontsourisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Neuromuscular electrical stimulation

Sham Control

Arm Description

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.

No electrostimulation

Outcomes

Primary Outcome Measures

Medical resuscitation council (MRC) score

Secondary Outcome Measures

Total duration of mechanical ventilation (days)
Length of ICU stay and hospital stay.
Type of hospital discharge
(alive/deceased/rehabilitation/home...)

Full Information

First Posted
February 10, 2016
Last Updated
September 12, 2016
Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation Paul Bennetot, Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02706587
Brief Title
Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment
Acronym
ENS
Official Title
Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Mutualiste Montsouris
Collaborators
Fondation Paul Bennetot, Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy, Critical Illness
Keywords
Critical illness polyneuropathy, Neuromuscular Electrical Stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
No electrostimulation
Intervention Type
Device
Intervention Name(s)
Neuromuscular electrical stimulation
Intervention Description
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 Type
Device
Intervention Name(s)
Sham control
Intervention Description
No electrostimulation
Primary Outcome Measure Information:
Title
Medical resuscitation council (MRC) score
Time Frame
up to 25 months. From date of randomization to the date of ICU discharge
Secondary Outcome Measure Information:
Title
Total duration of mechanical ventilation (days)
Time Frame
up to 25 months. From date of randomization to the date of ICU discharge
Title
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
Title
Type of hospital discharge
Description
(alive/deceased/rehabilitation/home...)
Time Frame
up to 25 months. From date of randomization to the date of hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Lamer, MD
Phone
+33156616188
Email
christian.lamer@imm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Celine Menez, PT
Phone
+33156616134
Email
celine.menez@imm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Lamer, MD
Organizational Affiliation
Institut Mutualiste Montsouris, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insitut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LAMER
Phone
+33156616188
Email
christian.lamer@imm.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20426834
Citation
Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E, Pitsolis T, Tripodaki E, Markaki V, Zervakis D, Nanas S. Electrical muscle stimulation prevents critical illness polyneuromyopathy: a randomized parallel intervention trial. Crit Care. 2010;14(2):R74. doi: 10.1186/cc8987. Epub 2010 Apr 28.
Results Reference
background
PubMed Identifier
24758618
Citation
Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
Results Reference
background
PubMed Identifier
20046132
Citation
Needham DM, Truong AD, Fan E. Technology to enhance physical rehabilitation of critically ill patients. Crit Care Med. 2009 Oct;37(10 Suppl):S436-41. doi: 10.1097/CCM.0b013e3181b6fa29.
Results Reference
background
PubMed Identifier
22421734
Citation
Kho ME, Truong AD, Brower RG, Palmer JB, Fan E, Zanni JM, Ciesla ND, Feldman DR, Korupolu R, Needham DM. Neuromuscular electrical stimulation for intensive care unit-acquired weakness: protocol and methodological implications for a randomized, sham-controlled, phase II trial. Phys Ther. 2012 Dec;92(12):1564-79. doi: 10.2522/ptj.20110437. Epub 2012 Mar 15.
Results Reference
background

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Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment

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