Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment
ENS
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 13, 2016
September 1, 2016
2.1 years
February 10, 2016
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medical resuscitation council (MRC) score
up to 25 months. From date of randomization to the date of ICU discharge
Secondary Outcomes (3)
Total duration of mechanical ventilation (days)
up to 25 months. From date of randomization to the date of ICU discharge
Length of ICU stay and hospital stay.
up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge
Type of hospital discharge
up to 25 months. From date of randomization to the date of hospital discharge
Study Arms (2)
Neuromuscular electrical stimulation
EXPERIMENTALNEMS 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 Control
SHAM COMPARATORNo electrostimulation
Interventions
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.
Eligibility Criteria
You may qualify if:
- All patient
- Aged of 18 or more
- With an intended ICU stay of at least 72 hours
- Mechanically ventilated
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Mutualiste Montsourislead
- Fondation Paul Bennetotcollaborator
- Assistance Publique - Hôpitaux de Pariscollaborator
Study Sites (1)
Insitut Mutualiste Montsouris
Paris, 75014, France
Related Publications (4)
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.
PMID: 20426834BACKGROUNDKress 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.
PMID: 24758618BACKGROUNDNeedham 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.
PMID: 20046132BACKGROUNDKho 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.
PMID: 22421734BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Lamer, MD
Institut Mutualiste Montsouris, Paris, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2016
First Posted
March 11, 2016
Study Start
March 1, 2016
Primary Completion
April 1, 2018
Study Completion
June 1, 2018
Last Updated
September 13, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share