Clinical trial NCT02706587: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment
Official title: Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Polyneuropathy, Critical Illness
Keywords: Critical illness polyneuropathy
Neuromuscular Electrical Stimulation
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
Collaborators: name: Fondation Paul Bennetot
name: Assistance Publique - Hôpitaux de Paris
First posted: 2016-03-11
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Medical resuscitation council (MRC) score
timeFrame: up to 25 months. From date of randomization to the date of ICU discharge
Secondary outcomes:
measure: Total duration of mechanical ventilation (days)
timeFrame: up to 25 months. From date of randomization to the date of ICU discharge
measure: Length of ICU stay and hospital stay.
timeFrame: up to 25 months. From date of randomization to the date of ICU discharge or hospital discharge
measure: Type of hospital discharge
timeFrame: up to 25 months. From date of randomization to the date of hospital discharge
Other outcomes:
Locations:
city: Paris
country: France
facility: Insitut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris, Paris, France
name: Christian Lamer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.