Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

Institut Mutualiste Montsouris1 site in 1 country102 target enrollmentMarch 2016

ConditionsPolyneuropathy, Critical Illness

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Polyneuropathy, Critical Illness
Sponsor: Institut Mutualiste Montsouris
Enrollment: 102
Locations: 1
Primary Endpoint: Medical resuscitation council (MRC) score
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

June 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Institut Mutualiste Montsouris

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Medical resuscitation council (MRC) score

Time Frame: up to 25 months. From date of randomization to the date of ICU discharge

Secondary Outcomes

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)