Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment

Phase 3

• Conditions: Polyneuropathy, Critical Illness
• Interventions: Device: Neuromuscular electrical stimulation; Device: Sham control

• Registration Number: NCT02706587
• Lead Sponsor: Institut Mutualiste Montsouris

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 Timeline

• Study First Submitted: 2016-02-10
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13
• Primary Completion: 2018-04
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular electrical stimulation	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.
Sham Control	Sham control	No electrostimulation

Primary Outcome Measures

Name	Time	Method
Medical resuscitation council (MRC) score	up to 25 months. From date of randomization to the date of ICU discharge

Secondary Outcome Measures

Name	Time	Method
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	(alive/deceased/rehabilitation/home...)

Trial Locations

Locations (1)

Insitut Mutualiste Montsouris; 🇫🇷 Paris, France