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

Institut Mutualiste Montsouris

Status and phase: Unknown; Phase 3

Conditions: Polyneuropathy, Critical Illness

Treatments: Device: Neuromuscular electrical stimulation; Device: Sham control

Study type: Interventional

Funder types: Other

Identifiers

NCT02706587

REA 01-2014

Details and patient eligibility

About

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.

Full description

Randomized, controlled study of early electrical neurostimulation (vs sham) in critically ill patients.

Enrollment: 102 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Neuromuscular electrical stimulation

Experimental group

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.

Treatment:

Device: Neuromuscular electrical stimulation

Sham Control

Sham Comparator group

Description:

No electrostimulation

Treatment:

Device: Sham control