Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Polyneuropathy, Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type DEVICE

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

No electrostimulation

Group Type SHAM_COMPARATOR

Sham control

Intervention Type DEVICE

No electrostimulation

Interventions

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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.

Intervention Type DEVICE

Sham control

No electrostimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No