Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness Assessment

Study Overview
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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.

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

Official Title
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Neuromuscular Electrical Stimulation for Intensive Care Unit-acquired Weakness

Conditions
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Polyneuropathy, Critical Illness

Intervention / Treatment
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* Device: Neuromuscular electrical stimulation
* Device: Sham control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular electrical stimulation<br>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. | Device: Neuromuscular electrical stimulation<br>* 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.<br>|
| Sham Comparator: Sham Control<br>No electrostimulation | Device: Sham control<br>* No electrostimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical resuscitation council (MRC) score |  | up to 25 months. From date of randomization to the date of ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | (alive/deceased/rehabilitation/home...) | up to 25 months. From date of randomization to the date of hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness polyneuropathy, Neuromuscular Electrical Stimulation