NMES in Critically Ill Patients

Study Overview
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Brief Summary
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Critically ill patients with a predicted prolonged ICU stay will receive neuromuscular electrical stimulation (NMES) of one quadriceps muscle. Whether the dominant or non-dominant side will be stimulated is chosen randomly by using opaque sealed envelopes. The patients will receive electrical stimulation for 1h for 7 consecutive days. The stimulated and non-stimulated side will be compared for it's thickness (by using ultrasound imaging), muscle strength if the patients are awake and cooperative (using the medical research council scale and handheld dynamometry) and a muscle biopsy will be taken. As a primary outcome the investigators hypothesize that electrical stimulation will preserve muscle mass with respect to the non-stimulated quadriceps. As secondary outcomes the investigators hypothesize that electrical stimulation can reduce muscle strength loss and leads to a better protein balance and thicker muscle fibers in the stimulated quadriceps.

Official Title
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Neuromuscular Electrical Stimulation in Critically Ill Patients

Conditions
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Critically Ill Patients With a Predicted Prolonged ICU Stay

Intervention / Treatment
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* Other: electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult ICU patients with a predicted prolonged ICU stay Exclusion Criteria: Preexisting neuromuscular disease, polyneuropathy or myopathy (e.g. Guillain-Barré, myasthenia gravis, Amyotrophic Lateral Sclerosis, paraplegia, multiple sclerosis, …) Receiving neuromuscular blocking agents Musculoskeletal conditions of the pelvis and/or lower limb (e.g. fractures, skin disease ) Focal neurological conditions of the pelvis and/or lower limb Skin disease (e.g. burns) Presence of a pace-maker or defibrillator Hemodynamic or Respiratory Instability, active cardiac ischemia High fever (>39°) Pregnancy Brain death Intracranial pressure >20 mmHg An anticipated fatal outcome Psychiatric disorders or severe agitation Re-admission to the ICU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical stimulation<br>Compex 3 professional NMES for 60' per day | Other: electrical stimulation<br> <br> |
| No Intervention: control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle thickness | Ultrasound measure in cm | pre-intervention period | 
| Muscle thickness | Ultrasound measure in cm | post intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength (MRC & HHD) | MRC: scale HHD: MicroFet, in kg Force | pre intervention period | 
| Muscle fiber thickness | biopsy using Bergström-Stille 5mm needles | post intervention period | 
| Muscle strength (MRC & HHD) | MRC: scale HHD: MicroFET, in kg Force | post intervention period | 
| Protein balance | biopsy using Bergström-Stille 5mm needles | post intervention |