NMES in Critically Ill Patients (NESCI)

Catholic University (KU) of Leuven

Status: Completed

Conditions: Critically Ill Patients With a Predicted Prolonged ICU Stay

Treatments: Other: electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02133300

u0064027

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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50 participants in 2 patient groups

electrical stimulation

Experimental group

Description:

Compex 3 professional NMES for 60' per day

Treatment:

Other: electrical stimulation

control

No Intervention group