NMES in Critically Ill Patients (NESCI)

Neuromuscular Electrical Stimulation in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critically Ill Patients With a Predicted Prolonged ICU Stay
• Intervention / Treatment: Other: electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: electrical stimulation; Compex 3 professional NMES for 60' per day	Other: electrical stimulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KU Leuven

Publications and helpful links

General Publications

• Segers J, Vanhorebeek I, Langer D, Charususin N, Wei W, Frickx B, Demeyere I, Clerckx B, Casaer M, Derese I, Derde S, Pauwels L, Van den Berghe G, Hermans G, Gosselink R. Early neuromuscular electrical stimulation reduces the loss of muscle mass in critically ill patients - A within subject randomized controlled trial. J Crit Care. 2021 Apr;62:65-71. doi: 10.1016/j.jcrc.2020.11.018. Epub 2020 Nov 28.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: u0064027