NMES in Critically Ill Patients

Critically Ill Patients With a Predicted Prolonged ICU Stay Clinical Trial

— NESCI  

Official title:

Neuromuscular Electrical Stimulation in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133300
• Other study ID #: u0064027
• Status: Completed
• Phase: N/A
• First received: May 6, 2014
• Last updated: February 20, 2018
• Start date: May 2014
• Est. completion date: October 2017

Study information

• Verified date: February 2018
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients With a Predicted Prolonged ICU Stay

Intervention

Other:
• electrical stimulation

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle thickness	Ultrasound measure in cm	pre-intervention period
Primary	Muscle thickness	Ultrasound measure in cm	post intervention period
Secondary	Muscle strength (MRC & HHD)	MRC: scale HHD: MicroFet, in kg Force	pre intervention period
Secondary	Muscle fiber thickness	biopsy using Bergström-Stille 5mm needles	post intervention period
Secondary	Muscle strength (MRC & HHD)	MRC: scale HHD: MicroFET, in kg Force	post intervention period
Secondary	Protein balance	biopsy using Bergström-Stille 5mm needles	post intervention