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Intensive Care Unit | Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

Intensive Care Unit research study

What is the primary objective of this study?

The purpose of this study is to investigate whether neuromuscular electrostimulation (NMES) will decrease ICU-associated weakness. The investigators believe that 60 minutes of daily NMES will improve strength and function in those who have had extended ICU stays, as well as decrease critical illness myopathy as an etiology of weakness in the critically ill.

Who is eligible to participate?

Inclusion Criteria: - 1 day of mechanical ventilation with an expectation of requiring ≥2 additional days of ICU stay in a Johns Hopkins Intensive Care Unit (ICU) Exclusion Criteria: - Unable to understand or speak English due to language barrier or cognitive impairment prior to admission - Unable to independently transfer from bed to chair at baseline prior to hospital admission - Known primary systemic neuromuscular disease (e.g. Guillian-Barre) at ICU admission - Known intracranial process that is associated with localizing weakness (e.g. cerebral vascular accident) at ICU admission - Transferred from another ICU outside of the Johns Hopkins system after >4 consecutive days of mechanical ventilation - Moribund (i.e. >90% probability of patient mortality in the next 96 hours) - Anticipated transfer to another ICU for care (e.g. awaiting organ transplantation and transfer to surgical ICU) - Any pacemaker (e.g., cardiac, diaphragm) or implanted cardiac defibrillator - Pregnancy - Body mass index ≥35 kg/m2 - Any limitation in life support other than a sole no-CPR order - Known or suspected malignancy in the legs - Unable to treat or evaluate both lower extremities (e.g., bilateral amputation, bilateral skin lesions) - ICU length of stay >7 days prior to enrollment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Intensive Care Unit

Muscle Weakness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Neuromuscular Electrostimulation (NMES) CareStim Muscle Stimulation Device (Care Rehab; McLean, VA)60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay.

Device:Sham60 minute NMES sessions will be applied to three muscle groups of the lower extremities (quadriceps, pretibial, and triceps surae). Sessions start at study entry, and will occur every day for the duration of subject's ICU stay. Sham groups will NOT have voltage applied.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NMES60 minute daily NMES sessions every day for the duration of subject's ICU stay.

Sham60 minute sham sessions every day for the duration of subjects ICU stay. No voltage will be applied to those receiving sham sessions.

Study Status

Completed

Start Date: June 2008

Completed Date: April 2013

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Lower Extremity Strength, at Hospital Discharge, of 3 Bilateral Muscle Groups (Pretibial, Triceps Surae, and Quadriceps) Measured Via MMT Using a Composite Medical Research Council (MRC) Score

Secondary Outcome: Individual Muscle Strength: Pretibial, Triceps Surae, and Quadriceps (MRC Score) Between Those Who Receive NMES vs. Sham Sessions

Study sponsors, principal investigator, and references

Principal Investigator: Dale Needham, MD, PhD

Lead Sponsor: Johns Hopkins University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT00709124

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