Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment

Michelle E Kho; Alexander D Truong; Jennifer M Zanni; Nancy D Ciesla; Roy G Brower; Jeffrey B Palmer; Dale M Needham

doi:10.1016/j.jcrc.2014.09.014

Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment

J Crit Care. 2015 Feb;30(1):32-9. doi: 10.1016/j.jcrc.2014.09.014. Epub 2014 Sep 22.

Authors

Michelle E Kho¹, Alexander D Truong², Jennifer M Zanni³, Nancy D Ciesla⁴, Roy G Brower⁵, Jeffrey B Palmer⁶, Dale M Needham⁷

Affiliations

¹ Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada L8S 1C7. Electronic address: khome@mcmaster.ca.
² Pulmonary, Allergy, and Critical Care Medicine, Emory University, Atlanta, GA 30308.
³ Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; Department of Physical Medicine and Rehabilitation, Johns Hopkins Hospital, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.
⁴ Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.
⁵ Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287.
⁶ Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287.
⁷ Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, MD 21287; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD 21287; Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, MD 21287.

Abstract

Purpose: The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients.

Materials and methods: We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124.

Results: We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019).

Conclusions: In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research.

Keywords: Critical illness; Electric stimulation; Intensive care units; Muscle; Randomized controlled trial; Respiration artificial.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Early Termination of Clinical Trials
Electric Stimulation
Electric Stimulation Therapy / methods*
Female
Humans
Intensive Care Units
Lower Extremity / physiology
Male
Middle Aged
Muscle Strength / physiology*
Outcome Assessment, Health Care
Patient Discharge
Patient Selection
Pilot Projects
Respiration, Artificial*
Time Factors
Walking

Associated data

ClinicalTrials.gov/NCT00709124

Abstract

Publication types

MeSH terms

Associated data

Grants and funding