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

Neuromuscular electrical stimulation in mechanically ventilated patients: A randomized, sham-controlled pilot trial with blinded outcome assessment
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DOI:
10.1016/j.jcrc.2014.09.014
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发表时间:
2015-02-01
影响因子:
3.7
通讯作者:
Needham, Dale M.
Needham, Dale M.
中科院分区:
医学3区
文献类型:
--
作者:
Kho, Michelle E.;Truong, Alexander D.;Needham, Dale M.

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目的:本研究的目的是比较神经肌肉电刺激(NMES)与假手术对机械通气患者出院时腿部力量的影响。材料和方法:我们在重症监护室(ICU)进行了一项随机试点研究,将NMES与假手术分别应用于3个双侧下肢肌肉群,每天60分钟。在2008年6月至2013年3月期间,我们招募了在ICU住院的第一周内接受机械通气并且在入院前能够独立从床上转移到椅子上的成年人。主要终点是出院时的下肢肌力,采用医学研究委员会评分(最高30分)。出院时的次要结局包括步行距离和ICU苏醒后下肢力量的变化。Clinicaltrials.gov: NCT00709124。结果:由于患者累积缓慢和研究经费结束,我们在36例患者后提前停止了入组。对于NMES和sham,平均(SD)下肢强度为28(2)比27 (3),P = 0.072。在次要结局中,NMES患者与假手术患者的平均步行距离(SD)更大(514[389]比251[210]英尺,P = 0.050),肌肉力量增加(5.7[5.1]比1.8 [2.7],P = 0.019)。结论:在这项随机试验中,NMES并没有显著改善出院时的腿部力量。次要结果的显著改善需要在未来的研究中进行调查。(C) 2014爱思唯尔公司版权所有。
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. (C) 2014 Elsevier Inc. All rights reserved.