电刺激对2019新型冠状病毒肺炎重症监护病房患者下肢肌肉无力的安全性和有效性：一项I期双盲随机对照试验。
Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial.
作者信息
Zulbaran-Rojas Alejandro, Mishra Ramkinker, Rodriguez Naima, Bara Rasha O, Lee Myeounggon, Bagheri Amir Behzad, Herlihy James P, Siddique Muhammad, Najafi Bijan
机构信息
Interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, United States.
Department of Pulmonary Critical Care, Baylor College of Medicine, Houston, TX, United States.
出版信息
Front Med (Lausanne). 2022 Dec 6;9:1017371. doi: 10.3389/fmed.2022.1017371. eCollection 2022.
BACKGROUND
Intensive care unit (ICU) prolonged immobilization may lead to lower-extremity muscle deconditioning among critically ill patients, particularly more accentuated in those with 2019 Novel Coronavirus (COVID-19) infection. Electrical stimulation (E-Stim) is known to improve musculoskeletal outcomes. This phase I double-blinded randomized controlled trial examined the safety and efficacy of lower-extremity E-Stim to prevent muscle deconditioning.
METHODS
Critically ill COVID-19 patients admitted to the ICU were randomly assigned to control (CG) or intervention (IG) groups. Both groups received daily E-Stim (1 h) for up to 14 days on both gastrocnemius muscles (GNMs). The device was functional in the IG and non-functional in the CG. Primary outcomes included ankle strength (Ankle) measured by an ankle-dynamometer, and GNM endurance (GNM) in response to E-Stim assessed with surface electromyography (sEMG). Outcomes were measured at baseline, 3 and 9 days.
RESULTS
Thirty-two (IG = 16, CG = 16) lower extremities in 16 patients were independently assessed. The mean time between ICU admission and E-Stim therapy delivery was 1.8 ± 1.9 days ( = 0.29). At 3 days, the IG showed an improvement compared to the CG with medium effect sizes for Ankle ( = 0.06, Cohen's = 0.77) and GNM ( = 0.06, = 0.69). At 9 days, the IG GNM was significantly higher than the CG ( = 0.04, = 0.97) with a 6.3% improvement from baseline ( = 0.029). E-Stim did not alter vital signs (i.e., heart/respiratory rate, blood saturation of oxygen), showed no adverse events (i.e., pain, skin damage, discomfort), nor interfere with ICU standard of care procedures (i.e., mechanical ventilation, prone rotation).
CONCLUSION
This study supports the safety and efficacy of early E-Stim therapy to potentially prevent deterioration of lower-extremity muscle conditions in critically ill COVID-19 patients recently admitted to the ICU. If confirmed in a larger sample, E-Stim may be used as a practical adjunctive therapy.
CLINICAL TRIAL REGISTRATION
[https://clinicaltrials.gov/], identifier [NCT04685213].
背景
重症监护病房（ICU）长期制动可能导致危重症患者下肢肌肉失用，在2019新型冠状病毒（COVID-19）感染患者中表现得尤为明显。已知电刺激（E-Stim）可改善肌肉骨骼状况。本I期双盲随机对照试验研究了下肢E-Stim预防肌肉失用的安全性和有效性。
方法
入住ICU的危重症COVID-19患者被随机分配至对照组（CG）或干预组（IG）。两组均对双侧腓肠肌（GNM）进行每日1小时的E-Stim治疗，持续1�天。该设备在IG组中起作用而在CG组中不起作用。主要结局包括用踝部测力计测量的踝关节力量（Ankle），以及用表面肌电图（sEMG）评估的对E-Stim反应的GNM耐力（GNM）。在基线、第3天和第9天测量结局。
结果
对16例患者的32条下肢（IG = 16，CG = 16）进行了独立评估。入住ICU至开始E-Stim治疗的平均时间为1.8±1.9天（ = 0.29）。在第3天，与CG组相比，IG组在踝关节力量（ = 0.06，科恩d = 0.77）和GNM（ = 0.06， = 0.69）方面有中等效应量的改善。在第9天，IG组的GNM显著高于CG组（ = 0.04， = 0.97），较基线改善了6.3%（ = 0.029）。E-Stim未改变生命体征（即心率/呼吸频率、血氧饱和度）未出现不良事件（即疼痛、皮肤损伤、不适），也未干扰ICU的标准护理程序（即机械通气、俯卧位翻身）。
结论
本研究支持早期E-Stim治疗在预防近期入住ICU的危重症COVID-19患者下肢肌肉状况恶化方面的安全性和有效性。如果在更大样本中得到证实，E-Stim可作为一种实用的辅助治疗方法。
临床试验注册
[https://clinicaltrials.gov/]，标识符 [NCT04685213]。
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