Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark.
Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Regional Health Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark.
J Crit Care. 2021 Apr;62:58-64. doi: 10.1016/j.jcrc.2020.11.017. Epub 2020 Nov 24.
Critical illness impairs physical function. The NONSEDA trial was a multicenter randomized trial, assessing non-sedation versus sedation during mechanical ventilation. The aim of this sub-study was to assess the effect of non-sedation on physical function.
All patients from one NONSEDA trial site were included. At ICU discharge and three months thereafter, survivors were assessed for physical function.
205 patients were included, 118 survived to follow-up, 116 participated (98%).
Three months after ICU-discharge, health-related quality of life (SF-36, physical component score) was similar (non-sedated 38.3 vs sedated 36.6, mean difference 1.7, 95% CI -1.7 to 5.1), as was function in activities of daily living (Barthel Index, non-sedated 19.5 vs sedated 18, median difference 1.5, 95% CI -0.2 to 3.2).
Non-sedated patients had a better Barthel Index at ICU-discharge (median 9 vs 4, median difference 5, 95% CI 2.5 to 7.5). At three months post-ICU discharge, the two groups did not differ regarding handgrip strength, walking distance, muscle size or biomechanical data.
Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living. Non-sedated patients had a better physical recovery at ICU discharge.
Clinicaltrials.govNCT02034942, registered January 14., 2014.
危重病会损害身体功能。NONSEDA 试验是一项多中心随机试验，评估机械通气期间的非镇静与镇静。本研究的目的是评估非镇静对身体功能的影响。
纳入了来自 NONSEDA 试验的一个中心的所有患者。在 ICU 出院时和之后三个月，对幸存者进行身体功能评估。
共纳入 205 例患者，118 例存活至随访，116 例（98%）参与。
ICU 出院后三个月，健康相关生活质量（SF-36，生理成分评分）相似（非镇静组 38.3 分，镇静组 36.6 分，平均差异 1.7，95%CI-1.7 至 5.1），日常生活活动能力（Barthel 指数，非镇静组 19.5 分，镇静组 18 分，中位数差异 1.5，95%CI-0.2 至 3.2）也相似。
非镇静组 ICU 出院时的 Barthel 指数更好（中位数 9 分，中位数差异 5 分，95%CI 2.5 至 7.5）。在 ICU 出院后三个月，两组在手握力、步行距离、肌肉大小或生物力学数据方面没有差异。
非镇静并未改善身体功能相关的生活质量或日常生活活动能力。非镇静组 ICU 出院时的身体恢复更好。
Clinicaltrials.govNCT02034942，2014 年 1 月 14 日注册。
