Mobilisation during critical illness is now included in multiple clinical practice guidelines. However, a large, randomised trial and systematic review have recently identified an increased probability of adverse events and mortality in patients who received early active mobilisation in the intensive care unit (ICU). We aimed to determine the effects of mobilisation compared with usual care on adverse events and mortality in an acute ICU setting. In subgroup analyses, we specifically aimed to investigate possible sources of harm, including the timing and duration of mobilisation achieved, ventilation status, and admission diagnosis. In this systematic review with frequentist and Bayesian analyses, we searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, CINAHL, SPORTDiscus, SCOPUS, Web of Science, and PEDro electronic databases, as well as clinical trial registries (ICTRP and ), from inception to March 16, 2023, without language restrictions. Eligible studies were randomised controlled trials that examined active mobilisation compared with either no mobilisation or mobilisation commencing later, or at a lower frequency or intensity, in adults who were critically ill during or after a period of mechanical ventilation in an acute ICU setting. Two authors independently screened reports, extracted data, and assessed the risk of bias using the Cochrane risk-of-bias tool (version 1). The primary outcome was the number of adverse events that occurred during the implementation of mobilisation, with the effect of mobilisation on mortality being the secondary outcome. Risk ratios (RRs) with 95% CIs were calculated in R (version 4.0.3) using random-effects modelling, with Bayesian analysis completed to calculate the probability of treatment harm (ie, RR >1). Subgroup analyses were completed to investigate the association of various factors of mobilisation on adverse events and mortality: duration of mobilisation (longer [≥20 min per day] shorter [<20 min per day]), timing of commencement (early [≤72 h from ICU admission] late [>72 h from ICU admission]), ventilation status at commencement (all patients mechanically ventilated all patients extubated), and ICU admission diagnosis (surgical medical). This study was registered with PROSPERO, CRD42022369272. After title and abstract screening of 14 440 studies and review of 466 full texts, 67 trials with 7004 participants met inclusion criteria, with 59 trials contributing to the meta-analysis. Of the 67 included studies, 15 (22%) did not mention adverse events and 13 (19%) reported no adverse events occurring across the trial period. Overall, we found no effect of mobilisation compared with usual care on the occurrence of adverse events (RR 1·09 [95% CI 0·69–1·74], p=0·71; 91%; 32 731 events, 20 studies; very low certainty), with a 2·96% occurrence rate (693 events in 23 395 intervention sessions; 25 studies). Mobilisation did not have any effect on mortality (RR 0·98 [95% CI 0·87–1·12], p=0·81; 0%; n=6218, 58 studies; moderate certainty). Subgroup analysis was hindered by the large amount of data that could not be allocated and analysed, making the results hypothesis generating only. Implementation of mobilisation in the ICU was associated with a less than 3% chance of an adverse event occurring and was not found to increase adverse events or mortality overall, providing reassurance for clinicians about the safety of performing this intervention. Subgroup analyses did not clearly identify any specific variable of mobilisation implementation that increased harm. None.

中文翻译：

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重症监护室需要机械通气的患者主动活动变量与不良事件和死亡率的关联：系统评价和荟萃分析

危重疾病期间的活动现已包含在多个临床实践指南中。然而，一项大型随机试验和系统评价最近发现，在重症监护病房 (ICU) 接受早期主动活动的患者发生不良事件和死亡率的可能性增加。我们的目的是确定与常规护理相比，活动对急性 ICU 环境中不良事件和死亡率的影响。在亚组分析中，我们特别旨在调查可能的伤害来源，包括实现动员的时间和持续时间、通气状态和入院诊断。在这篇使用频率论和贝叶斯分析的系统综述中，我们检索了 MEDLINE、Embase、Cochrane 对照试验中央注册库、CINAHL、SPORTDiscus、SCOPUS、Web of Science 和 PEDro 电子数据库以及临床试验注册中心（ICTRP 和 ），有效期至 2023 年 3 月 16 日，无语言限制。符合条件的研究是随机对照试验，在急性 ICU 环境中机械通气期间或之后病情危重的成人中，检查主动活动与不活动或稍后开始活动或较低频率或强度的比较。两位作者独立筛选报告、提取数据并使用 Cochrane 偏倚风险工具（第 1 版）评估偏倚风险。主要结果是动员实施期间发生的不良事件的数量，次要结果是动员对死亡率的影响。使用随机效应模型在 R（版本 4.0.3）中计算具有 95% CI 的风险比 (RR)，并完成贝叶斯分析以计算治疗伤害的概率（即 RR >1）。完成亚组分析以调查各种动员因素与不良事件和死亡率之间的关联：动员持续时间（较长[每天≥20分钟]较短[每天<20分钟]）、开始时间（早期[≤72小时]从 ICU 入院起]晚[从 ICU 入院起>72 小时]）、开始时的通气状态（所有患者机械通气、所有患者拔管）、以及 ICU 入院诊断（外科医疗）。本研究已在 PROSPERO 注册，CRD42022369272。经过对 14 440 项研究的标题和摘要筛选以及对 466 篇全文的审查后，涉及 7004 名受试者的 67 项试验符合纳入标准，其中 59 项试验有助于荟萃分析。在 67 项纳入的研究中，15 项 (22%) 没有提及不良事件，13 项 (19%) 报告在试验期间没有发生不良事件。总体而言，我们发现与常规护理相比，活动对不良事件的发生没有影响（RR 1·09 [95% CI 0·69–1·74]，p=0·71；91%；32 731 起事件，20研究；非常低的确定性），发生率为 2·96%（23 395 次干预中的 693 起事件；25 项研究）。动员对死亡率没有任何影响（RR 0·98 [95% CI 0·87–1·12]，p=0·81；0%；n=6218，58 项研究；中等确定性）。大量数据无法分配和分析，阻碍了亚组分析，导致结果仅产生假设。在 ICU 中实施动员与不良事件发生的几率低于 3%，并且未发现总体上会增加不良事件或死亡率，这为临床医生提供了关于执行此干预措施的安全性的保证。亚组分析没有明确识别动员实施中任何增加伤害的具体变量。没有任何。