School of Rehabilitation Science, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Department of Medicine, Schulich School of Medicine & Dentistry, Western University, London, ON, Canada.
Can J Anaesth. 2024 Oct;71(10):1406-1416. doi: 10.1007/s12630-024-02838-7. Epub 2024 Sep 24.
Physical rehabilitation (PR) in the intensive care unit (ICU) may improve outcomes for survivors but clinical trial results have been discordant. We hypothesized that discordant results may reflect treatment heterogeneity received by "usual care" comparator groups in PR studies. Usual-care PR is typically underspecified, which is a barrier to comparing results across treatment studies. The primary objective of the present study was to describe the usual-care PR received by critically ill patients enrolled in the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength (CYCLE) pilot randomized controlled trial (RCT) of PR. Other objectives were to help contextualize current research and provide data for international comparison.
In this secondary analysis of the CYCLE pilot RCT, patients were randomized to in-bed cycling and usual-care PR or usual-care PR alone. Physiotherapists documented usual-care PR including therapy received, type of activity, duration, adverse events and consequences, reasons for no PR, and concurrent relevant medical interventions. We characterized usual care using descriptive statistics at the cohort and patient levels.
Across seven Canadian centres, 30 patients were randomized to usual-care PR. The median [interquartile range (IQR)] ICU stay was 10 [9-24] days and patients received PR on a median [IQR] of 5 [3-9] days for 23 [17-30] min per day. Eighteen patients (60%) stood, marched, or walked during usual care. Transient adverse events occurred in three patients on 1.5% (3/198) of days and none prompted session termination.
In the usual-care arm of the CYCLE pilot RCT, PR was delivered on half of ICU days and over half of patients stood, marched, or walked. Adverse events during usual-care PR were uncommon.
ClinicalTrials.gov ( NCT02377830 ); first posted 4 March 2015.
重症监护病房（ICU）中的物理康复（PR）可能会改善幸存者的预后，但临床试验结果存在差异。我们假设，这些差异的结果可能反映了 PR 研究中“常规护理”对照组接受的治疗异质性。常规护理 PR 通常未得到明确规定，这是比较治疗研究结果的障碍。本研究的主要目的是描述参加加拿大多中心重症监护循环以改善下肢力量（CYCLE）PR 先导随机对照试验（RCT）的危重病患者接受的常规护理 PR。其他目的是帮助了解当前的研究并为国际比较提供数据。
在 CYCLE 先导 RCT 的二次分析中，患者被随机分配到卧床自行车运动和常规护理 PR 或单独接受常规护理 PR。物理治疗师记录常规护理 PR，包括接受的治疗、活动类型、持续时间、不良事件和后果、未进行 PR 的原因以及同时进行的相关医疗干预。我们使用描述性统计数据在队列和患者水平上描述了常规护理。
在七个加拿大中心，30 名患者被随机分配到常规护理 PR。中位（四分位距[IQR]）ICU 住院时间为 10 [9-24] 天，患者在中位（IQR）接受 PR 治疗 5 [3-9] 天，每天 23 [17-30] 分钟。18 名患者（60%）在常规护理期间站立、行军或行走。3 名患者在 1.5%（3/198）的天数中出现短暂不良事件，且无任何不良事件导致治疗终止。
在 CYCLE 先导 RCT 的常规护理臂中，PR 在 ICU 住院天数的一半时间内进行，超过一半的患者站立、行军或行走。常规护理 PR 期间的不良事件并不常见。
ClinicalTrials.gov（NCT02377830）；首次发布于 2015 年 3 月 4 日。
