重症患者强化与标准物理康复治疗对比试验（EPICC）：一项多中心、平行分组、随机对照试验。

Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial.

机构信息

Perioperative and Critical Care Directorate, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Department of Physiotherapy, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

出版信息

Thorax. 2018 Mar;73(3):213-221. doi: 10.1136/thoraxjnl-2016-209858. Epub 2017 Aug 5.

BACKGROUND

Early physical rehabilitation in the intensive care unit (ICU) has been shown to improve short-term clinical outcomes but long-term benefit has not been proven and the optimum intensity of rehabilitation is not known.

METHODS

We conducted a randomised, parallel-group, allocation-concealed, assessor-blinded, controlled trial in patients who had received at least 48 hours of invasive or non-invasive ventilation. Participants were randomised in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence. The intervention group had a target of 90 min physical rehabilitation per day, the control group a target of 30 min per day (both Monday to Friday). The primary outcome was the Physical Component Summary (PCS) measure of SF-36 at 6 months.

RESULTS

We recruited 308 participants over 34 months: 150 assigned to the intervention and 158 to the control group. The intervention group received a median (IQR) of 161 (67-273) min of physical rehabilitation on ICU compared with 86 (31-139) min in the control group. At 6 months, 62 participants in the intervention group and 54 participants in the control group contributed primary outcome data. In the intervention group, 43 had died, 11 had withdrawn and 34 were lost to follow-up, while in the control group, 56 had died, 5 had withdrawn and 43 were lost to follow-up. There was no difference in the primary outcome at 6 months, mean (SD) PCS 37 (12.2) in the intervention group and 37 (11.3) in the control group.

CONCLUSIONS

In this study, ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation.

TRIAL REGISTRATION NUMBER

ISRCTN 20436833.

背景

重症监护病房（ICU）早期的身体康复已被证明可改善短期临床结局，但长期益处尚未得到证实，且最佳康复强度也尚不清楚。

方法

我们对至少接受了 48 小时有创或无创通气的患者进行了一项随机、平行分组、分配隐藏、评估者盲法、对照试验。参与者以 1:1 的比例随机分组，按 ICU 入院、入院类型和独立性水平分层。干预组的目标是每天进行 90 分钟的身体康复，对照组的目标是每天 30 分钟（均为周一至周五）。主要结局是 6 个月时 SF-36 的生理成分综合评分（PCS）。

结果

我们在 34 个月内招募了 308 名参与者：150 名被分配到干预组，158 名被分配到对照组。与对照组（86（31-139）min）相比，干预组在 ICU 接受了中位数（IQR）为 161（67-273）min 的康复治疗。在 6 个月时，干预组有 62 名参与者和对照组有 54 名参与者提供了主要结局数据。在干预组中，43 人死亡，11 人退出，34 人失访，而在对照组中，56 人死亡，5 人退出，43 人失访。在 6 个月时，主要结局没有差异，干预组的平均（SD）PCS 为 37（12.2），对照组为 37（11.3）。