Snelson Catherine, Jones Charlotte, Atkins Gemma, Hodson James, Whitehouse Tony, Veenith Tonny, Thickett David, Reeves Emma, McLaughlin Aisling, Cooper Lauren, McWilliams David
Department of Critical Care, University Hospitals Birmingham NHS Foundation Trust, Edgbaston, Birmingham, UK.
Therapy Services, University Hospitals Birmingham NHS Foundation Trust, Edgbaston, Birmingham, UK.
Pilot Feasibility Stud. 2017 Apr 17;3:19. doi: 10.1186/s40814-017-0131-1. eCollection 2017.
Mortality from critical illness is improving, but survivors suffer from prolonged weakness and psychological and cognitive impairments. Maximising the recovery after critical illness has been highlighted as a research priority, especially in relation to an ageing population who present with higher rates of pre-morbid disability. Small studies have shown that starting rehabilitation early within the intensive care unit (ICU) improves short-term outcomes. Systematic reviews have highlighted the need for robust multicentre randomised controlled trials with longer term follow-up.
The study design is a randomised controlled study to explore the feasibility of providing earlier and enhanced rehabilitation to mechanically ventilated patients at high risk of ICU-acquired weakness within the ICU. The rehabilitation intervention involves a structured programme, with progression along a functionally based mobility protocol according to set safety criteria. The overall aim of the intervention is to commence mobilisation at an earlier time point in the patient's illness and increase mobility of the patient through their recovery trajectory. Participants will be randomised to enhanced rehabilitation or standard care, with the aim of recruiting at least 100 patients over 16 months. The trial design will assess recruitment and consent rates from eligible patients, compliance with the intervention, and assess a range of possible outcome measures for use in a definitive trial, with follow-up continuing for 12 months post hospital discharge.
This study will evaluate the feasibility of providing an earlier and enhanced rehabilitation intervention to mechanically ventilated patients in critical care. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from this study will inform the design of a phase III multicentre trial of enhanced rehabilitation for critically ill adults.
ISRCTN90103222, 13/08/2015; retrospectively registered.
危重症患者的死亡率正在下降，但幸存者仍长期存在身体虚弱以及心理和认知障碍问题。提高危重症后的康复效果已被视为一项研究重点，尤其是对于患有较高病前残疾率的老年人群体而言。小型研究表明，在重症监护病房（ICU）内尽早开始康复治疗可改善短期预后。系统评价强调了开展具有长期随访的强有力的多中心随机对照试验的必要性。
本研究设计为一项随机对照研究，旨在探讨在ICU内为有发生ICU获得性肌无力高风险的机械通气患者提供更早、更强化康复治疗的可行性。康复干预包括一个结构化方案，根据设定的安全标准，按照基于功能的活动方案逐步推进。干预的总体目标是在患者病程中更早的时间点开始活动，并通过其康复轨迹提高患者的活动能力。参与者将被随机分配至强化康复组或标准治疗组，目标是在16个月内招募至少100名患者。试验设计将评估符合条件患者的招募和同意率、对干预措施的依从性，并评估一系列可能用于确定性试验的结局指标，出院后随访持续12个月。
本研究将评估在重症监护中为机械通气患者提供更早、更强化康复干预的可行性。我们将确定拟议方案的优缺点以及结局指标的实用性和特征。本研究结果将为针对危重症成人的强化康复的III期多中心试验设计提供信息。
ISRCTN90103222，2015年8月13日；追溯注册。
