Centre for Care Excellence, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
Centre for Care Excellence, Coventry University, Coventry, UK.
BMJ Open. 2023 Feb 3;13(2):e066143. doi: 10.1136/bmjopen-2022-066143.
Delirium is common in critically ill patients and is associated with longer hospital stays, increased mortality and higher healthcare costs. A number of risk factors have been identified for the development of delirium in intensive care, two of which are sleep disturbance and immobilisation. Non-pharmacological interventions for the management of intensive care unit (ICU) delirium have been advocated, including sleep protocols and early mobilisation. However, there is a little published evidence evaluating the feasibility and acceptability of evening mobilisation.
Mobilisation in the EveNing to TreAt deLirium (MENTAL) is a two-centre, mixed-methods feasibility randomised controlled trial (RCT). Sixty patients will be recruited from ICUs at two acute NHS trusts and randomised on a 1:1 basis to receive additional evening mobilisation, delivered between 19:00 and 21:00, or standard care. The underpinning hypothesis is that the physical exertion associated with evening mobilisation will promote better sleep, subsequently having the potential to reduce delirium incidence. The primary objective is to assess the feasibility and acceptability of a future, multicentre RCT. The primary outcome measures, which will determine feasibility, are recruitment and retention rates, and intervention fidelity. Acceptability of the intervention will be evaluated through semi-structured interviews of participants and staff. Secondary outcome measures include collecting baseline, clinical and outcome data to inform the power calculations of a future definitive trial.
Ethical approval has been obtained through the Wales Research and Ethics Committee 6 (22/WA/0106). Participants are required to provide written informed consent. We aim to disseminate the findings through international conferences, international peer-reviewed journals and social media.
NCT05401461.
在危重病患者中，谵妄很常见，与住院时间延长、死亡率增加和医疗保健费用增加有关。已经确定了一些与重症监护中发生谵妄相关的危险因素，其中两个是睡眠障碍和固定不动。已经提倡使用非药物干预措施来管理重症监护病房（ICU）谵妄，包括睡眠方案和早期活动。然而，评估傍晚活动对 ICU 谵妄的可行性和可接受性的证据很少。
在傍晚活动治疗谵妄（MENTAL）中，将在两家 NHS 急性信托基金的 ICU 中招募 60 名患者，并按照 1:1 的比例随机分配接受额外的傍晚活动，活动时间在 19:00 至 21:00 之间，或标准护理。其基本假设是傍晚活动所带来的身体劳累会促进更好的睡眠，从而有可能降低谵妄的发生率。主要目标是评估未来多中心 RCT 的可行性和可接受性。主要结局指标是确定可行性的招募和保留率以及干预的一致性。通过对参与者和工作人员进行半结构化访谈来评估干预措施的可接受性。次要结局指标包括收集基线、临床和结局数据，为未来的确定性试验提供力量计算。
已经通过威尔士研究和伦理委员会 6（22/WA/0106）获得了伦理批准。参与者需要提供书面知情同意书。我们的目标是通过国际会议、国际同行评审期刊和社交媒体来传播研究结果。
NCT05401461。
