不同持续时间的术前计算机认知训练对接受心脏手术的老年患者术后谵妄的影响:一项前瞻性随机对照试验的研究方案。

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL BMJ Open Pub Date : 2024-11-14 DOI:10.1136/bmjopen-2024-088163
Xinyuan Qiu, Lili Wang, Xinge Wen, Qingling Meng, Junwei Qi, Chuang Li, Hua Yin, Fei Ling, Qiao Yuhan, Wen Zhang, Yueying Zhang
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引用次数: 0

摘要

简介术后谵妄(POD)是老年患者手术后常见的神经系统并发症,主要表现为意识、注意力和认知能力的急性紊乱,通常发生在术后 24-72 小时内。POD 对接受大型心血管手术的老年患者的预后有重大影响,包括住院时间延长、住院费用增加和再入院率升高,发生率高达 26%-52%。计算机化认知训练(CCT)是指利用系统设计的任务,在注意力、记忆力和逻辑推理等认知领域进行难度适应性训练。现有研究表明,CCT 至少能降低非心脏手术患者的谵妄风险。本研究旨在探讨术前 CCT 对接受择期心脏手术的老年患者 POD 发生率的影响,明确术前 CCT 不同训练时间与 POD 之间的剂量效应关系,并探索能显著降低 POD 发生率的最小有效时间目标:这是一项前瞻性、单盲、随机对照试验,旨在招募261名计划在徐州医科大学附属医院接受择期心脏手术的老年患者。患者将被随机分为三组:C 组为常规护理组(术前不进行 CCT);L 组为低剂量时间组(术前共进行 5 小时 CCT);H 组为高剂量时间组(术前共进行 10 小时 CCT)。主要结果是术后 7 天内谵妄的发生率。次要结果包括术后轻度神经认知障碍(NCD)和术后重度神经认知障碍(30 天至 1 年)、谵妄的发生时间、持续时间和严重程度以及术后 1 年内的全因死亡率。这项研究的结果对于建立有效的、以患者为中心的、低风险的术前/术后NCD预防策略具有重要意义:本研究方案已获徐州医科大学附属医院伦理委员会批准(伦理编号:XYFY2023-KL149-01)。所有参与者将提供书面知情同意书,研究结果将在国际同行评审的学术期刊上发表,并在学术会议上展示:试验注册号:ChiCTR2300072806。
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Effect of different durations of preoperative computerised cognitive training on postoperative delirium in older patients undergoing cardiac surgery: a study protocol for a prospective, randomised controlled trial.

Introduction: Postoperative delirium (POD) is a common neurological complication after surgery among older patients, characterised by acute disturbances in consciousness, attention and cognition, usually occurring within 24-72 hours after surgery. POD has a significant impact on the prognosis of older patients undergoing major cardiovascular surgery, including increased length of hospital stay, hospital costs and readmission rates, with an incidence rate as high as 26%-52%. Computerised cognitive training (CCT) refers to difficulty-adaptive training in cognitive domains such as attention, memory and logical reasoning, using systematically designed tasks. Existing studies have shown that CCT has reduced the risk of delirium in non-cardiac surgery patients with at least minimal compliance. The purpose of this study is to investigate the effects of preoperative CCT on the incidence of POD in older patients undergoing elective cardiac surgery, to clarify the dose-effect relationship between different training time of preoperative CCT and POD and to explore the minimum effective time target that can significantly lower the incidence of POD.

Methods and analysis: This is a prospective, single-blind, randomised controlled trial that aims to enrol 261 older patients scheduled for elective cardiac surgery at the Affiliated Hospital of Xuzhou Medical University. The patients will be randomised into three groups: group C will be the routine care group (no CCT prior to surgery); group L will be the low-dose time group (with a total of 5 hours of CCT prior to surgery) and group H will be the high-dose time group (with a total of 10 hours of CCT prior to surgery). The primary outcome is the incidence of delirium within 7 days after surgery. Secondary outcomes include postoperative mild neurocognitive disorder (NCD) and postoperative major NCD (30 days up to 1 year), time of onset and duration and severity of delirium, and all-cause mortality within 1 year after surgery. The results of this study are of significant importance for establishing effective, patient-centred and low-risk prevention strategies for POD/postoperative NCD.

Ethics and dissemination: This study protocol has been approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University (Ethics Number: XYFY2023-KL149-01). All participants will provide written informed consent, and the results of the study will be published in international peer-reviewed academic journals and presented at academic conferences.

Trial registration number: ChiCTR2300072806.

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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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