Department of Anaesthesiology and Critical Care Medicine, Centre Hospitalier Universitaire (CHU) Saint-Etienne, Université Jean Monnet Saint-Etienne, Saint-Etienne, France.
Department of Perioperative Medicine, Centre Hospitalier Universitaire (CHU), Université Clermont Auvergne, Clermont-Ferrand, France.
BMJ Open. 2018 Jun 19;8(6):e021053. doi: 10.1136/bmjopen-2017-021053.
Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In adult patients, several specific intraoperative approaches such as cardiac output-guided haemodynamic therapy, depth of anaesthesia monitoring (DAM) or lung-protective ventilation (LPV) are designed to reduce postoperative mortality and surgical complications. However, none of these approaches has been specifically performed in the elderly, and no evaluation of a multimodal optimisation strategy for general anaesthesia has been achieved in this population.
The objective of this study is to assess, in high-risk patients aged 75 years and over undergoing high-risk surgery, the effectiveness of combined optimisation of anaesthesia involving goal-directed haemodynamic therapy (GDHT), LPV and electroencephalographic DAM on postoperative morbidity and mortality. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1-year postoperative autonomy and mortality.
This prospective, randomised, controlled, multicentre trial using a stepped wedge cluster design will be conducted in 27 French university centres. Patients aged 75 years and over, undergoing femoral head fractures and major intraperitoneal or vascular elective surgeries will be included after informed consent. They will benefit from usual care in the 'control group' and from a combined optimisation of general anaesthesia involving GDHT, LPV and DAM in the 'optimisation group'. The cluster's crossover will be unidirectional, from control to optimisation, and randomised. Data will be recorded at inclusion, the day of surgery, 7 days, 30 days and 1year postoperatively and collected into a hosted electronic case report form. The primary outcome of the study is a composite criterion associating major postoperative complications and mortality occurring within the 30 first postoperative days. The secondary outcomes are 1- year postoperative autonomy and mortality.
This protocol was approved by the ethics committee Sud-Est 1 and the French regulatory agency. The finding of the trial will be disseminated through peer-reviewed journals and conferences TRIAL REGISTRATION NUMBER: NCT02668250; Pre-results.
老年患者构成了高危手术群体中越来越大的比例。在成年患者中，几种特定的术中方法，如心输出量导向的血流动力学治疗、麻醉深度监测（DAM）或肺保护性通气（LPV），旨在降低术后死亡率和手术并发症。然而，这些方法都没有专门针对老年人进行，也没有对老年人全身麻醉的多模式优化策略进行评估。
本研究旨在评估 75 岁及以上高危手术患者中，目标导向血流动力学治疗（GDHT）、LPV 和脑电图 DAM 联合优化麻醉对术后发病率和死亡率的影响。研究的主要结果是一个综合标准，将术后 30 天内发生的主要术后并发症和死亡率联系起来。次要结果是 1 年术后自主和死亡率。
这是一项前瞻性、随机、对照、多中心试验，采用阶梯楔形集群设计，将在 27 个法国大学中心进行。入选患者为年龄 75 岁及以上、行股骨头骨折和主要腹腔或血管择期手术的患者，在知情同意后纳入。他们将在对照组中接受常规治疗，在优化组中接受包括 GDHT、LPV 和 DAM 的全身麻醉联合优化。群集的交叉将是单向的，从对照到优化，并且是随机的。数据将在纳入时、手术当天、7 天、30 天和 1 年后记录，并收集到托管电子病例报告表中。研究的主要结果是一个综合标准，将术后 30 天内发生的主要术后并发症和死亡率联系起来。次要结果是 1 年术后自主和死亡率。
本方案已获得 Sud-Est 1 伦理委员会和法国监管机构的批准。试验结果将通过同行评议的期刊和会议进行传播。
NCT02668250；预结果。
