Smit-Fun Valérie M, de Korte-de Boer Dianne, Posthuma Linda M, Stolze Annick, Dirksen Carmen D, Hollmann Markus W, Buhre Wolfgang F, Boer Christa
Department of Anaesthesiology & Pain Medicine, Maastricht University Medical Centre +, P. Debeyelaan 25, 6229 HX, Maastricht, The Netherlands.
Department of Anaesthesiology, Academic Medical Centre Amsterdam, Meibergdreef 9 H1Z-132, 1105 AZ, Amsterdam, The Netherlands.
Trials. 2018 Oct 26;19(1):586. doi: 10.1186/s13063-018-2952-5.
Perioperative complications occur in 30-40% of non-cardiac surgical patients and are the leading cause of early postoperative morbidity and mortality. Regular visits by trained health professionals may decrease the incidence of complications and mortality through earlier detection and adequate treatment of complications. Until now, no studies have been performed on the impact of routine postsurgical anesthesia visits on the incidence of postoperative complications and mortality.
TRACE is a prospective, multicenter, stepped-wedge cluster randomized interventional study in academic and peripheral hospitals in the Netherlands. All hospitals start simultaneously with a control phase in which standard care is provided. Sequentially, in a randomized order, hospitals cross over to the intervention phase in which patients at risk are routinely followed up by an anesthesia professional at postoperative days 1 and 3, aiming to detect and prevent or treat postoperative complications. We aim to include 5600 adult patients who are at high risk of developing complications. The primary outcome variable is 30-day postoperative mortality. Secondary outcomes include incidence of postoperative complications and postoperative quality of life up to one year following surgery. Statistical analyses will be performed to compare the control and intervention cohorts with multilevel linear and logistic regression models, adjusted for temporal trends and for clusters (hospitals). The time horizon of the economic (cost-effectiveness) evaluation will be 30 days and one year following surgery.
TRACE is the first to study the effects of a routine postoperative visit by an anesthesia healthcare professional on mortality and cost-effectiveness of surgical patients. If the intervention proves to be beneficial for the patient and cost-effective, the stepped-wedge design ensures direct implementation in the participating hospitals.
Nederlands Trial Register/Netherlands Trial Registration, NTR5506 . Registered on 02 December 2015.
30%-40%的非心脏手术患者会出现围手术期并发症，这是术后早期发病和死亡的主要原因。训练有素的卫生专业人员定期查房，可通过更早发现并发症并进行适当治疗，降低并发症和死亡率。迄今为止，尚未有关于术后常规麻醉查房对术后并发症发生率和死亡率影响的研究。
TRACE是一项在荷兰学术医院和周边医院开展的前瞻性、多中心、阶梯式楔形整群随机干预研究。所有医院同时开始对照阶段，提供标准护理。随后，各医院按随机顺序进入干预阶段，在此阶段，麻醉专业人员会在术后第1天和第3天对有风险的患者进行常规随访，旨在检测和预防或治疗术后并发症。我们的目标是纳入5600名有发生并发症高风险的成年患者。主要结局变量是术后30天死亡率。次要结局包括术后并发症发生率以及术后长达一年的生活质量。将进行统计分析，使用多水平线性和逻辑回归模型比较对照队列和干预队列，并对时间趋势和整群（医院）进行调整。经济（成本效益）评估的时间范围为术后30天和一年。
TRACE是首个研究麻醉医护人员术后常规查房对手术患者死亡率和成本效益影响的研究。如果该干预措施被证明对患者有益且具有成本效益，阶梯式楔形设计可确保在参与研究的医院直接实施。
荷兰试验注册中心，NTR5506。于2015年12月2日注册。
