William Harvey Research Institute, Queen Mary University of London, London, UK -
William Harvey Research Institute, Queen Mary University of London, London, UK.
Minerva Anestesiol. 2017 Feb;83(2):175-182. doi: 10.23736/S0375-9393.16.11502-0. Epub 2016 Oct 20.
Over 300 million patients undergo surgery worldwide each year. Postoperative morbidity - particularly respiratory complications - are most frequent and severe among high-risk patients undergoing major abdominal surgery. However, standard treatments, like physiotherapy or supplemental oxygen, often fail to prevent these. Preliminary research suggests that prophylactic continuous positive airways pressure (CPAP) can reduce the risk of postoperative respiratory complications. However, without evidence from a large clinical effectiveness trial, CPAP has not become routine care. This trial aims to determine whether early postoperative CPAP reduces the incidence of respiratory complications and improves one-year survival following major intra-peritoneal surgery.
This is an international multicenter randomized controlled trial with open study group allocation. The participants are aged 50 years and over undergoing major elective intra-peritoneal surgery. The intervention is CPAP for at least four hours, started within four hours of the end of surgery.
The primary outcome is a composite of pneumonia, re-intubation, or death within 30 days of randomization. All participants with a recorded outcome will be analyzed on an intention-to-treat basis. The primary analysis will use a mixed-effects logistic regression model, which includes center as a random-intercept, and will be adjusted for the minimization factors and other pre-specified covariates. Trial Registration: ISRCTN 56012545.
This is the first proposed clinical effectiveness trial of postoperative CPAP to prevent respiratory complications of which we are aware. The large sample size and multicenter international design will make the result generalizable to a variety of healthcare settings.
全球每年有超过 3 亿患者接受手术。术后发病率 - 尤其是呼吸系统并发症 - 在接受大腹部手术的高危患者中最为常见和严重。然而，标准治疗方法，如物理疗法或补充氧气，往往无法预防这些并发症。初步研究表明，预防性持续气道正压通气（CPAP）可以降低术后呼吸系统并发症的风险。然而，由于缺乏大型临床疗效试验的证据，CPAP 尚未成为常规治疗。本试验旨在确定术后早期 CPAP 是否可以降低大腹腔手术后呼吸系统并发症的发生率并提高一年生存率。
这是一项国际多中心随机对照试验，采用开放组分配研究方法。参与者年龄在 50 岁及以上，接受大择期腹腔内手术。干预措施是 CPAP 治疗至少 4 小时，在手术结束后 4 小时内开始。
主要结局是随机分组后 30 天内肺炎、重新插管或死亡的复合事件。所有有记录结局的参与者都将基于意向治疗进行分析。主要分析将使用混合效应逻辑回归模型，该模型包括中心作为随机截距，并将根据最小化因素和其他预设协变量进行调整。试验注册：ISRCTN56012545。
这是我们所知的第一个关于术后 CPAP 预防呼吸系统并发症的临床有效性试验。大样本量和多中心国际设计将使结果能够推广到各种医疗保健环境中。
