High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial.
High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial.
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DOI：
10.1016/s0140-6736(14)60416-5
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发表时间：
2014-08-09
期刊：
影响因子：
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通讯作者：
Schultz MJ
中科院分区：
文献类型：
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作者：
PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology;Hemmes SN;Gama de Abreu M;Pelosi P;Schultz MJ
在手术全麻期间，呼气末正压在机械通气中的作用仍不确定。压力高于0cmH2O可以预防术后肺部并发症，但也可能导致术中循环抑制和过度扩张所致的肺损伤。我们测试了这样一种假设，即高水平的呼气末正压和复张动作可以预防有并发症风险的患者术后肺部并发症的发生，这些患者在开腹手术全麻期间接受低潮气量的机械通气。在这项在欧洲、北美和南美的30个中心进行的随机对照试验中，我们招募了900名有术后肺部并发症风险的患者，他们计划在全麻和潮气量为8毫升/公斤的通气量下进行开腹手术。我们随机将患者分为高呼气末正压(12 Cm H2O)和低呼气末正压(≤2 cm H2O)组(低PEEP组)，其中高呼气末正压(12 Cm H2O)和高呼气末正压(12 Cm H2O)结合PEEP(高PEEP组)。我们使用了一个集中的计算机生成的随机系统。患者和结果评估员被蒙面接受干预。主要终点是术后第5天的肺部并发症的复合体。通过意向治疗进行分析。这项研究在Control-Trials.com上注册，编号为ISRCTN70332574。从2011年2月至2013年1月，447例患者被随机分配到高PEEP组和453例低PEEP组。6名患者被排除在分析之外，4名患者因撤回同意，2名患者违反纳入标准。呼气末正压中位数：高PEEP组为12 cm H2O(IQR 12~12)，低PEEP组为2 cm H2O(0~2)。术后肺部并发症发生率：高PEEP组174例(40%)，低PEEP组172例(39%)(相对危险度1·01；95%可信区间0·86~1·20；P=0·86)。与低PEEP组相比，高PEEP组出现术中低血压，需要更多的血管活性药物。在开腹手术中采用高水平呼气末正压和复张动作的策略并不能预防术后肺部并发症。术中保护性通气策略应包括低潮气量和低呼气末正压，不进行复张动作。欧洲麻醉学学会学术医学中心(荷兰阿姆斯特丹)。
The role of positive end-expiratory pressure in mechanical ventilation during general anaesthesia for surgery remains uncertain. Levels of pressure higher than 0 cm H2O might protect against postoperative pulmonary complications but could also cause intraoperative circulatory depression and lung injury from overdistension. We tested the hypothesis that a high level of positive end-expiratory pressure with recruitment manoeuvres protects against postoperative pulmonary complications in patients at risk of complications who are receiving mechanical ventilation with low tidal volumes during general anaesthesia for open abdominal surgery. In this randomised controlled trial at 30 centres in Europe and North and South America, we recruited 900 patients at risk for postoperative pulmonary complications who were planned for open abdominal surgery under general anaesthesia and ventilation at tidal volumes of 8 mL/kg. We randomly allocated patients to either a high level of positive end-expiratory pressure (12 cm H2O) with recruitment manoeuvres (higher PEEP group) or a low level of pressure (≤2 cm H2O) without recruitment manoeuvres (lower PEEP group). We used a centralised computer- generated randomisation system. Patients and outcome assessors were masked to the intervention. Primary endpoint was a composite of postoperative pulmonary complications by postoperative day 5. Analysis was by intention-to-treat. The study is registered at Controlled-Trials.com, number ISRCTN70332574. From February, 2011, to January, 2013, 447 patients were randomly allocated to the higher PEEP group and 453 to the lower PEEP group. Six patients were excluded from the analysis, four because they withdrew consent and two for violation of inclusion criteria. Median levels of positive end-expiratory pressure were 12 cm H2O (IQR 12–12) in the higher PEEP group and 2 cm H2O (0–2) in the lower PEEP group. Postoperative pulmonary complications were reported in 174 (40%) of 445 patients in the higher PEEP group versus 172 (39%) of 449 patients in the lower PEEP group (relative risk 1·01; 95% CI 0·86–1·20; p=0·86). Compared with patients in the lower PEEP group, those in the higher PEEP group developed intraoperative hypotension and needed more vasoactive drugs. A strategy with a high level of positive end-expiratory pressure and recruitment manoeuvres during open abdominal surgery does not protect against postoperative pulmonary complications. An intraoperative protective ventilation strategy should include a low tidal volume and low positive end-expiratory pressure, without recruitment manoeuvres. Academic Medical Center (Amsterdam, Netherlands), European Society of Anaesthesiology.