肥胖患者术中采用较高与较低呼气末正压水平进行保护性通气（PROBESE）：一项随机对照试验的研究方案
Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.
作者信息
Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes S N, Hiesmayr M, Hollmann M W, Jaber S, Laffey J G, Licker M J, Markstaller K, Matot I, Müller G, Mills G H, Mulier J P, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo M F, Wrigge H, Schultz M J, Pelosi P, Gama de Abreu M
机构信息
Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Dresden, Germany.
Aneszteziológiai és Intenzív Terápiás Klinika, Semmelweis Egyetem, Budapest, Hungary.
出版信息
Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.
BACKGROUND
Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients.
METHODS/DESIGN: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmHO with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmHO without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint.
DISCUSSION
To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
背景
术后肺部并发症（PPCs）会增加肥胖患者手术的发病率和死亡率。高水平呼气末正压（PEEP）联合肺复张手法可能会改善术中呼吸功能，但也可能影响血流动力学，且对PPCs的影响尚不确定。我们假设，与不进行肺复张手法的低PEEP相比，术中使用高PEEP并定期进行肺复张手法的机械通气可预防肥胖患者发生PPCs。
方法/设计：肥胖患者全麻手术中高PEEP与低PEEP的保护性通气（PROBESE）研究是一项多中心、双臂、国际随机对照试验。总共将纳入2013例体重指数≥35kg/m²、计划接受至少2小时全麻手术且发生PPCs的中高风险肥胖患者。术中患者采用7ml/kg（预测体重）的低潮气量通气，并随机分为接受肺复张手法的12cmH₂O PEEP（高PEEP）组或不进行肺复张手法的4cmH₂O PEEP（低PEEP）组。PPCs的发生将记录为单一不良肺部事件的综合指标，作为主要终点。
讨论
据我们所知，PROBESE试验是第一项比较两种不同水平的术中PEEP在保护性低潮气量通气时对肥胖患者PPCs影响的多中心、国际随机对照试验。PROBESE试验的结果将有助于麻醉医生在为肥胖患者进行全麻手术时选择特定PEEP水平，以预防PPCs。
试验注册
ClinicalTrials.gov标识符：NCT02148692。于2014年5月23日注册；最后更新于2016年6月7日。
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