体外循环期间机械通气的不同策略（CPBVENT 2014）：一项随机对照试验的研究方案
Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial.
作者信息
Bignami Elena, Guarnieri Marcello, Saglietti Francesco, Maglioni Enivarco Massimo, Scolletta Sabino, Romagnoli Stefano, De Paulis Stefano, Paternoster Gianluca, Trumello Cinzia, Meroni Roberta, Scognamiglio Antonio, Budillon Alessandro Maria, Pota Vincenzo, Zangrillo Alberto, Alfieri Ottavio
机构信息
Department of Anaesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.
Department of Anaesthesia, Intensive Care and Medical Biotechnologies University of Siena, Siena, Italy.
出版信息
Trials. 2017 Jun 7;18(1):264. doi: 10.1186/s13063-017-2008-2.
BACKGROUND
There is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications.
METHODS/DESIGN: The CPBVENT study is a single-blind, multicenter, randomized controlled trial. We are going to enroll 870 patients undergoing elective cardiac surgery with planned use of cardiopulmonary bypass. Patients will be randomized into three groups: (1) no mechanical ventilation during cardiopulmonary bypass, (2) continuous positive airway pressure of 5 cmHO during cardiopulmonary bypass, (3) respiratory rate of 5 acts/min with a tidal volume of 2-3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3-5 cmHO during cardiopulmonary bypass. The primary endpoint will be the incidence of a PaO/FiO ratio <200 until the time of discharge from the intensive care unit. The secondary endpoints will be the incidence of postoperative pulmonary complications and 30-day mortality. Patients will be followed-up for 12 months after the date of randomization.
DISCUSSION
The CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02090205 . Registered on 8 March 2014.
背景
对于心脏手术患者应采用哪种肺保护策略尚无共识。稀疏且规模较小的随机临床试验和动物试验表明，在体外循环期间维持机械通气对肺部具有保护作用。不幸的是，此类证据较为薄弱，因为它主要来自替代指标和次要临床终点，且主要局限于择期冠状动脉手术。根据学术文献中的现有数据，无法推荐一种无可争议的体外循环期间肺保护标准化策略。CPBVENT研究的目的是调查体外循环期间不同机械通气策略对术后肺功能和并发症的有效性。
方法/设计：CPBVENT研究是一项单盲、多中心、随机对照试验。我们将招募870例计划使用体外循环进行择期心脏手术的患者。患者将被随机分为三组：（1）体外循环期间不进行机械通气；（2）体外循环期间持续气道正压为5 cmH₂O；（3）体外循环期间呼吸频率为5次/分钟，潮气量为理想体重的2 - 3 ml/kg，呼气末正压为3 - 5 cmH₂O。主要终点将是在重症监护病房出院前动脉血氧分压/吸入氧分数值（PaO₂/FiO₂）<200的发生率。次要终点将是术后肺部并发症的发生率和30天死亡率。患者将在随机分组日期后随访12个月。
讨论
CPBVENT试验将确定体外循环期间不同的通气策略是否以及如何对心脏手术患者的术后肺部并发症和结局产生影响。
试验注册
ClinicalTrials.gov，标识符：NCT02090205。于2014年3月8日注册。
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