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首页> 外文期刊>Trials >Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial
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Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial

机译：低潮气量机械通气，在体外循环心脏手术（MECANO）期间不进行通气：一项随机对照试验的研究方案

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Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. There are no recommendations on mechanical ventilation associated with cardiopulmonary bypass (CPB) during surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain low tidal volume (LTV) ventilation. Indirect evidence points towards better pulmonary outcomes when LTV is performed but no large-scale prospective trial has yet been published in cardiac surgery. The MECANO trial is a single-center, double-blind, randomized, controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. In total, 1500 patients are expected to be included, without any restrictions. They will be randomized between noV and LTV on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 breaths/minute with a tidal volume of 3?mL/kg and positive end-expiratory pressure of 5 cmH2O. The primary endpoint will be a composite of all-cause mortality, early respiratory failure defined as a ratio of partial pressure of oxygen/fraction of inspired oxygen <200?mmHg at 1?hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high-flow oxygen) at 2?days after arrival in the ICU or ventilator-acquired pneumonia defined by the Center of Disease Control. Lung recruitment maneuvers will be performed in the noV and LTV groups at the end of surgery and at arrival in ICU with an insufflation at +30 cmH20 for 5?seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cell transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. The MECANO trial is the first of its kind to compare in a double-blind design, a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, with a primary composite outcome including death, respiratory failure and postoperative pneumonia. ClinicalTrials.gov, NCT03098524 . Registered on 27 February 2017.
机译：术后肺部并发症是心脏手术后发病和死亡的主要原因。对于手术过程中与体外循环（CPB）相关的机械通气没有建议，麻醉医生在CPB期间完全不通气（noV）或维持低潮气量（LTV）通气。间接证据表明，进行LTV时可改善肺结局，但心脏手术尚无大规模的前瞻性试验发表。 MECANO试验是一项单中心，双盲，随机，对照试验，比较了CPB心脏手术期间两种机械通气策略（noV和LTV）。预计将总共包括1500名患者，而没有任何限制。它们将以1：1的比例在noV和LTV之间随机分配。在CPB期间，noV组将不进行任何通气。 LTV组将接受5次呼吸/分钟，潮气量为3？mL / kg，呼气末正压为5 cmH2O。主要终点将是全因死亡率，早期呼吸衰竭的复合物，早期呼吸衰竭的定义为氧分压/到达ICU 1小时后吸入的氧分率<200？mmHg的比例，重度氧合支持（定义为在到达ICU或疾病控制中心定义的呼吸机获得性肺炎后2天，需要无创通气，机械通气或高流量氧气的患者。在手术结束时和到达ICU时，将在noV和LTV组中进行肺募集演习，并在+30 cmH2O处吹气5秒钟。次要终点是那些主要终点加上气胸，CPB持续时间，术后出血量，红细胞输血，翻修手术要求，在ICU和医院的住院时间以及总住院费用的终点。患者将被随访直至出院。 MECANO试验是首例在双盲设计中进行比较的试验，该试验是CPB心脏手术中机械通气的无通气量与低潮气量策略的比较，主要复合结果包括死亡，呼吸衰竭和术后肺炎。 ClinicalTrials.gov，NCT03098524。 2017年2月27日注册。

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