成人心脏手术体外循环期间采用低潮气量和呼气末正压通气与不进行通气的效果比较：一项随机临床试验
Maintaining ventilation with very low tidal volume and positive-end expiratory pressure versus no ventilation during cardiopulmonary bypass for cardiac surgery in adults: a randomized clinical trial.
作者信息
Tadié Jean-Marc, Ouattara Alexandre, Laviolle Bruno, Lesouhaitier Mathieu, Esvan Maxime, Rousseau Chloé, Grégoire Murielle, Gaudriot Baptiste, Nesseler Nicolas, Labaste François, Sanchez Pascale, Marcheix Bertrand, Beurton Antoine, Dureau Pauline, Demondion Pierre, Fouquet Olivier, Rineau Emmanuel, Amour Julien, Verhoye Jean-Philippe, Mercat Alain, Terzi Nicolas, Tarte Karin, Bouglé Adrien, Flecher Erwan
机构信息
Department of Infectious Diseases and Intensive Care Unit, Centre Hospitalier Universitaire Rennes, Université de Rennes 1, Rennes, France.
SITI Laboratory, UMR U1236, INSERM, University of Rennes, EFS, Rennes University Hospital, Rennes, France.
出版信息
Intensive Care Med. 2025 May 5. doi: 10.1007/s00134-025-07901-5.
PURPOSE
Cardiopulmonary bypass (CPB) during cardiac surgery mechanically circulates and oxygenates the blood, bypassing the heart and lungs. Despite limited evidence, maintaining mechanical ventilation (MV) during CPB is recommended, as ventilator strategies during surgery may reduce the occurrence of postoperative infections. We aimed to determine whether maintaining MV for cardiac surgery would decrease postoperative infections compared with stopping MV during CPB.
METHODS
We conducted a multicenter, single-blind, randomized trial among adult patients undergoing scheduled cardiac surgery with CPB in six hospitals in France. During CPB, the tracheal tube was disconnected from the ventilator in the control group (MV- group). In the MV + group, ventilation was maintained during CPB with very low tidal volume ventilation, using a tidal volume of 2.5 mL/kg of predicted body weight, with 5-7 cmHO positive end expiratory pressure. The primary outcome was the occurrence of all types of postoperative infections within the first 28 days after surgery. There were six secondary evaluation criteria including the number of days of exposure to antibiotics.
RESULTS
A total of 1362 patients were enrolled in the study. Postoperative infection occurred in 74 out of 680 patients (10.9%) in the MV- group, compared to 68 out of 682 patients (10.0%) in the MV + group (relative risk, 0.92; 95% confidence interval [CI] 0.67-1.25; p = 0.58). Antibiotic use was higher in the MV + group than in the MV- group (incidence risk ratio, 1.08; 95% CI 1.02-1.15; p = 0.02). There were no significant differences between the groups for all other secondary outcomes or for the incidence of adverse events.
CONCLUSIONS
Maintaining very low tidal volume ventilation with positive end-expiratory pressure during CPB did not reduce postoperative infections at 28 days compared to when mechanical ventilation was stopped during CPB. An unexpectedly higher use of antibiotics was observed when ventilation was maintained.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03372174).
目的
心脏手术期间的体外循环（CPB）通过机械方式使血液循环并进行氧合，绕过心脏和肺部。尽管证据有限，但仍建议在CPB期间维持机械通气（MV），因为手术期间的通气策略可能会减少术后感染的发生。我们旨在确定与CPB期间停止MV相比，心脏手术中维持MV是否会减少术后感染。
方法
我们在法国六家医院对接受计划性心脏手术并使用CPB的成年患者进行了一项多中心、单盲、随机试验。在CPB期间，对照组（MV-组）将气管导管与呼吸机断开。在MV +组中，CPB期间通过使用2.5 mL/kg预计体重的潮气量进行极低潮气量通气，并维持5-7 cmH₂O呼气末正压来维持通气。主要结局是术后28天内所有类型术后感染的发生情况。有六个次要评估标准，包括抗生素暴露天数。
结果
共有1362例患者纳入研究。MV-组680例患者中有74例（10.9%）发生术后感染，MV +组682例患者中有68例（10.0%）发生术后感染（相对风险，0.92；95%置信区间[CI] 0.67-1.25；p = 0.58）。MV +组的抗生素使用高于MV-组（发病风险比，1.08；95% CI 1.02-1.15；p = 0.02）。在所有其他次要结局或不良事件发生率方面，两组之间无显著差异。
结论
与CPB期间停止机械通气相比，CPB期间维持极低潮气量通气并加用呼气末正压在28天时并未减少术后感染。维持通气时观察到抗生素使用意外增加。
试验注册
ClinicalTrials.gov（NCT03372174）。
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