体外循环心脏手术后开放肺与常规围手术期通气策略对术后肺部并发症的影响：PROVECS 随机临床试验。
Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial.
机构信息
Département d'Anesthésie et Réanimation (SAR 2), CHU La Timone, Assistance Publique des Hôpitaux de Marseille, Marseille, France.
C2VN, Inserm 1263, Inra 1260, Aix Marseille Université, Marseille, France.
出版信息
Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.
PURPOSE
To evaluate whether a perioperative open-lung ventilation strategy prevents postoperative pulmonary complications after elective on-pump cardiac surgery.
METHODS
In a pragmatic, randomized, multicenter, controlled trial, we assigned patients planned for on-pump cardiac surgery to either a conventional ventilation strategy with no ventilation during cardiopulmonary bypass (CPB) and lower perioperative positive end-expiratory pressure (PEEP) levels (2 cm HO) or an open-lung ventilation strategy that included maintaining ventilation during CPB along with perioperative recruitment maneuvers and higher PEEP levels (8 cm HO). All study patients were ventilated with low-tidal volumes before and after CPB (6 to 8 ml/kg of predicted body weight). The primary end point was a composite of pulmonary complications occurring within the first 7 postoperative days.
RESULTS
Among 493 randomized patients, 488 completed the study (mean age, 65.7 years; 360 (73.7%) men; 230 (47.1%) underwent isolated valve surgery). Postoperative pulmonary complications occurred in 133 of 243 patients (54.7%) assigned to open-lung ventilation and in 145 of 245 patients (59.2%) assigned to conventional ventilation (p = 0.32). Open-lung ventilation did not significantly reduce the use of high-flow nasal oxygenotherapy (8.6% vs 9.4%; p = 0.77), non-invasive ventilation (13.2% vs 15.5%; p = 0.46) or new invasive mechanical ventilation (0.8% vs 2.4%, p = 0.28). Mean alive ICU-free days at postoperative day 7 was 4.4 ± 1.3 days in the open-lung group vs 4.3 ± 1.3 days in the conventional group (mean difference, 0.1 ± 0.1 day, p = 0.51). Extra-pulmonary complications and adverse events did not significantly differ between groups.
CONCLUSIONS
A perioperative open-lung ventilation including ventilation during CPB does not reduce the incidence of postoperative pulmonary complications as compared with usual care. This finding does not support the use of such a strategy in patients undergoing on-pump cardiac surgery.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier: NCT02866578. https://clinicaltrials.gov/ct2/show/NCT02866578.
目的
评估体外循环期间的开放性肺通气策略是否可预防择期体外循环心脏手术后的肺部并发症。
方法
在一项实用、随机、多中心、对照试验中，我们将计划进行体外循环心脏手术的患者随机分配至常规通气策略（体外循环期间不进行通气，且围手术期呼气末正压（PEEP）水平较低（2 cm H2O））或开放性肺通气策略（包括体外循环期间的通气，以及围手术期的复张手法和较高的 PEEP 水平（8 cm H2O））。所有研究患者在体外循环前后均接受低潮气量通气（6 至 8 ml/kg 预测体重）。主要终点是术后 7 天内发生的肺部并发症的综合指标。
结果
在 493 名随机患者中，488 名完成了研究（平均年龄 65.7 岁；360 名[73.7%]为男性；230 名[47.1%]接受了单纯瓣膜手术）。接受开放性肺通气的 243 名患者中有 133 名（54.7%）和接受常规通气的 245 名患者中有 145 名（59.2%）发生了术后肺部并发症（p=0.32）。开放性肺通气并未显著降低高流量鼻氧疗（8.6% vs 9.4%；p=0.77）、无创通气（13.2% vs 15.5%；p=0.46）或新的有创机械通气（0.8% vs 2.4%，p=0.28）的使用率。在术后第 7 天，开放性肺通气组的存活 ICU 无天数为 4.4±1.3 天，常规通气组为 4.3±1.3 天（平均差异，0.1±0.1 天，p=0.51）。两组间的肺外并发症和不良事件无显著差异。
结论
与常规治疗相比，包括体外循环期间通气的围手术期开放性肺通气策略并不能降低术后肺部并发症的发生率。这一发现不支持在接受体外循环心脏手术的患者中使用这种策略。
试验注册
Clinicaltrials.gov 标识符：NCT02866578。https://clinicaltrials.gov/ct2/show/NCT02866578。
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