在急诊腹部开腹手术/扫描中采用个体化 PeriopeRative 开肺通气法的理由和研究设计:前瞻性国际随机对照试验的研究方案。

G. Laguna , F. Suárez-Sipmann , G. Tusman , J. Ripollés , O. Díaz-Cambronero , R. Pujol , E. Rivas , I. Garutti , R. Mellado , J. Vallverdú , A. Jacas , A. Fervienza , R. Marrero , J. Librero , J. Villar , C. Ferrando
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引用次数: 0

摘要

背景术后肺部并发症(PPC)是最常见的术后并发症,在择期手术中的发病率估计从观察性队列研究的 20% 到随机临床试验的 40% 不等。然而,急诊腹部手术患者的 PPC 发生率尚不明确。肺保护性通气旨在将呼吸机诱发的肺损伤降至最低并减少 PPCs。开肺通气法(OLA)结合了募集动作(RM)和呼气末正压(PEEP)滴定,旨在最大限度地减少无肺活量区域和 PPCs 的发生;然而,文献中并没有确凿的证据表明开肺通气法可以预防 PPCs。本研究旨在对有术中肺塌陷临床表现的急诊腹部手术患者进行个体化围手术期 OLA 与常规标准化肺保护通气的比较。患者将被随机分为开放标签平行组。主要结果是术后前 7 天内出现任何严重的 PPC,包括:急性呼吸衰竭、气胸、断奶失败、急性呼吸窘迫综合征和肺部感染。预计样本量为 732 例患者(每组 366 例)。讨论急诊腹部开腹手术中的个体化围手术期开肺通气策略(iPROVE-EAL)是首个研究个体化围手术期方法是否能预防急诊手术患者发生 PPC 的多中心随机对照试验。
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Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial

Background

Postoperative pulmonary complications (PPC) are the most frequent postoperative complications, with an estimated prevalence in elective surgery ranging from 20% in observational cohort studies to 40% in randomized clinical trials. However, the prevalence of PPCs in patients undergoing emergency abdominal surgery is not well defined. Lung-protective ventilation aims to minimize ventilator-induced lung injury and reduce PPCs. The open lung approach (OLA), which combines recruitment manoeuvres (RM) and positive end-expiratory pressure (PEEP) titration, aims to minimize areas of atelectasis and the development of PPCs; however, there is no conclusive evidence in the literature that OLA can prevent PPCs. The purpose of this study is to compare an individualized perioperative OLA with conventional standardized lung-protective ventilation in patients undergoing emergency abdominal surgery with clinical signs of intraoperative lung collapse.

Methods

Randomized international clinical trial to compare an individualized perioperative OLA (RM plus individualized PEEP and individualized postoperative respiratory support) with conventional lung-protective ventilation (standard PEEP of 5 cmH2O and conventional postoperative oxygen therapy) in patients undergoing emergency abdominal surgery with clinical signs of lung collapse. Patients will be randomised to open-label parallel groups. The primary outcome is any severe PPC during the first 7 postoperative days, including: acute respiratory failure, pneumothorax, weaning failure, acute respiratory distress syndrome, and pulmonary infection. The estimated sample size is 732 patients (366 per group). The final sample size will be readjusted during the interim analysis.

Discussion

The Individualized Perioperative Open-lung Ventilatory Strategy in emergency abdominal laparotomy (iPROVE-EAL) is the first multicentre, randomized, controlled trial to investigate whether an individualized perioperative approach prevents PPCs in patients undergoing emergency surgery.

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