一项关于高吸入氧分数与传统吸入氧分数的个体化围手术期肺通气策略（iPROVE-O2）及其对手术部位感染影响的原理与研究设计：一项随机对照试验的研究方案
Rationale and study design for an individualised perioperative open-lung ventilatory strategy with a high versus conventional inspiratory oxygen fraction (iPROVE-O2) and its effects on surgical site infection: study protocol for a randomised controlled trial.
作者信息
Ferrando Carlos, Soro Marina, Unzueta Carmen, Canet Jaume, Tusman Gerardo, Suarez-Sipmann Fernando, Librero Julian, Peiró Salvador, Pozo Natividad, Delgado Carlos, Ibáñez Maite, Aldecoa César, Garutti Ignacio, Pestaña David, Rodríguez Aurelio, García Del Valle Santiago, Diaz-Cambronero Oscar, Balust Jaume, Redondo Francisco Javier, De La Matta Manuel, Gallego Lucía, Granell Manuel, Martínez Pascual, Pérez Ana, Leal Sonsoles, Alday Kike, García Pablo, Monedero Pablo, Gonzalez Rafael, Mazzinari Guido, Aguilar Gerardo, Villar Jesús, Belda Francisco Javier
机构信息
Department of Anesthesiology and Critical Care, Hospital Clínico Universitario, Valencia, Spain.
Department of Anesthesiology and Critical Care, Hospital de la Santa Creu i Sant Pau, Valencia, Spain.
出版信息
BMJ Open. 2017 Jul 31;7(7):e016765. doi: 10.1136/bmjopen-2017-016765.
INTRODUCTION
Surgical site infection (SSI) is a serious postoperative complication that increases morbidity and healthcare costs. SSIs tend to increase as the partial pressure of tissue oxygen decreases: previous trials have focused on trying to reduce them by comparing high versus conventional inspiratory oxygen fractions (FIO) in the perioperative period but did not use a protocolised ventilatory strategy. The open-lung ventilatory approach restores functional lung volume and improves gas exchange, and therefore it may increase the partial pressure of tissue oxygen for a given FIO. The trial presented here aims to compare the efficacy of high versus conventional FIO in reducing the overall incidence of SSIs in patients by implementing a protocolised and individualised global approach to perioperative open-lung ventilation.
METHODS AND ANALYSIS
This is a comparative, prospective, multicentre, randomised and controlled two-arm trial that will include 756 patients scheduled for abdominal surgery. The patients will be randomised into two groups: (1) a high FIO group (80% oxygen; FIO of 0.80) and (2) a conventional FIO group (30% oxygen; FIO of 0.30). Each group will be assessed intra- and postoperatively. The primary outcome is the appearance of postoperative SSI complications. Secondary outcomes are the appearance of systemic and pulmonary complications.
ETHICS AND DISSEMINATION
The iPROVE-O2 trial has been approved by the Ethics Review Board at the reference centre (the Hospital Clínico Universitario in Valencia). Informed consent will be obtained from all patients before their participation. If the approach using high FIO during individualised open-lung ventilation decreases SSIs, use of this method will become standard practice for patients scheduled for future abdominal surgery. Publication of the results is anticipated in early 2019.
TRIAL REGISTRATION NUMBER
NCT02776046; Pre-results.
引言
手术部位感染（SSI）是一种严重的术后并发症，会增加发病率和医疗成本。随着组织氧分压降低，SSI的发生率往往会增加：以往的试验主要集中在围手术期通过比较高吸入氧分数（FIO）与传统吸入氧分数来试图降低SSI，但未采用标准化的通气策略。肺开放通气方法可恢复功能性肺容积并改善气体交换，因此对于给定的FIO，它可能会增加组织氧分压。本文介绍的试验旨在通过实施标准化和个体化的围手术期肺开放通气整体方法，比较高FIO与传统FIO在降低患者SSI总体发生率方面的疗效。
方法与分析
这是一项比较性、前瞻性、多中心、随机对照双臂试验，将纳入756例计划接受腹部手术的患者。患者将被随机分为两组：（1）高FIO组（80%氧气；FIO为0.80）和（2）传统FIO组（30%氧气；FIO为0.30）。每组将在术中和术后进行评估。主要结局是术后SSI并发症的出现。次要结局是全身和肺部并发症的出现。
伦理与传播
iPROVE - O2试验已获得参考中心（巴伦西亚大学临床医院）伦理审查委员会的批准。所有患者在参与前将获得知情同意。如果在个体化肺开放通气期间使用高FIO的方法能降低SSI，那么该方法将成为未来计划接受腹部手术患者的标准做法。预计2019年初公布结果。
试验注册号
NCT0277604；预结果。
Zotero 插件