Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x.
Intraoperative driving pressure (ΔP) has an independent association with the development of postoperative pulmonary complications (PPCs) in patients receiving ventilation during general anesthesia for major surgery. Ventilation with high intraoperative positive end-expiratory pressure (PEEP) with recruitment maneuvers (RMs) that result in a low ΔP has the potential to prevent PPCs. This trial tests the hypothesis that compared to standard low PEEP without RMs, an individualized high PEEP strategy, titrated to the lowest ΔP, with RMs prevents PPCs in patients receiving intraoperative protective ventilation during anesthesia for minimally invasive abdominal surgery.
"DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery (GENERATOR)" is an international, multicenter, two-group, patient and outcome-assessor blinded randomized clinical trial. In total, 1806 adult patients scheduled for minimally invasive abdominal surgery and with an increased risk of PPCs based on (i) the ARISCAT risk score for PPCs (≥ 26 points) and/or (ii) a combination of age > 40 years and scheduled surgery lasting > 2 h and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery will be included. Patients are assigned to either an intraoperative ventilation strategy with individualized high PEEP, titrated to the lowest ΔP, with RMs or one with a standard low PEEP of 5 cm HO without RMs. The primary outcome is a collapsed composite endpoint of PPCs until postoperative day 5.
GENERATOR will be the first adequately powered randomized clinical trial to compare the effects of individualized high PEEP with RMs versus standard low PEEP without RMs on the occurrence of PPCs after minimally invasive abdominal surgery. The results of the GENERATOR trial will support anesthesiologists in their decisions regarding PEEP settings during minimally invasive abdominal surgery.
GENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023.
在全身麻醉下接受大手术通气的患者中，术中驱动压（ΔP）与术后肺部并发症（PPCs）的发生有独立关联。采用术中高呼气末正压（PEEP）加复张手法（RMs）以降低 ΔP 的通气方式，有预防 PPCs 的潜力。本试验旨在验证如下假说，即在全身麻醉下接受微创手术时采用术中保护性通气的患者中，与标准低 PEEP 加 RMs 相比，采用个体化高 PEEP 策略并滴定至最低 ΔP 加 RMs 可预防 PPCs。
“DrivinG prEssure duriNg gEneRal AnesThesia fOr minimally invasive abdominal suRgery（GENERATOR）”是一项国际性、多中心、两臂、患者和结局评估者双盲随机临床试验。共有 1806 名接受微创手术且基于（i）PPCs 的 ARISCAT 风险评分（≥26 分）和/或（ii）年龄＞40 岁且手术时间＞2 小时和计划在手术期间接受动脉内导管进行血压监测的患者，将被纳入研究。患者被分配至采用个体化高 PEEP、滴定至最低 ΔP 并加 RMs 的术中通气策略或采用标准低 PEEP（5cmH2O）且不加 RMs 的通气策略。主要结局为至术后第 5 天的 PPCs 复合终点。
GENERATOR 将是第一项充分有力的随机临床试验，旨在比较个体化高 PEEP 加 RMs 与标准低 PEEP 不加 RMs 对微创手术后 PPCs 发生率的影响。GENERATOR 试验的结果将支持麻醉医生在微创手术期间设定 PEEP 时的决策。
GENERATOR 于 2023 年 10 月 26 日在 ClinicalTrials.gov 上注册（研究标识符：NCT06101511）。
