Safety and feasibility of intraoperative high PEEP titrated to the lowest driving pressure during anesthesia for minimally invasive abdominal surgery – Interim analysis of GENERATOR

IF 5.1 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2025-09-30 DOI:10.1016/j.jclinane.2025.112014

Tom D. Vermeulen , Galina Dorland , Liselotte Hol , Sunny Nijbroek , Ary Serpa Neto , Arthur R.A. Bouwman , Chiara Robba , Denise Battaglini , Francesca Rubulotta , Guido Mazzinari , Idit Matot , John G. Laffey , Joseph S.H.A. Koopman , Lorenzo Ball , Lukas Gasteiger , Patrick Schober , Markus W. Hollmann , Marcus J. Schultz , Sabrine N.T. Hemmes , David M.P. van Meenen , Wouter Bos

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引用次数: 0

Abstract

Background

The optimal level of positive end–expiratory pressure (PEEP) during minimally invasive abdominal surgery is uncertain. Intraoperative ventilation with individualized high PEEP and recruitment maneuvers can be used to keep the driving pressure (ΔP) low, but can also lead to hypotension. In addition, the resulting ΔP and feasibility of individualized high PEEP in minimally invasive abdominal surgery is unclear.

Methods

Planned interim analysis on safety and feasibility of ‘Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery’ (GENERATOR), an ongoing randomized clinical trial that compares individualized high PEEP, titrated to the lowest ΔP, with a standard low PEEP ventilation strategy with respect to postoperative pulmonary complications. The primary endpoint for this analysis was the proportion of patients with intraoperative hypotension. Secondary endpoints were other intraoperative complications, ventilation variables and feasibility parameters.

Results

From December 2023 to July 2024, 181 patients were enrolled. Data for analysis were available for 177 patients, of which 87 patients were randomized to individualized high PEEP and 90 to standard low PEEP. Intraoperative hypotension was similar between the individualized high PEEP vs standard low PEEP group (11.5 vs 11.1 %, relative risk ratio 1.0 [95 % CI 0.5–2.4], p = 1.00), while vasopressor use was higher in the intervention group. The median difference in ΔP between both groups was 6 cm H₂O. Protocol compliance was 81.6 % in the individualized high PEEP group vs 97.8 % in the standard low PEEP group; most instances of non–compliance in the individualized high PEEP group concerned a level of PEEP that was too high.

Discussion

In minimally invasive abdominal surgery, a ventilation strategy using individualized high PEEP was not associated with a higher incidence of hypotension, but did show an increased use of vasopressors. The intervention was highly feasible, and led to a lower ΔP. These interim findings warrant confirmation in the main analysis of GENERATOR.

Funding

This research was funded by ZonMW, grant number 10390012110091.

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微创腹部手术麻醉过程中高PEEP滴定至最低驱动压的安全性和可行性——GENERATOR的中期分析。

背景：微创腹部手术中呼气末正压（PEEP）的最佳水平是不确定的。术中通气个体化高PEEP和复吸操作可用于保持低驱动压（ΔP），但也可能导致低血压。此外，在腹部微创手术中个体化高PEEP的结果ΔP和可行性尚不清楚。方法：计划中期分析“微创腹部手术全麻期间驱动压力”（GENERATOR）的安全性和可行性，这是一项正在进行的随机临床试验，比较个体化高PEEP（滴定至最低ΔP）与标准低PEEP通气策略对术后肺部并发症的影响。该分析的主要终点是术中低血压患者的比例。次要终点为其他术中并发症、通气变量和可行性参数。结果：2023年12月至2024年7月，共纳入181例患者。177例患者可获得分析数据，其中87例患者随机分为个体化高PEEP组，90例患者随机分为标准低PEEP组。个体化高PEEP组与标准低PEEP组术中低血压相似（11.5% vs 11.1%，相对风险比1.0 [95% CI 0.5-2.4], p = 1.00），而干预组血管加压药物的使用更高。两组间ΔP的中位差为6 cm H2O。方案依从性个体化高PEEP组为81.6%，标准低PEEP组为97.8%；在个体化的高PEEP组中，大多数不符合的情况都与PEEP水平过高有关。讨论：在微创腹部手术中，使用个体化高PEEP的通气策略与低血压的高发生率无关，但确实显示出血管加压药的使用增加。干预是高度可行的，并导致较低的ΔP。这些临时发现在GENERATOR的主要分析中得到了证实。资助：本研究由ZonMW资助，批准号10390012110091。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.