Evidence map›Paper›PMID 39456048›Full record

ArticleTrials2024

Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial.

GENERATOR–investigators

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06101511 (Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06101511 narecruitingnot on this map

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR) - a Randomized Clinical Trial

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2023 to 2027Enrolled1,806ConditionsPostoperative Complications, SurgeryArmsIntraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

1 author.

GENERATOR–investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntraoperative 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.

methods"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 H DISCUSSION: 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.

trial registrationGENERATOR is registered at ClinicalTrials.gov (study identifier: NCT06101511) on 26 October 2023.

Indexed as

AbdomenAnesthesia, GeneralMinimally Invasive Surgical ProceduresMulticenter Studies as TopicPositive-Pressure RespirationRandomized Controlled Trials as TopicHumansLung DiseasesPostoperative ComplicationsTime FactorsTreatment OutcomeDriving pressureIntraoperative ventilationMechanical ventilationMinimally invasive abdominal surgeryPositive end − expiratory pressurePostoperative complicationsPostoperative pulmonary complicationsPulmonary complicationsRecruitment maneuver

Identifiers

PMID39456048
PMCPMC11515191

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.