Menu
Recruiting NCT06101511

Driving Pressure During General Anesthesia for Minimally Invasive Abdominal Surgery (GENERATOR)

No phase Interventional Postoperative Complications Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs.
Who it may be relevant to
Registry conditions: Postoperative Complications, Surgery. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The purpose of this international multicenter, patient and outcome-assessor blinded randomized controlled trial is to determine whether the application of an individualized high Positive End Expiratory Pressure (PEEP) strategy with recruitment maneuvers, aiming at avoiding an increase in the driving pressure during intraoperative ventilation, protects against the development of postoperative pulmonary complications in patients undergoing minimally invasive abdominal surgery.

Interventions

  • Procedure Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs
    The intervention is intraoperative ventilation using the available ventilator with individualized high PEEP titrated to the lowest ΔP with RMs. After abdominal insufflation, patients randomized to the individualized high PEEP with RMs group will receive a RM followed by a 'decremental PEEP trial'. This is followed by a second RM after which PEEP is set at the level indicated by the decremental PEEP trial

Primary outcome measures

  • Proportion of participants developing one or more postoperative pulmonary complications (PPCs) [Time frame: The first 5 postoperative days]
Secondary outcome measures (9)
  • Intraoperative complications [Time frame: For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours]
  • Intraoperative fluid strategy [Time frame: During general anesthesia]
  • Impaired wound healing [Time frame: The first 5 postoperative days]
  • Postoperative extrapulmonary complications [Time frame: The first 5 postoperative days]
  • Mortality [Time frame: Postoperative day 5, day 30 and day 90]
  • Length of stay [Time frame: Postoperatively until the end of the 90 day follow-up period]
  • Oxygen use [Time frame: The first 5 postoperative days]
  • Antibiotics use [Time frame: The first 5 postoperative days]
  • Thoracic imaging [Time frame: The first 5 postoperative days]

Eligibility criteria

Inclusion criteria

  • age > 18 years; AND
  • scheduled for minimally invasive abdominal surgery; AND
  • at increased (i.e., intermediate or high) risk of PPCs according to the 'Assess Respiratory risk in Surgical Patients in Catalonia' (ARISCAT) risk score (≥ 26 points, see Appendix I); OR at increased risk of PPCs based on the combination of age > 40 years, scheduled surgery lasting > 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery; AND
  • signed written informed consent

Exclusion criteria

  • planned for open abdominal surgery;
  • planned for surgery in lateral or prone position;
  • planned for combined abdominal and intra-thoracic surgery
  • confirmed pregnancy;
  • consent for another interventional trial during anesthesia;
  • having received invasive ventilation > 30 minutes within the last five days;
  • any previous lung surgery;
  • history of previous severe chronic obstructive pulmonary disease (COPD) with (noninvasive) ventilation or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD;
  • history of acute respiratory distress syndrome (ARDS);
  • expected to require postoperative ventilation;
  • expected hemodynamic instability or intractable shock;
  • severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmia's).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Amsterdam University Medical Center — Amsterdam

Publications

  • GENERATOR-investigators. Driving pressure during general anesthesia for minimally invasive abdominal surgery (GENERATOR)-study protocol of a randomized clinical trial. Trials. 2024 Oct 26;25(1):719. doi: 10.1186/s13063-024-08479-x. PMID 39456048

Identifiers

NCT: NCT06101511 · NL82971.018.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗