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

NCT06101511 | Recruiting DMC

• 1 other identifier: NL82971.018.23
• Study Type: interventional
• Target: 1,806
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Complications; Surgery

Keywords

Minimally invasive abdominal surgery; Mechanical ventilation; Positive end-expiratory pressure; Driving pressure; Postoperative pulmonary complications; Recruitment maneuver

Outcome Measures

Primary Outcomes (1)

• Proportion of participants developing one or more postoperative pulmonary complications (PPCs)

  A composite of the following pulmonary complications: mild respiratory failure; severe respiratory failure; bronchospasm; suspected pulmonary infection; pulmonary infiltrate; aspiration pneumonitis; atelectasis; acute respiratory distress syndrome (ARDS); pleural effusion; cardiopulmonary edema; pneumothorax

  The first 5 postoperative days

Secondary Outcomes (9)

• Intraoperative complications

  For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours

• Intraoperative fluid strategy

  During general anesthesia

• Impaired wound healing

  The first 5 postoperative days

• Postoperative extrapulmonary complications

  The first 5 postoperative days

• Mortality

  Postoperative day 5, day 30 and day 90

Study Arms (2)

Individualized high PEEP strategy with recruitment maneuvers

EXPERIMENTAL

The intervention is intraoperative ventilation using the available ventilator with individualized high positive end-expiratory pressure (PEEP) titrated to the lowest driving pressure (ΔP) with recruitment maneuvers (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.

Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

Standard low PEEP strategy without recruitment maneuvers

NO INTERVENTION

Patients randomized to the standard low PEEP group will receive 5 cm H2O PEEP for the complete duration of general anesthesia. They will neither receive one of the planned RMs nor a decremental PEEP trial.

Interventions

Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs PROCEDURE

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

Also known as: Individualized high PEEP strategy with recruitment maneuvers

Individualized high PEEP strategy with recruitment maneuvers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Onze Lieve Vrouwe Gasthuis: collaborator
• HagaZiekenhuis: collaborator
• Dijklander Ziekenhuis: collaborator
• The Netherlands Cancer Institute: collaborator
• Isala: collaborator
• Maasstad Hospital: collaborator
• Medisch Spectrum Twente: collaborator
• University Medical Center Groningen: collaborator
• Leiden University Medical Center: collaborator
• Hospital Universitario La Fe: collaborator
• Ospedale Policlinico San Martino: collaborator
• University Hospital Carl Gustav Carus: collaborator
• Medical University Innsbruck: collaborator
• Spaarne Gasthuis: collaborator
• Zaans Medical Center: collaborator
• Alrijne Hospital: collaborator
• Albert Schweitzer Hospital: collaborator
• Maastricht University Medical Center: collaborator
• Noordwest Ziekenhuisgroep: collaborator

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, Noordholland, 1105AZ, Netherlands

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus Schultz, Professor

  Amsterdam University Medical Center, location AMC

  STUDY CHAIR

• Markus Hollmann, Professor

  Amsterdam University Medical Center, location AMC

  PRINCIPAL INVESTIGATOR

• David van Meenen, PhD

  Amsterdam University Medical Center, location AMC

  PRINCIPAL INVESTIGATOR

• Sabrine Hemmes, PhD

  Amsterdam University Medical Center, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Vermeulen, MD

CONTACT

+ 31 020 566 2533; t.d.vermeulen@amsterdamumc.nl

Galina Dorland, MD

CONTACT

g.dorland@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Intensive Care Medicine, Principal Investigator

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: October 26, 2023
• Study Start: December 11, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the main paper has been published. No end-date has been specified for now.
• Access Criteria: The applicable researcher can contact the Principal investigator with their idea of using the data, preferably accompanied by a statistical analysis plan

Locations

NL (1)