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

Not Applicable

Recruiting

• Conditions: Surgery; Postoperative Complications
• Interventions: Procedure: Intraoperative ventilation with individualized high PEEP titrated to the lowest ΔP with RMs

• Registration Number: NCT06101511
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-26
• Study Start: 2023-12-11
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-06-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1806

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized high PEEP strategy with recruitment maneuvers	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 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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants developing one or more postoperative pulmonary complications (PPCs)	The first 5 postoperative days	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

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	For the duration of general anesthesia, these outcomes are scored every hour up to a maximum of 18 hours	Including: any episode of desaturation; any episode of hypotension; any need for vasoactive agents, either as bolus or continuous administration, defined as more than needed to compensate for vasodilating effects of anesthesia as judged by the attending anesthesiologist and any new arrhythmias needing intervention
Intraoperative fluid strategy	During general anesthesia	Including the total amount of fluids administered during anesthesia, including the amounts of colloids, crystalloids, and blood products
Antibiotics use	The first 5 postoperative days	Use of antibiotics for pneumonia (proportion of patients who received antibiotics)
Length of stay	Postoperatively until the end of the 90 day follow-up period	Length of hospital stay (days); length of ICU admission if applicable (days);
Thoracic imaging	The first 5 postoperative days	Occurence of imaging (chest X-ray, computed tomography scan). Proportion of patients who underwent thoracic imaging.
Oxygen use	The first 5 postoperative days	Postoperative supplemental oxygen use (days). Presence, duration and levels of postoperative supplemental oxygen
Impaired wound healing	The first 5 postoperative days	Impaired wound healing, as judged and mentioned in the medical record by the attending ward physician;
Postoperative extrapulmonary complications	The first 5 postoperative days	Including: sepsis; septic shock; extrapulmonary infection; anastomotic leak and acute renal failure
Mortality	Postoperative day 5, day 30 and day 90	All-cause mortality at day 5, day 30 and 90, and in-hospital mortality

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noordholland, Netherlands