Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery

NCT07885124 | Recruiting

• 1 other identifier: CharlesNicolle Hospital
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial compares two methods of setting positive end-expiratory pressure (PEEP) during general anesthesia in adults undergoing upper abdominal digestive surgery who are at moderate or high risk of postoperative pulmonary complications. All participants will receive lung-protective mechanical ventilation. Participants will be randomly assigned to one of two groups. In the individualized PEEP group, PEEP will be adjusted to achieve the lowest driving pressure following a lung recruitment maneuver. In the standard PEEP group, PEEP will be fixed at 5 cmH2O. The main question is whether driving pressure-guided individualized PEEP reduces the proportion of participants who develop one or more postoperative pulmonary complications during the first 7 days after surgery compared with standard PEEP.

Conditions

Postoperative Pulmonary Complications; Mechanical Ventilation

Keywords

Driving Pressure; Individualized PEEP; Positive End-Expiratory Pressure; PEEP Titration; Lung Recruitment Maneuver; Lung-Protective Ventilation; Upper Abdominal Surgery; ARISCAT Score; Perioperative Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  Incidence of postoperative pulmonary complications occurring within the first 7 postoperative days, according to the study-defined criteria.

  From the end of surgery through postoperative day 7 (up to 7 days)

Secondary Outcomes (14)

• Length of hospital stay

  From the day of surgery through hospital discharge, assessed up to 30 days after surgery.

• Postoperative Intensive Care Unit Admission

  From the end of surgery through hospital discharge, assessed up to 30 days after surgery.

• Intensive Care Unit Length of Stay

  At intensive care unit discharge, assessed up to 30 days after surgery.

• Intraoperative Tidal Volume

  10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.

• Median Intraoperative Positive End-Expiratory Pressure

  10 minutes after tracheal intubation; 1, 2, and 3 hours after intubation; and at the end of surgery.

Study Arms (2)

Driving Pressure-Guided Individualized PEEP

EXPERIMENTAL

Participants receive a lung recruitment maneuver followed by a decremental PEEP trial. The PEEP level associated with the lowest driving pressure is selected, provided that adequate oxygenation and hemodynamic stability are maintained.

Procedure: Driving Pressure-Guided Individualized PEEP

Standard PEEP

ACTIVE COMPARATOR

Participants receive lung-protective mechanical ventilation with a fixed PEEP of 5 cmH2O throughout the intraoperative ventilation period.

Procedure: Standard PEEP

Interventions

Driving Pressure-Guided Individualized PEEP PROCEDURE

Participants assigned to this experimental arm receive a lung recruitment maneuver followed by a decremental PEEP trial. Driving pressure is calculated as plateau pressure minus PEEP at each tested level. The PEEP associated with the lowest driving pressure is selected and maintained during surgery, provided that adequate oxygenation and hemodynamic stability are preserved.

Driving Pressure-Guided Individualized PEEP

Standard PEEP PROCEDURE

Participants receive lung-protective mechanical ventilation with PEEP fixed at 5 cmH2O throughout the intraoperative ventilation period. The other components of perioperative ventilation and care are standardized between the two groups.

Standard PEEP

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older.
• Scheduled for supra-mesocolic upper abdominal digestive surgery.
• American Society of Anesthesiologists (ASA) physical status I, II, or stable III.
• Moderate or high risk of postoperative pulmonary complications, defined by an Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score of 26 or higher.
• Provision of written informed consent.

You may not qualify if:

• Refusal to participate or inability to provide written informed consent.
• Pregnancy.
• ASA physical status greater than III.
• History of acute respiratory distress syndrome.
• Pulmonary hypertension.
• Bronchopleural fistula.
• Chronic obstructive pulmonary disease with severe emphysema.
• Pre-existing cardiac arrhythmia.
• Decompensated heart failure.
• Known condition associated with increased intracranial pressure.
• Intra-abdominal hypertension.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicole Hospital

Tunis, 2068, Tunisia

RECRUITING

Related Publications (1)

• PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.

  PMID: 24894577 BACKGROUND

Central Study Contacts

Hallouma Ben Fredj, MD

CONTACT

25207433; hallouma.benfredj@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are unaware of their assigned group because the intervention is performed during general anesthesia. Postoperative outcomes are assessed by an independent investigator who is unaware of treatment allocation. The anesthesia team applying the ventilation strategy cannot be masked but does not participate in postoperative outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care

Model Details: Two-arm, parallel-group, randomized controlled trial. Participants are assigned in a 1:1 ratio to either driving pressure-guided individualized PEEP or standard PEEP. Each participant remains in the assigned group throughout the intraoperative intervention, with no crossover between groups.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: October 21, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): June 22, 2027
• Study Completion (Estimated): June 22, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)