NCT07885124 Driving Pressure-Guided Individualized PEEP Versus Standard PEEP: Effects on Postoperative Pulmonary Complications in Upper Abdominal Digestive Surgery
| NCT ID | NCT07885124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hopital Charles Nicolle |
| Condition | Postoperative Pulmonary Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2027-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2026-05-22 with a primary completion date of 2027-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07885124 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Pulmonary Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07885124 currently recruiting?
Yes, NCT07885124 is actively recruiting participants. Contact the research team at hallouma.benfredj@fmt.utm.tn for enrollment information.
Where is the NCT07885124 trial being conducted?
This trial is being conducted at Tunis, Tunisia.
Who is sponsoring the NCT07885124 clinical trial?
NCT07885124 is sponsored by Hopital Charles Nicolle. The trial plans to enroll 210 participants.