Driving pressure-guided individualized PEEP vs standard PEEP during upper abdominal surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, randomized trial compares two strategies for setting PEEP during general anesthesia in adults undergoing supra-mesocolic upper abdominal digestive surgery. All participants receive lung-protective ventilation; one group has PEEP tailored to achieve the lowest driving pressure after a lung recruitment maneuver, while the other group maintains PEEP at 5 cmH2O. The primary endpoint is the occurrence of one or more postoperative pulmonary complications within the first 7 days after surgery. Outcomes are assessed by an independent postoperative assessor, with care standardized across groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Charles Nicole Hospital
  Tunis, Tunisia Recruiting

Study contacts

• Study coordinator: Hallouma Ben Fredj, MD
• Email: hallouma.benfredj@fmt.utm.tn
• Phone: 25207433

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.