Lowering driving pressure during surgeries with high risk of postoperative lung complications
Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
This trial tests whether using the lowest possible driving pressure during mechanical ventilation instead of standard protective settings helps adults having high-risk surgery avoid postoperative lung complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University General Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai) |
| Trial ID | NCT07186933 on ClinicalTrials.gov |
What this trial studies
Adults at high risk for postoperative pulmonary complications (ARISCAT score >25) who undergo surgery with general anesthesia and invasive ventilation will receive one of two perioperative ventilation strategies. One group receives conventional lung-protective ventilation and the other undergoes PEEP titration to minimize driving pressure (ΔP). Investigators will compare rates of postoperative pulmonary complications as well as length of hospital stay, ICU admission, and mortality between the groups. All interventions and follow-up are performed at the University Hospital of Patras according to local perioperative care.
Who should consider this trial
Good fit: Adults scheduled for surgery under general anesthesia who will be invasively ventilated and have a preoperative ARISCAT score above 25 are eligible candidates.
Not a fit: Patients who are pregnant, not having general anesthesia with endotracheal intubation, have severe heart failure or severe emphysematous lung disease, or cannot tolerate neuromuscular blockade or cessation of spontaneous ventilation are unlikely to participate or benefit.
Why it matters
Potential benefit: If successful, the lower-driving-pressure approach could reduce postoperative lung complications, shorten hospital stays, and decrease ICU needs and possibly mortality for high-risk surgical patients.
How similar studies have performed: Observational studies and ARDS research associate lower driving pressure with better outcomes, but randomized evidence in high-risk surgical patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * \>17 years old * Surgery with general anesthesia \& invasive mechanical ventilation * Preoperative ARISCAT score estimation \>25 Exclusion Criteria: * \<18 years old * Preoperative ARISCAT score estimation \<26 * Women during pregnancy or just given birth * Other type of anesthesia (Not general) * Contraindication of administration of neuromuscular blockade agents. * Contraindication of cease of spontaneous ventilation. * Mechanical ventilation without endotracheal intubation. * Severe heart failure / Severe cardiac arrhythmia. * Severe emphysematous lung disease. * Patient denial of participation in the trial.
Where this trial is running
Pátrai
- University Hospital of Patras — Pátrai, Greece (Recruiting)
Study contacts
- Principal investigator: Antonios Kostouros, Resident — University of Patras
- Study coordinator: Antonios D Kostouros, Resident
- Email: kostouros.a@yahoo.com
- Phone: +306975920528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.