Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial.
Summary
In this multicentre phase 3 RCT of adults undergoing major open abdominal surgery at intermediate/high PPC risk, adherence to a perioperative lung expansion bundle was high (72–98%). The intervention increased intraoperative mean PEEP relative to usual care; 751 participants were analyzed in the mITT cohort.
Key Findings
- Multicentre phase 3 RCT enrolled 794 patients; mITT analysis included 751 (379 intervention, 372 usual care).
- Adherence to bundle components was high (72–98%).
- Intervention group received higher intraoperative mean PEEP (reported mean 7.5 cmH2O) than usual care.
- Eligibility targeted ARISCAT ≥26 and BMI <35 kg/m² for elective open abdominal surgeries ≥2 hours.
Clinical Implications
Supports structured, individualized intraoperative lung expansion strategies with demonstrable implementation fidelity. Pending full outcome details, programs can emulate high-adherence protocols and PEEP titration strategies in at-risk open abdominal surgeries.
Why It Matters
A large, rigorously conducted NIH-funded RCT addressing PPC mitigation can influence perioperative ventilation bundles and standard practice in open abdominal surgery.
Limitations
- Abstract does not report definitive PPC outcome effect sizes in the provided excerpt.
- Generalizability limited to BMI <35 kg/m² and open abdominal procedures ≥2 hours; blinding of intraoperative teams is inherently challenging.
Future Directions
Report detailed PPC severity and incidence outcomes, subgroup effects (e.g., ARISCAT strata), and implementation across diverse BMI and laparoscopic populations.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Multicentre phase 3 randomized controlled trial with mITT analysis.
- Study Design
- OTHER