Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial
Primary resultResult — go to the resultAbsolute risk difference −2.68 percentage points 95% CI −6.36 to 1.01Authors' conclusion
In patients with a BMI of less than 35 kg/m2 undergoing thoracic surgery, one-lung ventilation using higher PEEP with recruitment manoeuvres, compared with lower PEEP without recruitment manoeuvres, did not reduce PPCs.
Study context
- Population
- Adults with BMI <35 kg/m² scheduled for open or video-assisted thoracoscopic surgery under GA requiring one-lung ventilation (OLV) with a double-lumen tube, 74 sites in 28 countriesrandomised
- Participants
- 2,200 adults
- Comparison
- High positive end-expiratory pressure (PEEP) vs Low PEEP
- High PEEPn = 1,099
- Low PEEPn = 1,101reference
- Primary endpoint
- Composite of postoperative pulmonary complications (PPCs)
- Follow-up
- First 5 postoperative days
Methodological detailsphase 3, multicentre, international, masked outcome assessment
- Phase 3
- Multicentre
- International
- Masked outcome assessment
Primary result
As reported in the abstract
Absolute risk difference
−2.68 percentage points
95% CI −6.36 to 1.01
P = 0.155
Events by treatment group
High PEEP vs Low PEEP
absolute risk difference −2.68 percentage points (95% CI −6.36 to 1.01); P = 0.155
Further findings
Hypoxaemia rescue manoeuvres
Safety
| Outcome | High PEEP | Low PEEP | Absolute risk difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| Intraoperative complications | 49.8% | 31.3% | 18.09 (14.41–21.77) | |
| Denominator | 972 | 974 | ||
| −100102030Difference, percentage points (linear scale) |
Intraoperative hypotension · more frequent in the high PEEP group
Denominator High PEEP 966 · Low PEEP 978
Intraoperative new arrhythmias
- New arrhythmias, high PEEP vs low PEEP: 89 [9.9%] of 899 vs 37 [3.9%] of 956; more frequent in the high PEEP group
Intraoperative hypoxaemia rescue manoeuvres
- Hypoxaemia rescue manoeuvres, high PEEP vs low PEEP: 29 [3.3%] of 888 vs 86 [8.8%] of 982; more frequent in the low PEEP group
Extrapulmonary postoperative complications
- Extrapulmonary postoperative complications: 110 [10.6%] of 1036 vs 107 [10.2%] of 1049 patients; did not differ between groups
Adverse events
- Numbers of adverse events: 209 vs 204 events; did not differ between groups
Original publication
Effects of intraoperative higher versus lower positive end-expiratory pressure during one-lung ventilation for thoracic surgery on postoperative pulmonary complications (PROTHOR): a multicentre, international, randomised, controlled, phase 3 trial. Lancet Respir Med. Published 12 November 2025. doi:10.
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