Perioperative medicine & outcomes
PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial
Authors' conclusion
This pilot showed the feasibility and safety of a major phase III trial in post-operative infection prevention in LMICs.
Study context
- Population
- Patients aged ≥10 years undergoing midline laparotomy in LMIC hospitals (India and South Africa)
- Participants
- 927 patients · 7 hospitals
- Comparison
- Preoperative 0.2% chlorhexidine mouthwash vs no mouthwash; 80-100% vs 21-35% perioperative fraction of inspired oxygen (FiO2)
- Primary endpoint
- Feasibility: hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety
- Follow-up
- 12 months
Methodological detailsinternational, outcome assessor-blinded, 2x2 factorial, 907 adults (97.8%) and 20 children aged ten or over (2.2%)
- International
- Outcome assessor-blinded
- 2x2 factorial
- 907 adults (97.8%) and 20 children aged ten or over (2.2%)
Primary result
As reported in the abstract
Feasibility
- Site opening, % of target hospitals (7/10)
- 70%
- Patient recruitment, % of target (927/870)
- 107%
- Received allocated intervention, mouthwash arm (917/927)
- 99%
- Received allocated intervention, oxygen arm (840/927)
- 91%
- 30-day follow-up completed appropriately (924/927)
- 99%
Further findings
Mortality · 30 days
- Patients died (89/927)
- 9.6%
Safety
- Reported safety events
- 0
Original publication
PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial. BJA Open. Published 10 April 2025. doi:10.
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