PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial.

BACKGROUND

Infections are a common complication of abdominal surgery in low- and middle-income countries (LMICs). The role of a high fraction of inspired oxygen (FiO) and chlorhexidine mouthwash in preventing post-operative infections is unconfirmed.

METHODS

Internal pilot phase of an international outcome assessor-blinded, 2x2 factorial randomised trial of patients aged ≥10-years undergoing midline laparotomy in LMIC hospitals. The main trial objectives are to compare the clinical effectiveness of preoperative 0.2% chlorhexidine mouthwash in preventing pneumonia versus no mouthwash, and 80-100% perioperative FiO to prevent surgical site infection (SSI) versus 21-35% FiO. This 12-month internal pilot assessed feasibility of hospital site opening, patient recruitment, intervention adherence, patient follow-up and safety. Patients were randomised in a 1:1:1:1 ratio to the four intervention group combinations and followed up for 30 days.

RESULTS

We recruited 927 patients from seven hospitals in India and South Africa over 12 months from November 2020. There were 907 adults (97.8%) and 20 children aged ten or over (2.2%): 89/927 (9.6%) patients died. Site opening reached 70% of our target (7/10) hospitals, and patient recruitment 107% (927/870). 917/927 (99%) patients in the mouthwash arm, and 840/927 (91%) patients in the oxygen arm received the allocated intervention. Lower adherence to the oxygen intervention related mainly to clinically necessary FiO increases in the 21-35% FiO arm. 30-day follow-up was completed appropriately for 924/927 (99%) patients. and was performed by a masked assessor for all patients. There were no reported safety events.

CONCLUSION

This pilot showed the feasibility and safety of a major phase III trial in post-operative infection prevention in LMICs.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04256798.