TY - JOUR
T1 - PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN)
T2 - a randomised international internal pilot trial
AU - PENGUIN Trial Management Group
AU - Ademuyiwa, Adesoji
AU - Bhangu, Aneel
AU - Bhatt, Alisha
AU - Biccard, Bruce
AU - Chakrabortee, Sohini
AU - Crawford, Richard
AU - Dhiman, Jyoti
AU - George, Christina
AU - Ghosh, Dhruv
AU - Glasbey, James
AU - Hardy, Pollyanna
AU - Haque, Parvez D.
AU - Kadir, Bryar
AU - Kachapila, Mwayi
AU - Kaur, Harsharan
AU - Kapoor, Divya
AU - Lawani, Ismail
AU - Lillywhite, Rachel
AU - Magill, Laura
AU - Martin, Janet
AU - Morton, Dion
AU - Moore, Rachel
AU - Omar, Omar
AU - Pearse, Rupert
AU - Ramos-De la Medina, Antonio
AU - Roberts, Tracy
AU - Runigamugabo, Emmy
AU - Smith, Donna
AU - Soden, Matthew
AU - Suroy, Atul
AU - Tabiri, Stephen
AU - Winkles, Neil
AU - NIHR Global Health Research Unit on Global Surgery Collaborators
AU - Aggarwal, Manisha
AU - Balija, Satya Shree
AU - Bhatia, Pradeep Kumar
AU - Bannister, Sharon J.
AU - Biccard, Bruce M.
AU - Brown, Julia
AU - Boutall, Adam BT
AU - Chowdhury, Sona
AU - Chaudhary, Ramkaran
AU - Daniel, Nonkululo
AU - Daniel, Swati
AU - Desai, Neha
AU - Dhamija, Parth
AU - Dhiman, Jyoti
AU - Sanchez, Iran Duran
AU - Fourtounas, Maria
AU - Moore, Rachel
AU - Sharma, Naveen
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/6
Y1 - 2025/6
N2 - 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 (FiO2) 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 FiO2 to prevent surgical site infection (SSI) versus 21–35% FiO2. 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 FiO2 increases in the 21–35% FiO2 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.
AB - 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 (FiO2) 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 FiO2 to prevent surgical site infection (SSI) versus 21–35% FiO2. 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 FiO2 increases in the 21–35% FiO2 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.
KW - abdominal surgery
KW - feasibility study
KW - global health
KW - perioperative care
KW - Pilot trial
KW - postoperative pneumonia
KW - surgical site infection
UR - https://www.scopus.com/pages/publications/105002330132
U2 - 10.1016/j.bjao.2025.100396
DO - 10.1016/j.bjao.2025.100396
M3 - Article
AN - SCOPUS:105002330132
SN - 2772-6096
VL - 14
JO - BJA Open
JF - BJA Open
M1 - 100396
ER -