BJA Open (Jun 2025)

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

  • Adesoji Ademuyiwa,
  • Aneel Bhangu,
  • Alisha Bhatt,
  • Bruce Biccard,
  • Sohini Chakrabortee,
  • Richard Crawford,
  • Jyoti Dhiman,
  • Christina George,
  • Dhruv Ghosh,
  • James Glasbey,
  • Pollyanna Hardy,
  • Parvez Haque,
  • Bryar Kadir,
  • Mwayi Kachapila,
  • Harsharan Kaur,
  • Divya Kapoor,
  • Ismail Lawani,
  • Rachel Lillywhite,
  • Laura Magill,
  • Janet Martin,
  • Dion Morton,
  • Rachel Moore,
  • Omar Omar,
  • Rupert Pearse,
  • Antonio Ramos-De la Medina,
  • Tracy Roberts,
  • Emmy Runigamugabo,
  • Donna Smith,
  • Matthew Soden,
  • Atul Suroy,
  • Stephen Tabiri,
  • Neil Winkles,
  • Manisha Aggarwal,
  • Satya Shree Balija,
  • Pradeep Kumar Bhatia,
  • Sharon J. Bannister,
  • Bruce M. Biccard,
  • Julia Brown,
  • Adam BT. Boutall,
  • Sona Chowdhury,
  • Ramkaran Chaudhary,
  • Nonkululo Daniel,
  • Swati Daniel,
  • Neha Desai,
  • Parth Dhamija,
  • Jyoti Dhiman,
  • Iran Duran Sanchez,
  • Maria Fourtounas,
  • Margot G. Flint,
  • Dhruva N. Ghosh,
  • Diana Gonzalez Vazquez,
  • Jyotsna Goswami,
  • Sunita Goyal,
  • Anuj Goyal,
  • Simphiwe W. Gumede,
  • Gurleen Kaur Garry,
  • Parvez D. Haque,
  • Priyanka Hans,
  • Christina George,
  • Deepak Jain,
  • Shaman Jhanji,
  • Ruchi Jakhar,
  • Manoji Joshva,
  • Harsharan Kaur,
  • Karan Kumar,
  • Amit Mahajan,
  • Nikhil Kothari,
  • Rajkumar Kottayasamy Seenivasagam,
  • Ashwani Kumar,
  • Kshitij Kumar,
  • Parmod Kumar,
  • Vaibhav Kumar Varshney,
  • Soeren Laurberg,
  • Kate Leslie,
  • Sonia Mathai,
  • Maria Martinez Lara,
  • Laura Martinez Perez Maldonado,
  • Rachel Moore,
  • Vishal Michael,
  • Sanjeev Misra,
  • Nivedita Sharma,
  • Farhanul Hudda,
  • Nnosa Sentholang,
  • Puneet Pareek,
  • Dharma Ram Poonia,
  • Viplab Patro,
  • Shreya Rayamajhi,
  • Reuben Rajappa,
  • Arti Rajkumar,
  • Antonio Ramos-De la Medina,
  • Kirti Kumar Rathod,
  • Mahaveer Singh Rodha,
  • Sameer Sharma,
  • Naveen Sharma,
  • Subhash Chandra Soni,
  • Shafiq Shajahan,
  • Neil Smart,
  • Marcus Schultz,
  • Sunil Kumar Singh,
  • Ravinder Singh Thind,
  • Jeewan Ram Vishnoi,
  • Simon Cousens,
  • Praveen Talwar,
  • Debendra Kumar Tripathi,
  • Atul Suroy,
  • Graeme S. Wilson,
  • Ly-Mee Yu

Journal volume & issue
Vol. 14
p. 100396

Abstract

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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.

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