Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chlorhexidine mouthwash, Oxygen, Oxygen.
- Who it may be relevant to
- Registry conditions: Infection, Pneumonia, Surgical Site Infection, Wound Infection. Basic parameters: 10 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, India, Mexico, Nigeria, South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PErioperative Respiratory Care and Outcomes for patieNts Undergoing hIgh Risk abdomiNal Surgery: A 2x2 Factorial, International Pragmatic Randomised Controlled Trial Across Low and Middle-income Countries
Overview
PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery. Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.
Detailed description
PENGUIN is a pragmatic, blinded (outcome assessor), 2x2 factorial, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce surgical site infection (SSI) and pneumonia rates in patients undergoing surgery with an abdominal incision.
Pneumonia is one of the most serious complications to occur after surgery, accounting for up to one in four of all postoperative deaths. The incidence is greater still in high-risk populations such as those undergoing midline laparotomy where mortality rates are more than 10%. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery (34, 35). SSIs cause pain, discomfort and disability. They increase the time taken to return to work, and healthcare costs
The risk of postoperative mortality and complications such as surgical site infection is three times greater in low and middle-income countries (LMICs) than in high-income countries. In order to address surgical need worldwide, it is estimated that provision of a further 312 million operations would be required each year.
Patients will be recruited from hospitals in Low and Middle Income Countries (LMICs) who are undergoing elective or emergency mid-line laparotomy. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
A. Preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery B. No preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery C. Preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery D. No preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery
The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main Randomised Control Trial will recruit 12,924 participants.
Interventions
- Drug Chlorhexidine mouthwash
0.2% Chlorhexidine digluconate - Drug Oxygen
Oxygen 80-100% - Drug Oxygen
Oxygen 21-30 %
Primary outcome measures
- Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only) [Time frame: Within 30 days post-surgery from index operation]
- Number of participants with surgical site infection (Oxygen therapy intervention only) [Time frame: Within 30 days post-surgery from index operation]
Secondary outcome measures (7)
- Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons) [Time frame: Within 30 days post-surgery from index operation]
- Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) [Time frame: Within 30 days post-surgery from index operation]
- Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions) [Time frame: Within 30 days post-surgery from index operation]
- Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions) [Time frame: Within 30-days post surgery from index operation]
- Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions) [Time frame: Within 30 days post-surgery from index operation]
- Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions) [Time frame: Within 30 days post-surgery from index operation]
- Health resource usage per patient [Time frame: Within 30 days post-surgery from index operation]
Eligibility criteria
Inclusion criteria
- Adults and children aged 10 years or over
- Elective or emergency abdominal surgery via midline laparotomy with an anticipated abdominal incision of at least 5cm in length
- Written informed consent of patient (signature or a fingerprint)
Exclusion criteria
- Patients undergoing caesarean section
- Patients with a documented or suspected allergy to chlorhexidine
- Patient unable to complete postoperative follow-up (not contactable after discharge)
- Previous enrolment in PENGUIN within the past 30 days
- American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 16 centers
- Homi Bhabha Cancer Hospital & Research Centre — Visakhapatnam
- Sher - i - Kashmir Institute of Medical Sciences — Srinagar
- Chinchpada Christian Hospital — Chinchpāda
- Kasturba Medical College Hospital, Manipal — Madhava Nagar
- Government Medical College, Patiala — Patiāla
- All India Institute of Medical Sciences, Bhubaneswar — Bhubaneswar
- Government Medial College & Hospital, Chandigarh — Chandigarh
- All India Institute of Medical Sciences, Jodhpur — Jodhpur
- … and 8 more centers
Nigeria · 10 centers
- University of Benin Teaching Hospital — Benin City
- University Of Abuja Teaching Hospital — Gwagwalada
- University College Hospital — Ibadan
- Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife
- University of Ilorin Teaching Hospital — Ilorin
- Ahmadu Bello University Teaching Hospital — Kaduna
- Aminu Kano Teaching Hospital — Kano
- Lagos State University Teaching Hospital — Lagos
- … and 2 more centers
Brazil · 5 centers
- Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP — Botucatu
- Hospital de Clinicas de Porto Alegre — Porto Alegre
- Hospital Nossa Senhora da Conceicao — Porto Alegre
- Hospital Universitario Professor Edgar Santos/Bahia — Salvador
- Hospital Sao Jose - Criciuma/SC — São José
South Africa · 4 centers
- Tygerberg Hospital — Cape Town
- Groote Schuur Hospital — Cape Town
- New Somerset Hospital — Cape Town
- Paarl Provincial Hospital — Paarl
Mexico · 2 centers
- Centro Médico Nacional de Occidente IMSS — Belisario Domínguez
- Hospital Espanola Veracruz — Veracruz
Publications
- PENGUIN Trial Management Groupj.glasbey@bham.ac.uk23cgeorge@gmail.com; NIHR Global Health Research Unit on Global Surgery Collaborators; PENGUIN Trial Management Group. PErioperative respiratory care aNd outcomes for patients underGoing hIgh risk abdomiNal surgery (PENGUIN): a randomised international internal pilot trial. BJA Open. 2025 Apr 10;14:100396. doi: 10.1016/j.bjao.2025.100396. eCollecti PMID 40255646
Identifiers
NCT: NCT04256798 · RG_19-223