Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
PENGUIN
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
1 other identifier
interventional
12,942
5 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedFebruary 19, 2025
February 1, 2025
5 years
January 31, 2020
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia (Mouthwash intervention only)
Pneumonia will be classified using the US Centers for Disease Control (CDC) definition of pneumonia
Within 30 days post-surgery from index operation
Number of participants with surgical site infection (Oxygen therapy intervention only)
The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision AND The patient must have at least one of the following: * Purulent drainage from the wound * Organisms are detected from a wound swab * Wound opened spontaneously or by a clinician AND, fever (\>38°C), OR at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; * Diagnosis of SSI by a clinician or radiological imaging
Within 30 days post-surgery from index operation
Secondary Outcomes (7)
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons)
Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only)
Within 30 days post-surgery from index operation
Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions)
Within 30 days post-surgery from index operation
Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions)
Within 30-days post surgery from index operation
Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions)
Within 30 days post-surgery from index operation
- +2 more secondary outcomes
Study Arms (4)
Mouthwash and liberal oxygen during surgery
EXPERIMENTALPre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.
No mouthwash and liberal oxygen during surgery
ACTIVE COMPARATORNo pre-surgical mouthwash in combination with 80-100% FiO2 during surgery.
Mouthwash and restrictive oxygen during surgery
EXPERIMENTALPre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.
No mouthwash and restrictive oxygen during surgery
ACTIVE COMPARATORNo pre-surgical mouthwash in combination with 21-30% FiO2 during surgery.
Interventions
0.2% Chlorhexidine digluconate
Oxygen 80-100%
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Hospital das Clinicas da Faculdade de Medicina de Botucatu - UNESP
Botucatu, São Paulo, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Brazil
Hospital Universitario Professor Edgar Santos/Bahia
Salvador, Brazil
Hospital Sao Jose - Criciuma/SC
São José, Brazil
Homi Bhabha Cancer Hospital & Research Centre
Visakhapatnam, Andhra Pradesh, 530053, India
Sher - i - Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, 190011, India
Chinchpada Christian Hospital
Chinchpāda, Maharashtra, 425417, India
Kasturba Medical College Hospital, Manipal
Madhava Nagar, Manipal, Karnataka, 576104, India
Government Medical College, Patiala
Patiāla, Punjab, 147001, India
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, 751019, India
Government Medial College & Hospital, Chandigarh
Chandigarh, 160047, India
All India Institute of Medical Sciences, Jodhpur
Jodhpur, 342005, India
Tata Medical Center
Kolkata, 700160, India
Christian Medical College (CMC) & Hospital, Ludhiana
Ludhiana, 141008, India
Madhepura Christian Hospital
Madhepura, 852113, India
Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital
Mumbai, 400008, India
Tata Memorial Hospital
Mumbai, 400012, India
Maulana Azad Medical College
New Delhi, 110002, India
All India Institute of Medical Sciences, Rishikesh
Rishikesh, 249203, India
Christian Medical College & Hospital Vellore
Vellore, 632004, India
Centro Médico Nacional de Occidente IMSS
Belisario Domínguez, 44329, Mexico
Hospital Espanola Veracruz
Veracruz, 91700, Mexico
University of Benin Teaching Hospital
Benin City, 300283, Nigeria
University Of Abuja Teaching Hospital
Gwagwalada, 902101, Nigeria
University College Hospital
Ibadan, 200285, Nigeria
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, 233285, Nigeria
University of Ilorin Teaching Hospital
Ilorin, 241102, Nigeria
Ahmadu Bello University Teaching Hospital
Kaduna, 810105, Nigeria
Aminu Kano Teaching Hospital
Kano, 700101, Nigeria
Lagos State University Teaching Hospital
Lagos, 101233, Nigeria
Lagos University Teaching Hospital
Lagos, 102215, Nigeria
Nnamdi Azikiwe University Teaching Hospital
Nnewi, 435101, Nigeria
Tygerberg Hospital
Cape Town, 7505, South Africa
Groote Schuur Hospital
Cape Town, 7925, South Africa
New Somerset Hospital
Cape Town, 8001, South Africa
Paarl Provincial Hospital
Paarl, 7646, South Africa
Related Publications (1)
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. eCollection 2025 Jun.
PMID: 40255646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rupert Pearse
Royal London Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 5, 2020
Study Start
November 13, 2020
Primary Completion
October 31, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
February 19, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 6 months post publication
- Access Criteria
- Formal requests must be submitted to the Data Access Group at Birmingham Clinical Trials Unit
Data will be shared via a process of controlled access