Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
NCT ID: NCT04256798
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
12942 participants
INTERVENTIONAL
2020-11-13
2026-06-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Mouthwash and liberal oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 80-100% FiO2 during surgery.
Chlorhexidine mouthwash
0.2% Chlorhexidine digluconate
Oxygen
Oxygen 80-100%
No mouthwash and liberal oxygen during surgery
No pre-surgical mouthwash in combination with 80-100% FiO2 during surgery.
Oxygen
Oxygen 80-100%
Mouthwash and restrictive oxygen during surgery
Pre-surgical mouthwash with 0.2% chlorhexidine gluconate in combination with 21-30% FiO2 during surgery.
Chlorhexidine mouthwash
0.2% Chlorhexidine digluconate
Oxygen
Oxygen 21-30 %
No mouthwash and restrictive oxygen during surgery
No pre-surgical mouthwash in combination with 21-30% FiO2 during surgery.
Oxygen
Oxygen 21-30 %
Interventions
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Chlorhexidine mouthwash
0.2% Chlorhexidine digluconate
Oxygen
Oxygen 80-100%
Oxygen
Oxygen 21-30 %
Eligibility Criteria
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Inclusion Criteria
* 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 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)
10 Years
100 Years
ALL
No
Sponsors
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University of Birmingham
OTHER
Responsible Party
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Principal Investigators
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Rupert Pearse
Role: PRINCIPAL_INVESTIGATOR
Royal London Hospital
Locations
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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, India
Sher - i - Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, India
Chinchpada Christian Hospital
Chinchpāda, Maharashtra, India
Kasturba Medical College Hospital, Manipal
Madhava Nagar, Manipal, Karnataka, India
Government Medical College, Patiala
Patiāla, Punjab, India
All India Institute of Medical Sciences, Bhubaneswar
Bhubaneswar, , India
Government Medial College & Hospital, Chandigarh
Chandigarh, , India
All India Institute of Medical Sciences, Jodhpur
Jodhpur, , India
Tata Medical Center
Kolkata, , India
Christian Medical College (CMC) & Hospital, Ludhiana
Ludhiana, , India
Madhepura Christian Hospital
Madhepura, , India
Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital
Mumbai, , India
Tata Memorial Hospital
Mumbai, , India
Maulana Azad Medical College
New Delhi, , India
All India Institute of Medical Sciences, Rishikesh
Rishikesh, , India
Christian Medical College & Hospital Vellore
Vellore, , India
Centro Médico Nacional de Occidente IMSS
Belisario Domínguez, , Mexico
Hospital Espanola Veracruz
Veracruz, , Mexico
University of Benin Teaching Hospital
Benin City, , Nigeria
University Of Abuja Teaching Hospital
Gwagwalada, , Nigeria
University College Hospital
Ibadan, , Nigeria
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, , Nigeria
University of Ilorin Teaching Hospital
Ilorin, , Nigeria
Ahmadu Bello University Teaching Hospital
Kaduna, , Nigeria
Aminu Kano Teaching Hospital
Kano, , Nigeria
Lagos State University Teaching Hospital
Lagos, , Nigeria
Lagos University Teaching Hospital
Lagos, , Nigeria
Nnamdi Azikiwe University Teaching Hospital
Nnewi, , Nigeria
Tygerberg Hospital
Cape Town, , South Africa
Groote Schuur Hospital
Cape Town, , South Africa
New Somerset Hospital
Cape Town, , South Africa
Paarl Provincial Hospital
Paarl, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Leandro Gobbo Braz
Role: primary
Luciana Cadore Stefani
Role: primary
ANDRE PRATO SCHMIDT
Role: primary
Liana Maria Torres De Araujo Azi
Role: primary
Eric Benedet Lineburger
Role: primary
References
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PENGUIN Trial Management [email protected]@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.
Other Identifiers
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RG_19-223
Identifier Type: -
Identifier Source: org_study_id
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