NCT04256798

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 12,942 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 10 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infection
• Pneumonia
• Surgical Site Infection
• Wound Infection
• Surgical Wound Infection
• Postoperative Complications
• Anesthesia
• Communicable Disease
• Pathologic Processes
• Perioperative Complication
• Chlorhexidine
• Laparotomy

Interventions

Type	Name	Description
DRUG	Chlorhexidine mouthwash	0.2% Chlorhexidine digluconate
DRUG	Oxygen	Oxygen 80-100%
DRUG	Oxygen	Oxygen 21-30 %

Timeline

• Start date: 2020-11-13
• Primary completion: 2025-10-31
• Completion: 2026-06-01
• First posted: 2020-02-05
• Last updated: 2025-02-19

Locations

37 sites across 5 countries: Brazil, India, Mexico, Nigeria, South Africa