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

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.

• Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons) [Срок оценки: Within 30 days post-surgery from index operation]
• Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) [Срок оценки: Within 30 days post-surgery from index operation]
• Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions) [Срок оценки: Within 30 days post-surgery from index operation]
• Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions) [Срок оценки: Within 30-days post surgery from index operation]
• Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions) [Срок оценки: Within 30 days post-surgery from index operation]
• Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions) [Срок оценки: Within 30 days post-surgery from index operation]
• Health resource usage per patient [Срок оценки: Within 30 days post-surgery from index operation]