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

What this Trial Is About

Researchers are investigating the effects of pre-operative mouthwash and varying oxygen levels during surgery on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This trial focuses on patients in low and middle-income countries, where postoperative complications are more common and often more severe. The study aims to find ways to reduce these serious complications, which can cause pain, disability, and increased healthcare costs. Participants will be randomly assigned to one of four groups: pre-operative chlorhexidine mouthwash combined with high oxygen levels (80-100% FiO2), no mouthwash with high oxygen levels, mouthwash with low oxygen levels (21-30% FiO2), or no mouthwash with low oxygen levels. Treatments are given around the time of surgery, with oxygen delivered during the operation and mouthwash used before surgery. The study includes an internal pilot phase lasting six months to check recruitment and compliance, followed by a larger trial aiming to enroll nearly 13,000 participants. During the study, researchers will monitor participants for up to 30 days after surgery, assessing rates of pneumonia and surgical site infections using CDC definitions. They will also track other outcomes like mortality, repeat surgeries, hospital stay length, return to normal activities, critical care admissions, and healthcare resource use. Follow-up includes evaluating patient recovery and safety, with all data collected to understand how these interventions impact surgical outcomes in these settings.

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