drugset / Trial / NCT04256798

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

NCT04256798

Phase 3 Recruiting 12942 enrolled University of Birmingham
RandomizedFactorialSingle-blindTreatment

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.

Timeline

Start
2020-11-13
Primary completion
2025-10-31
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule 0.2 %
Subject Oxygen Other / unclassified 21 %
Subject Oxygen Other / unclassified 30 %
Subject Oxygen Other / unclassified 80 %
Subject Oxygen Other / unclassified 100 %