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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-100
SponsorUniversity of Birmingham

About this trial

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.

Eligibility criteria

Qualifiers

Adults and children aged 10 years or over

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)

Disqualifiers

Patients undergoing caesarean section

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

Trial design

Treatments tested in this trial

  • Chlorhexidine mouthwash
  • Oxygen
  • Oxygen

Treatment groups

12,942 Participants
are divided into 4 treatment groups

Sponsors and collaborators