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

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202009582570618

Enrollment

12942

Registered

2020-09-07

Start date

2020-04-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery Anaesthesia

Interventions

Mouthwash and Liberal Oxygen

No Mouthwash and restrictive oxygen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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 American Society of Anesthesiologists (ASA) grade V patients (expected to die with or without surgery)

Design outcomes

Primary

Measure	Time frame
Number of participants with pneumonia using the US Centers for Disease Control (CDC) definition of pneumonia;Number of participants with surgical site infection	—

Secondary

Measure	Time frame
Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons);Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) ;Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions);Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions);Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions);Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions) ;Health resource usage per patient	—

Measure

Time frame

Number of trial participant moralities (Mouthwash and oxygen therapy intervention comparisons);Number of participants who received repeat abdominal surgery to treat complications (Oxygen therapy intervention only) ;Number of participants who received repeat abdominal surgery (Mouthwash and oxygen therapy interventions);Length of hospital stay for index admission (Mouthwash and oxygen therapy interventions);Number of participants returning to normal activities (Mouthwash and oxygen therapy interventions);Number of participants admissions to a critical care unit (Mouthwash and oxygen therapy interventions) ;Health resource usage per patient

—

Countries

South Africa

Contacts

Public ContactMatthew Soden

Senior Trial Manager

penguin@trials.bham.ac.uk+441214144762

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026