NCT04256798 Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
| NCT ID | NCT04256798 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Birmingham |
| Condition | Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 12,942 participants |
| Start Date | 2020-11-13 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 12,942 participants in total. It began in 2020-11-13 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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: * 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)
Contact & Investigator
Rupert Pearse
PRINCIPAL INVESTIGATOR
Royal London Hospital
Frequently Asked Questions
Who can join the NCT04256798 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 100 Years, studying Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04256798 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 12,942 participants.
Is NCT04256798 currently recruiting?
Yes, NCT04256798 is actively recruiting participants. Contact the research team at penguin@trials.bham.ac.uk for enrollment information.
Where is the NCT04256798 trial being conducted?
This trial is being conducted at Botucatu, Brazil, Porto Alegre, Brazil, Porto Alegre, Brazil, Salvador, Brazil and 11 additional locations.
Who is sponsoring the NCT04256798 clinical trial?
NCT04256798 is sponsored by University of Birmingham. The principal investigator is Rupert Pearse at Royal London Hospital. The trial plans to enroll 12,942 participants.