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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    12942
  • sponsor
    University of Birmingham
Updated on 27 January 2021

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.

Description

PENGUIN is a pragmatic, blinded (outcome assessor), 2x2 factorial, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce surgical site infection (SSI) and pneumonia rates in patients undergoing surgery with an abdominal incision.

Pneumonia is one of the most serious complications to occur after surgery, accounting for up to one in four of all postoperative deaths. The incidence is greater still in high-risk populations such as those undergoing midline laparotomy where mortality rates are more than 10%. SSIs are clearly important being the most frequent healthcare-associated infection in LMICs, affecting one in three patients undergoing contaminated or dirty surgery (34, 35). SSIs cause pain, discomfort and disability. They increase the time taken to return to work, and healthcare costs

The risk of postoperative mortality and complications such as surgical site infection is three times greater in low and middle-income countries (LMICs) than in high-income countries. In order to address surgical need worldwide, it is estimated that provision of a further 312 million operations would be required each year.

Patients will be recruited from hospitals in Low and Middle Income Countries (LMICs) who are undergoing elective or emergency mid-line laparotomy. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:

  1. Preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery B. No preoperative chlorhexidine mouthwash and 80-100% FiO2 during surgery C. Preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery D. No preoperative chlorhexidine mouthwash and 21-30% FiO2 during surgery

The 6 month internal pilot will assess the feasibility of recruitment, compliance with treatment allocation and patient retention and follow-up rates. The main Randomised Control Trial will recruit 12,924 participants.

Details
Condition Pulmonary Disease, Lung Disease, Laparotomy, Postoperative Complication, pathological process, Wound Infection, Infection, Upper respiratory infection, Throat and Tonsil Infections, Pneumonia, Pneumonia, Pneumonia (Pediatric), dental anesthesia, Infection, Postoperative Wound Infection, Chlorhexidine, Anesthesia, Anesthesia (Local), Anesthesia, Throat and Tonsil Infections, Anesthesia (Local), Surgical Site Infection, Surgical Site Infections, Pneumonia (Pediatric), Lung Disease, Perioperative Complication, pathological processes, pneumoniae, pneumonitis, lung inflammation, pathologic processes, pathologic process, sensory loss, surgical wound infection, postoperative complications, postoperative problems, infection, wound, wound infections, anaesthesia, anesthesia for, anesthesia procedures
Treatment Oxygen, Chlorhexidine mouthwash
Clinical Study IdentifierNCT04256798
SponsorUniversity of Birmingham
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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)
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