Effects of oxygen concentration during surgery on infection rates
High vs Low Inspired Intraoperative Oxygen Concentration on the Incidence of Surgical Site Infection in Hepatobiliary Surgeries
This study tests whether using higher oxygen levels during surgery can help reduce the risk of infections for patients having elective abdominal surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06108791 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different intraoperative oxygen concentrations on the incidence of surgical site infections (SSI) in patients undergoing elective abdominal surgeries. It compares the effects of high oxygen concentration (80% FiO2) versus standard oxygen concentration (33% FiO2) during general anesthesia. The study aims to clarify the ongoing debate regarding the benefits and risks of hyperoxemia in surgical settings, particularly in light of conflicting results from previous trials. By enrolling patients with specific eligibility criteria, the study seeks to provide clearer evidence on the optimal oxygen levels to minimize SSI.
Who should consider this trial
Good fit: Ideal candidates are patients with a BMI under 35 scheduled for elective abdominal laparotomy or laparoscopy under general anesthesia with a surgical duration of over 2 hours.
Not a fit: Patients undergoing minor procedures, emergency surgeries, or those with uncontrolled diabetes or immunological dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes by reducing the incidence of surgical site infections.
How similar studies have performed: Previous studies have shown mixed results regarding the impact of high FiO2 on SSI, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- BMI of \<35 kg/m2 * scheduled for elective abdominal laparotomy/ laparoscopy under general anesthesia with an expected surgical time longer than 2 h. * ASA I and II Exclusion Criteria: * \- Patients undergoing minor procedures, where the expected duration of surgery will be less than 1 hour. * emergency surgeries for bowel obstruction. * abdominal surgery for vascular or plastic indications. * patients with a recent history of fever, * patients with uncontrolled diabetes mellitus, * patient with known immunological dysfunction (on steroids, decompensated liver disease, HIV, etc.).
Where this trial is running
Asyut
- Assiut University — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Shimaa A Hassan
- Email: shimaa.abbas@med.aun.edu.eg
- Phone: 01002953253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.