Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

NCT ID: NCT06108791

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2026-11-30

Brief Summary

Surgical site infections (SSI) are the most common healthcare-associated infections and sources of morbidity and over-mortality. Factors that have been proven to reduce SSI include antimicrobial prophylaxis, maintenance of perioperative normothermia, avoidance of hyperglycemia, proper surgical techniques, and adequate pain relief postoperatively

Detailed Description

In 2016, a systematic review and meta-analysis assessing the effects of systematic high FiO2 (80%) compared with standard FiO2 (30%) concluded that high FiO2 was associated with a reduction of SSI in patients undergoing surgery under general anesthesia. Consequently, the WHO recommended that "adult patients undergoing general anesthesia should receive an 80% FiO2 intra-operatively to reduce the risk of SSI".These recommendations have sparked a large debate on the benefits and harms of hyperoxemia. From the theoretical point-of-view, several pro (prevention of hypoxemia, SSI, and postoperative nausea and vomiting) and con (respiratory adverse events, increased production of harmful "reactive oxygen species") arguments have been raised by believers and detractors of high FiO2. Accordingly, and despite these recommendations, anesthetists still used a wide range of intraoperative FiO2 in daily practice and frequently changed FiO2 settings during surgery unrelated to patients' PaO2 or SpO2.

The PROXI study, the largest multicenter randomized controlled trial specifically designed to assess the role of high vs. low intraoperative FiO2 on SSI, did not report any reduction of the incidence of SSI with the administration of 80% FiO2 during colorectal surgery. Similarly, the recent multicenter randomized iPROVE-O2 trial that included 740 patients undergoing major abdominal surgery, ventilated intraoperatively with an evidence-based protective strategy, reported a similar SSI rate between the 30% and 80% FiO2 groups.

Conditions

Surgical Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

HIGH FIO2

will include 50 patients: each one will receive intraoperatively a high concentration of oxygen (80% oxygen + 20% air), following extubation, high-concentration oxygen supplementation will be maintained and given through non-rebreathing face mask with a reservoir at 10 L/min for 2 h.

Group Type: ACTIVE_COMPARATOR

FIO2=0.8

Intervention Type: DRUG

the concentration of intraoperative inspired fraction of oxygen is 80% oxygen + 20% air

LOW FIO2

will include 50 patients: each one will receive intraoperatively standard concentration oxygen (33% oxygen + 66% air) followed by oxygen supplementation through the standard Venturi face mask of 30%

Group Type: PLACEBO_COMPARATOR

FIO2=0.33

Intervention Type: DRUG

the concentration of intraoperative inspired fraction of oxygen is 33% oxygen + 66% air

Interventions

FIO2=0.8

the concentration of intraoperative inspired fraction of oxygen is 80% oxygen + 20% air

Intervention Type: DRUG

FIO2=0.33

the concentration of intraoperative inspired fraction of oxygen is 33% oxygen + 66% air

Intervention Type: DRUG

Eligibility 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shimaa Abbas Hassan

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Shimaa A Hassan

Role: CONTACT

shimaa.abbas@med.aun.edu.eg

01002953253

Facility Contacts

Shimaa A Hassan

Role: primary

shimaa.abbas@med.aun.edu.eg

01002953253

Other Identifiers

SSI32641

Identifier Type: -

Identifier Source: org_study_id