Intraoperative Oxygen Concentration on Incidence of Surgical Site Infection

High vs Low Inspired Intraoperative Oxygen Concentration on the Incidence of Surgical Site Infection in Hepatobiliary Surgeries

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

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: FIO2=0.8; Drug: FIO2=0.33

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shimaa A Hassan; Phone Number: 01002953253; Email: shimaa.abbas@med.aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Shimaa A Hassan; Phone Number: 01002953253; Email: shimaa.abbas@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: FIO2=0.8; the concentration of intraoperative inspired fraction of oxygen is 80% oxygen + 20% air
Placebo Comparator: 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%	Drug: FIO2=0.33; the concentration of intraoperative inspired fraction of oxygen is 33% oxygen + 66% air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SSI	- the incidence of SSI postoperatively according to the Centers for Disease Control (CDC) criteria up to 30 days	30 DAYS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary complications	defined as the need for controlled ventilation or arterial oxygen saturation below 90% despite supplemental oxygen.	14 days

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: SSI32641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No