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Oxygen Reserve Index Guided FiO₂ Titration in One-Lung Ventilation

NCT07359833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-22

No results posted yet for this study

Summary

One-lung ventilation (OLV) is routinely used during thoracic surgery to facilitate surgical exposure but is associated with an increased risk of intraoperative hypoxemia. To prevent hypoxia, high fractions of inspired oxygen (FiO₂) are commonly administered; however, excessive oxygen delivery may lead to hyperoxia and oxidative tissue injury. The Oxygen Reserve Index (ORi) is a novel, noninvasive monitoring parameter that provides real-time information on moderate hyperoxia and may allow more precise titration of FiO₂ during anesthesia.

The aim of this prospective, randomized clinical trial is to evaluate whether ORi-guided intraoperative oxygen management can reduce oxygen exposure during OLV without increasing hypoxemia and to assess its effects on oxidative stress biomarkers and postoperative outcomes. Adult patients undergoing elective thoracic surgery with OLV are randomized to receive either ORi-guided FiO₂ titration or conventional oxygen management. Oxidative stress biomarkers and postoperative pulmonary complications are compared between groups.

Conditions

  • One Lung Ventilation in Thoracic Surgery

Interventions

DEVICE

Oxygen Reserve Index (ORi)-guided oxygen titration

FiO₂ adjusted intraoperatively according to predefined ORi thresholds during thoracic surgery and one lung ventilation period.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Buğra Aykenar · Gazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-05
Primary Completion
2023-07-15
Completion
2023-08-30
FDA Device
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07359833 on ClinicalTrials.gov