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NCT07720778

Overview

NCT ID: NCT07720778
Lead Sponsor: Konkuk University Medical CenterOTHER
Official Title: Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
Brief Summary: High inspired oxygen concentrations (FiO₂) are commonly administered during general anesthesia to prevent hypoxemia. However, excessive oxygen administration may result in hyperoxemia, which has been associated with impaired hypoxic pulmonary vasoconstriction, increased oxidative stress, ventilation-perfusion mismatch, and postoperative pulmonary complications.

During one-lung ventilation (OLV) for thoracic surgery, higher FiO₂ is often required because of increased intrapulmonary shunting, making hyperoxemia a frequent occurrence. The Oxygen Reserve Index (ORI) is a noninvasive pulse oximetry-derived parameter that reflects moderate hyperoxemia (PaO₂ approximately 100-200 mmHg) and may facilitate more precise oxygen titration than pulse oximetry alone.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Adults aged ≥19 years

Scheduled for elective lung surgery requiring one-lung ventilation

Written informed consent

Exclusion Criteria:

Severe pulmonary hypertension.

Left ventricular systolic dysfunction.

Withdrawal Criteria:

The participant or legally authorized representative requests withdrawal from the study.

An adverse event occurs that precludes continued participation in the study.

The planned surgery or study procedures are not performed (e.g., ORI monitoring is not applied or arterial blood gas analysis is not performed).

Perfusion Index is less than 2 during the study.

A major violation of the inclusion or exclusion criteria is identified after enrollment.

The participant fails to comply with the study protocol, potentially affecting the validity of the study outcomes.

Continued participation is considered not to be in the participant's best interest.

In the investigator's judgment, any other condition arises that makes continued participation inappropriate.