ORI-Guided Oxygen Therapy During One-Lung Ventilation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ORI-Guided FiO2 Titration, Conventional SpO₂-Guided FiO₂ Titration.
- Who it may be relevant to
- Registry conditions: Thoracic Surgery With One-lung Ventilation. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
Overview
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.
Detailed description
This prospective, randomized, assessor-blinded clinical trial aims to determine whether FiO₂ titration guided by both ORI and peripheral oxygen saturation (SpO₂) reduces the incidence of hyperoxemia compared with conventional SpO₂-guided FiO₂ titration during OLV in patients undergoing thoracic surgery. Participants will be randomly assigned to either an ORI-guided group or a conventional SpO₂-guided group. The primary outcome is the incidence of hyperoxemia (PaO₂ \>125 mmHg) after OLV. Secondary outcomes include SpO₂, ORI, PaO₂, and FiO₂ measured
Interventions
- Other ORI-Guided FiO2 Titration
During one-lung ventilation, FiO₂ is adjusted according to both ORI and SpO₂. FiO₂ is titrated to maintain SpO₂ ≥98% while keeping ORI above 0 to minimize hyperoxemia. - Other Conventional SpO₂-Guided FiO₂ Titration
During one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone. FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care.
Primary outcome measures
- Incidence of hyperoxemia during one-lung ventilation [Time frame: 10 min after initiation of one-lung ventilation during operation]
Secondary outcome measures (4)
- Peripheral oxygen saturation (SpO₂) [Time frame: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
- Oxygen Reserve Index (ORI) [Time frame: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
- Arterial oxygen tension (PaO₂) [Time frame: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
- Fraction of inspired oxygen (FiO₂) [Time frame: 10 mins after two-lung ventilation, 10 mins after initiation of one-lung ventilation, and 10 mins after resumption of two-lung ventilation, all time frames are included in anesthesia time]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Konkuk University Medical Center — Seoul
Identifiers
NCT: NCT07720778 · KUMC 2026-05-061