ORI-Guided Oxygen Therapy During One-Lung Ventilation

NCT07720778 | Not Yet Recruiting

• 1 other identifier: KUMC 2026-05-061
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Thoracic Surgery With One-lung Ventilation

Keywords

One-Lung Ventilation; hyperoxia

Outcome Measures

Primary Outcomes (1)

• Incidence of hyperoxemia during one-lung ventilation

  Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation.

  10 min after initiation of one-lung ventilation during operation

Secondary Outcomes (4)

• Peripheral oxygen saturation (SpO₂)

  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)

  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)

  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)

  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

Study Arms (2)

ORI-Guided FiO2 Titration

ACTIVE COMPARATOR

Fraction of inspired oxygen (FiO₂) is titrated using both the Oxygen Reserve Index (ORI) and peripheral oxygen saturation (SpO₂) during one-lung ventilation.

Other: ORI-Guided FiO2 Titration

Conventional SpO₂-Guided FiO₂ Titration

ACTIVE COMPARATOR

Fraction of inspired oxygen (FiO₂) is titrated using peripheral oxygen saturation (SpO₂) alone according to the institutional standard of care during one-lung ventilation.

Other: Conventional SpO₂-Guided FiO₂ Titration

Interventions

ORI-Guided FiO2 Titration OTHER

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.

ORI-Guided FiO2 Titration

Conventional SpO₂-Guided FiO₂ Titration OTHER

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.

Conventional SpO₂-Guided FiO₂ Titration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥19 years
• Scheduled for elective lung surgery requiring one-lung ventilation
• Written informed consent

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Gwangjin-gu, 05030, South Korea

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tae-Yop Kim

CONTACT

82-10-8811-6942; taeyop@gmail.com

Chungsik Oh

CONTACT

iamchungsik@daum.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)