Thoracic Surgery With One-lung VentilationORI-OLVNCT07720778
ORI-Guided Oxygen Therapy During One-Lung Ventilation
A study testing ORI-Guided FiO2 Titration and Conventional SpO₂-Guided FiO₂ Titration in people with Thoracic Surgery With One-lung Ventilation, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thoracic Surgery With One-lung Ventilation
- What is being tested?
- ORI-Guided FiO2 Titration and Conventional SpO₂-Guided FiO₂ Titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥19 years
- Scheduled for elective lung surgery requiring one-lung ventilation
- Written informed consent
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chungsik Oh contact
South Korea1 site
Konkuk University Medical Center
Seoul, Gwangjin-gu, 05030
About this study
Official title: Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
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.
Read the 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
- Being tested
- ORI-Guided FiO2 Titration, Conventional SpO₂-Guided FiO₂ Titration
- Keywords
- One-Lung Ventilation, hyperoxia
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORI-Guided FiO2 TitrationOther
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.
Conventional SpO₂-Guided FiO₂ TitrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional SpO₂-Guided FiO₂ Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min after initiation of one-lung ventilation during operation
Secondary outcomes (4)
Peripheral oxygen saturation (SpO₂)
Peripheral oxygen saturation
Measured: 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)
Oxygen Reserve Index measured during anesthesia.
Measured: 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)
Arterial partial pressure of oxygen measured by arterial blood gas analysis.
Measured: 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)
Fraction of inspired oxygen administered during anesthesia.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery With One-lung VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720778
- Sponsor's protocol ID
- KUMC 2026-05-061
- Acronym
- ORI-OLV
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxygen Reserve Index-Guided Fraction of Inspired Oxygen Titration on the Incidence of Hyperoxemia During One-Lung Ventilation
- ClinicalTrials.gov ID
- NCT07720778
- Acronym / sponsor ID
- ORI-OLV / KUMC 2026-05-061
- Keywords
- One-Lung Ventilation, hyperoxia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORI-Guided FiO2 Titration | Active comparator | Other: ORI-Guided FiO2 TitrationFraction of inspired oxygen (FiO₂) is titrated using both the Oxygen Reserve Index (ORI) and peripheral oxygen saturation (SpO₂) during one-lung ventilation. |
| Conventional SpO₂-Guided FiO₂ Titration | Active comparator | Other: Conventional SpO₂-Guided FiO₂ TitrationFraction of inspired oxygen (FiO₂) is titrated using peripheral oxygen saturation (SpO₂) alone according to the institutional standard of care during one-lung ventilation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥19 years
- Scheduled for elective lung surgery requiring one-lung ventilation
- Written informed consent
Key exclusion criteria (11 listed)
- Severe pulmonary hypertension.
- Left ventricular systolic dysfunction.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORI-Guided FiO2 TitrationDuring 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 | ORI-Guided FiO2 Titration |
| Conventional SpO₂-Guided FiO₂ TitrationDuring one-lung ventilation, FiO₂ is adjusted according to SpO₂ alone. FiO₂ is titrated to maintain SpO₂ ≥98% according to the institutional standard of care. | Other | Conventional SpO₂-Guided FiO₂ Titration |
Primary outcome
Incidence of hyperoxemia during one-lung ventilation
Time frame: 10 min after initiation of one-lung ventilation during operation
Hyperoxemia is defined as an arterial partial pressure of oxygen (PaO₂) greater than 125 mmHg measured after initiation of one-lung ventilation.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chungsik Oh contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORI-Guided FiO2 Titration and Conventional SpO₂-Guided FiO₂ Titration in people with Thoracic Surgery With One-lung Ventilation, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae-Yop Kim (82-10-8811-6942, taeyop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hyperoxemia during one-lung ventilation (time frame: 10 min after initiation of one-lung ventilation during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.