HyperoxemiaNCT05912543
A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index in Child
A study testing Titration of FiO2 in people with Hyperoxemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation. Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Hyperoxemia
- What is being tested?
- Titration of FiO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
- Children with American Society of Anesthesiology physical status I, II, III
Who cannot join
- Patient who have chronic respiratory failure
- Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
- Patient whose initial Oxygen Reserve Index value is zero
- Patient who need supplementary oxygen before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: a Randomized Controlled Trial
The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.
Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.
The researchers will compare whether blood oxygen levels were lower in the ORI group.
- Conditions
- Hyperoxemia
- Being tested
- Titration of FiO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of FiO2Procedure or surgery
The inhaled oxygen concentration after one-lung ventilation will be treated by the group.
| Study group | Role | What they receive |
|---|---|---|
| Conventional arm | No intervention | Moderate hyperoxia as determined by T1 arterial blood gas. For moderate hyperoxemia (PaO2 > 300 mmHg), reduce the inspired oxygen concentration to 80% and for severe hyperoxemia to 70%. In the situation of hypoxia, where the peripheral oxygen saturation decreases to less than 95% even in 100% of FiO2, the following treatment is indicated: Fluid administration, inotropes administration (dopamine), alveolar recruitment, return to two-lung ventilation, and application of continuous positive airway pressure. |
| ORI arm | Experimental | Target ORi™ of 0.15, check the ORi™ every 5 minutes and adjust the inspired oxygen concentration in 5% increments. If the ORi™ decreases to less than 0.15, treat it in the same way as if hypoxia occurred in the conventional group. Receives: Procedure: Titration of FiO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
arterial oxygen content over 200
Measured: 30 minutes after initiation of one-lung ventilation
Secondary outcomes (4)
average Oxygen Reserve Index value
Measured: during one lung ventilation
time-weighted average inspired oxygen fraction
Measured: during one lung ventilation
incidence of hypoxemia
Measured: perioperative period
incidence of perioperative complications
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start25 Jun 2023
- Primary completion25 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperoxemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912543
- Sponsor's protocol ID
- 2205-156-1329
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JB, Kang P, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. An adjustment of fraction of inspired oxygen using the oxygen reserve index during one-lung ventilation in pediatric patients: a prospective, randomized controlled trial. Korean J Anesthesiol. 2026 Apr;79(2):224-232. doi: 10.4097/kja.24857. Epub 2025 May 26.
PubMed 40419294
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Titration of Fractional Inspired Oxygen Using Oxygen Reserve Index (ORi™) During One-lung Ventilation in the Pediatric Patient: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05912543
- Acronym / sponsor ID
- 2205-156-1329
- Conditions
- Hyperoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Jun 2023 (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.
The purpose of this prospective randomized controlled trial is to determine whether using the Oxygen Reserve Index can prevent hyperoxemia in pediatric patients receiving single-lung ventilation.
Participants will have their FiO2 adjusted in a prescribed manner based on the arm to which they are assigned.
The researchers will compare whether blood oxygen levels were lower in the ORI group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional arm | No intervention | –Moderate hyperoxia as determined by T1 arterial blood gas. For moderate hyperoxemia (PaO2 > 300 mmHg), reduce the inspired oxygen concentration to 80% and for severe hyperoxemia to 70%. In the situation of hypoxia, where the peripheral oxygen saturation decreases to less than 95% even in 100% of FiO2, the following treatment is indicated: Fluid administration, inotropes administration (dopamine), alveolar recruitment, return to two-lung ventilation, and application of continuous positive airway pressure. |
| ORI arm | Experimental | Procedure: Titration of FiO2Target ORi™ of 0.15, check the ORi™ every 5 minutes and adjust the inspired oxygen concentration in 5% increments. If the ORi™ decreases to less than 0.15, treat it in the same way as if hypoxia occurred in the conventional group. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children under 7 years of age undergoing surgery under unilateral pulmonary ventilation
- Children with American Society of Anesthesiology physical status I, II, III
Key exclusion criteria (4 listed)
- Patient who have chronic respiratory failure
- Patient who have a history of bronchopulmonary dysplasia, respiratory distress syndrome of neonate, laryngomalacia, tracheomalacia or tracheal stenosis
- Patient whose initial Oxygen Reserve Index value is zero
- Patient who need supplementary oxygen before surgery
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 |
|---|---|---|
| Titration of FiO2The inhaled oxygen concentration after one-lung ventilation will be treated by the group. | Procedure or surgery | ORI arm |
Primary outcome
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation)
Time frame: 30 minutes after initiation of one-lung ventilation
arterial oxygen content over 200
4 secondary outcomes
average Oxygen Reserve Index value
Time frame: during one lung ventilation
time-weighted average inspired oxygen fraction
Time frame: during one lung ventilation
incidence of hypoxemia
Time frame: perioperative period
incidence of perioperative complications
Time frame: perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 40419294Park JB, Kang P, Ji SH, Jang YE, Kim EH, Kim JT, Kim HS, Lee JH. An adjustment of fraction of inspired oxygen using the oxygen reserve index during one-lung ventilation in pediatric patients: a prospective, randomized controlled trial. Korean J Anesthesiol. 2026 Apr;79(2):224-232. doi: 10.4097/kja.24857. Epub 2025 May 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration of FiO2 in people with Hyperoxemia, run by Seoul National University Hospital 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of moderate to severe hyperoxemia in arterial blood gas analysis at T2 (30 minutes after one lung ventilation) (time frame: 30 minutes after initiation of one-lung ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912543, which also lists 1 linked publication.
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 17 Dec 2024.