ChildrenNCT03130023
The Relationship Between Oxygen Reserve Index and PaO2
A study testing Pulse Oximeter with ORI in people with Children and Congenital Heart Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children. Read more about this study
- Who is it for?
- Ages Up to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Congenital Heart Surgery
- What is being tested?
- Pulse Oximeter with ORI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Feb 2020to 30 Dec 2023
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Age below 7 years
- Written informed consent
- Undergoing cardiac surgery
Who cannot join
- Presence of cyanotic heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Oxygen Reserve Index and PaO2 in Children
Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children.
- Conditions
- Children, Congenital Heart Surgery
- Being tested
- Pulse Oximeter with ORI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Oximeter with ORIDevice
Pulse oximeter that measure Oxygen Reserve Index
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | All subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI. Receives: Device: Pulse Oximeter with ORI |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation coefficient between ORI and PaO2
correlation coefficient between ORI and PaO2
Measured: through study completion, an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start5 Feb 2020
- Primary completion20 Dec 2023
- Study completion30 Dec 2023
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 ChildrenStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130023
- Sponsor's protocol ID
- PED ORI
- Status last verified
- Sep 2024
- First submitted
- 23 Apr 2017
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim JT, Park JB, Ji SH, Jang YE, Kim EH, Kim HS, Lee JH. Dynamics of Oxygen Reserve Index and Arterial Oxygen Partial Pressure in Children: A Prospective Observational Study. Paediatr Anaesth. 2025 Oct;35(10):810-815. doi: 10.1111/pan.70014. Epub 2025 Jul 21.
PubMed 40686277
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Oxygen Reserve Index and PaO2 in Children
- ClinicalTrials.gov ID
- NCT03130023
- Acronym / sponsor ID
- PED ORI
- Conditions
- Children, Congenital Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 26 Apr 2017 (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.
Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Pulse Oximeter with ORIAll subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age below 7 years
- Written informed consent
- Undergoing cardiac surgery
Key exclusion criteria (1 listed)
- Presence of cyanotic heart disease
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 |
|---|---|---|
| Pulse Oximeter with ORIPulse oximeter that measure Oxygen Reserve Index | Device | Test group |
Primary outcome
correlation coefficient between ORI and PaO2
Time frame: through study completion, an average of 5 hours
correlation coefficient between ORI and PaO2
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 5 Sep 2024.
- Derived from this study: PubMed 40686277Kim JT, Park JB, Ji SH, Jang YE, Kim EH, Kim HS, Lee JH. Dynamics of Oxygen Reserve Index and Arterial Oxygen Partial Pressure in Children: A Prospective Observational Study. Paediatr Anaesth. 2025 Oct;35(10):810-815. doi: 10.1111/pan.70014. Epub 2025 Jul 21.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse Oximeter with ORI in people with Children and Congenital Heart Surgery, 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 3 inclusion and 1 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 5 Sep 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?
correlation coefficient between ORI and PaO2 (time frame: through study completion, an average of 5 hours). 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 NCT03130023, 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 5 Sep 2024.