The Relationship Between Oxygen Reserve Index and PaO2 | NCT03130023

Studies
The Relationship Between Oxygen Reserve Index and PaO2

NCT03130023

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Sep 5, 2024Actual

Enrollment

98Actual

Phase

Not Applicable

Conditions

Children
Congenital Heart Surgery

Interventions

Pulse Oximeter with ORI

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2020Actual

Primary Completion Date

Dec 20, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Apr 23, 2017

First Submission Date that Met QC Criteria

Apr 23, 2017

First Posted Date

Apr 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2024

Last Update Posted Date

Sep 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test group	Experimental	All subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI.	Device: Pulse Oximeter with ORI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulse Oximeter with ORI	Device	Pulse oximeter that measure Oxygen Reserve Index	Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
correlation coefficient between ORI and PaO2	correlation coefficient between ORI and PaO2	through study completion, an average of 5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age below 7 years
Written informed consent
Undergoing cardiac surgery

Exclusion Criteria:

Presence of cyanotic heart disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Tae Kim, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jin-Tae Kim		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40686277	Derived	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.