NCT03130023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
2.8 years until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

April 23, 2017

Last Update Submit

September 2, 2024

Conditions

ChildrenCongenital Heart Surgery

Outcome Measures

Primary Outcomes (1)

  • correlation coefficient between ORI and PaO2

    correlation coefficient between ORI and PaO2

    through study completion, an average of 5 hours

Study Arms (1)

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

Pulse Oximeter with ORIDEVICE

Pulse oximeter that measure Oxygen Reserve Index

Test group

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age below 7 years
  • Written informed consent
  • Undergoing cardiac surgery

You may not qualify if:

  • Presence of cyanotic heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40686277DERIVED

Study Officials

  • Jin-Tae Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

February 5, 2020

Primary Completion

December 20, 2023

Study Completion

December 30, 2023

Last Updated

September 5, 2024

Record last verified: 2024-09

Locations

KR(1)