The Relationship Between Oxygen Reserve Index and PaO2

Not Applicable

• Conditions: Children; Congenital Heart Surgery
• Interventions: Device: Pulse Oximeter with ORI

• Registration Number: NCT03130023
• Lead Sponsor: Seoul National University Hospital

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 available

Study Timeline

• Study First Submitted: 2017-04-23
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-26
• Study Start: 2020-02-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Presence of cyanotic heart disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	Pulse Oximeter with ORI	All subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI.

Primary Outcome Measures

Name	Time	Method
correlation coefficient between ORI and PaO2	through study completion, an average of 5 hours	correlation coefficient between ORI and PaO2

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of