The Relationship Between Oxygen Reserve Index and PaO2

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.

Study Overview

• Status: Recruiting
• Conditions: Children
• Intervention / Treatment: Device: Pulse Oximeter with ORI

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin-Tae Kim, PhD; Phone Number: +82-2-2072-3592; Email: jintae73@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Presence of cyanotic heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; All subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI.	Device: Pulse Oximeter with ORI; Pulse oximeter that measure Oxygen Reserve Index

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2020
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PED ORI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No