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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03130023
Other study ID # PED ORI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 5, 2020
Est. completion date December 30, 2023

Study information

Verified date May 2022
Source Seoul National University Hospital
Contact Jin-Tae Kim, PhD
Phone +82-2-2072-3592
Email jintae73@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 7 Years
Eligibility Inclusion Criteria: - Age below 7 years - Written informed consent - Undergoing cardiac surgery Exclusion Criteria: - Presence of cyanotic heart disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pulse Oximeter with ORI
Pulse oximeter that measure Oxygen Reserve Index

Locations

Country Name City State
Korea, Republic of Jin-Tae Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary correlation coefficient between ORI and PaO2 correlation coefficient between ORI and PaO2 through study completion, an average of 5 hours
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