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The Relationship Between Oxygen Reserve Index and PaO2

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ClinicalTrials.gov Identifier: NCT03130023
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, 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.

Condition or disease Intervention/treatment Phase
Children Device: Pulse Oximeter with ORI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Relationship Between Oxygen Reserve Index and PaO2 in Children
Actual Study Start Date : February 5, 2020
Estimated Primary Completion Date : January 20, 2022
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. correlation coefficient between ORI and PaO2 [ Time Frame: through study completion, an average of 5 hours ]
    correlation coefficient between ORI and PaO2



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of cyanotic heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130023


Contacts
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Contact: Jin-Tae Kim, PhD +82-2-2072-3592 jintae73@gmail.com

Locations
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Korea, Republic of
Jin-Tae Kim Recruiting
Seoul, Korea, Republic of
Contact: Jin-Tae Kim, MD. PhD    82-2-2072-3295    kimjintae73@dreamwiz.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim, PhD Seoul National University Hospital
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03130023    
Other Study ID Numbers: PED ORI
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No