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The Relationship Between Oxygen Reserve Index and PaO2

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ClinicalTrials.gov Identifier: NCT03130023
Recruitment Status : Unknown
Verified April 2017 by Jin-Tae Kim, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
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, we will investigate 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 : 500 participants
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
Estimated Study Start Date : May 30, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

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: 30 minutes after ORI application ]


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
  • Requiring invasive arterial blood pressure monitoring

Exclusion Criteria:

  • Presence of any cardiovascular and lung 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
Seoul, Korea, Republic of
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     History of Changes
Other Study ID Numbers: H1705
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
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