Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Relationship Between Oxygen Reserve Index and PaO2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 23, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date March 25, 2020
Actual Study Start Date  ICMJE February 5, 2020
Estimated Primary Completion Date January 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
correlation coefficient between ORI and PaO2 [ Time Frame: through study completion, an average of 5 hours ]
correlation coefficient between ORI and PaO2
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2017)
correlation coefficient between ORI and PaO2 [ Time Frame: 30 minutes after ORI application ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Relationship Between Oxygen Reserve Index and PaO2
Official Title  ICMJE The Relationship Between Oxygen Reserve Index and PaO2 in Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Children
Intervention  ICMJE Device: Pulse Oximeter with ORI
Pulse oximeter that measure Oxygen Reserve Index
Study Arms  ICMJE Experimental: Test group
All subjects will be enrolled in the test group and will receive Pulse Oximeter with ORI.
Intervention: Device: Pulse Oximeter with ORI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2017)
500
Estimated Study Completion Date  ICMJE January 30, 2022
Estimated Primary Completion Date January 20, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of cyanotic heart disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jin-Tae Kim, PhD +82-2-2072-3592 jintae73@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130023
Other Study ID Numbers  ICMJE PED ORI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Tae Kim, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP