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Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

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: NCT04208906
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Brief Summary:

We evaluate the relationship between the regional tissue oxygenation value (ScO2 - cerebral, StO2 - lower limb) and mixed venous saturation (SvO2) and arterial oxygen saturation (SaO2) measured before and after correction surgery in pediatric patients undergoing cardiac surgery.

In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.


Condition or disease Intervention/treatment Phase
Pediatric Cardiac Surgery Device: Masimo O3 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Children with congenital cardiac disease
Pediatric patients aged < 7 years undergoing cardiac surgery
Device: Masimo O3

After anesthesia induction, a masimo O3 sensors are attached to the forehead (ScO2) and the sole of the foot (StO2). About 0.4 ml blood samples are obtained from arterial line and central venous line at three epochs before and after cardiopulmonary bypass (total 6 times)

  • T1: before cardiopulmonary bypass (CPB), fraction of inspired oxygen (FiO2) 0.2
  • T2: before CPB, FiO2 0.5
  • T3: before CPB, FiO2 0.8
  • T4: after CPB, FiO2 0.8
  • T5: after CPB, FiO2 0.5
  • T6: after CPB, FiO2 0.2

Hemoglobin oxygen saturation values are confirmed in each sample (arterial sample: SaO2, venous sample: SvO2). Each O3 values (ScO2 and StO2) are compared to the values of SvO2, 0.7 × SvO2 + 0.3 × SaO2.





Primary Outcome Measures :
  1. Validation of Masimo O3 value [ Time Frame: During surgery ]
    Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children under 7 years old

Exclusion Criteria:

  • Hyperbilirubinemia
  • Skin disease at sensor attachment site
  • Single ventricle physiology

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): NCT04208906


Contacts
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Contact: Jin-Tae Kim 82-2-2072-3661 jintae73@gmail.com
Contact: Ji-Hyun Lee 01076658848 muslab@hanmail.net

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Other, Korea, Republic of, 03080
Contact: Ji-Hyun Lee    01076658848      
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim Seoul National University Hospital
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04208906    
Other Study ID Numbers: H1911-099-1081
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: December 2019

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