Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
NCT ID: NCT04208906
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-01-16
2021-10-05
Brief Summary
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In addition, we compared the sCO2 and sTO2 with reference value which is calculated using SvO2 and SaO2.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Children with congenital cardiac disease
Pediatric patients aged \< 7 years undergoing cardiac surgery
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Skin disease at sensor attachment site
* Single ventricle physiology
6 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Principal Investigators
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Jin-Tae Kim
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Other, South Korea
Countries
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References
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Lee JH, Song IS, Kang P, Ji SH, Jang YE, Kim EH, Kim HS, Kim JT. Validation of the Masimo O3 regional oximetry device in pediatric patients undergoing cardiac surgery. J Clin Monit Comput. 2022 Dec;36(6):1703-1709. doi: 10.1007/s10877-022-00815-3. Epub 2022 Feb 15.
Other Identifiers
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H1911-099-1081
Identifier Type: -
Identifier Source: org_study_id