Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedStudy Start
First participant enrolled
January 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2021
CompletedOctober 25, 2021
October 1, 2021
1.7 years
December 20, 2019
October 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of Masimo O3 value
Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)
During surgery
Study Arms (1)
Children with congenital cardiac disease
EXPERIMENTALPediatric patients aged \< 7 years undergoing cardiac surgery
Interventions
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
You may qualify if:
- children under 7 years old
You may not qualify if:
- Hyperbilirubinemia
- Skin disease at sensor attachment site
- Single ventricle physiology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Other, 03080, South Korea
Related Publications (1)
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.
PMID: 35169968DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 20, 2019
First Posted
December 23, 2019
Study Start
January 16, 2020
Primary Completion
September 30, 2021
Study Completion
October 5, 2021
Last Updated
October 25, 2021
Record last verified: 2021-10