Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT04208906|
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : March 26, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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)
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.
- Validation of Masimo O3 value [ Time Frame: During surgery ]Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)
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
|Contact: Jin-Tae Kimfirstname.lastname@example.org|
|Contact: Ji-Hyun Leeemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Other, Korea, Republic of, 03080|
|Contact: Ji-Hyun Lee 01076658848|
|Principal Investigator:||Jin-Tae Kim||Seoul National University Hospital|