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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04208906
Other study ID # H1911-099-1081
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2020
Est. completion date October 5, 2021

Study information

Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 5, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria: - children under 7 years old Exclusion Criteria: - Hyperbilirubinemia - Skin disease at sensor attachment site - Single ventricle physiology

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Other

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validation of Masimo O3 value Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2) During surgery
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