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Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04208906
Enrollment
50
Registered
2019-12-23
Start date
2020-01-16
Completion date
2021-10-05
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Cardiac Surgery

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.

Interventions

DEVICEMasimo 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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No

Inclusion criteria

* children under 7 years old

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Validation of Masimo O3 valueDuring surgeryComparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026