CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Masimo O3device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04208906
NCT04208906N/ACompleted
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Validation of Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Seoul National University Hospital·interventional·Posted Dec 23, 2019·Updated Oct 25, 2021

In Brief

A clinical study evaluating Masimo O3 for Pediatric Cardiac Surgery. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediatric Cardiac Surgery
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 23, 2019
Enrollment StartJan 16, 2020
Primary CompletionSep 30, 2021
Study CompletionOct 5, 2021
TodayJul 1, 2026
Enrollment to primary: 1.7 yearsPosted 6.5 years ago

Interventions

Masimo O3device

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.