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Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

NCT04208906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-25

No results posted yet for this study

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.

Conditions

  • Pediatric Cardiac Surgery

Interventions

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jin-Tae Kim · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-09-30
Completion
2021-10-05

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04208906 on ClinicalTrials.gov