Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Pediatric Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208906
• Other study ID #: H1911-099-1081
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pediatric Cardiac Surgery

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