Masimo O3 Regional Oximetry Device in Pediatric Patients Undergoing Cardiac Surgery

Not Applicable

Completed

• Conditions: Pediatric Cardiac Surgery
• Interventions: Device: Masimo O3

• Registration Number: NCT04208906
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Study Start: 2020-01-16
• Primary Completion: 2021-09-30
• Status Verified: 2021-10
• Study Completion: 2021-10-05
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• children under 7 years old

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with congenital cardiac disease	Masimo O3	Pediatric patients aged \< 7 years undergoing cardiac surgery

Primary Outcome Measures

Name	Time	Method
Validation of Masimo O3 value	During surgery	Comparison of ScO2 and StO2 to reference level (SvO2, 0.7×SvO2 + 0.3×SaO2)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Other, Korea, Republic of