Qp/Qs Ratio by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation

Terminated

• Conditions: Congenital Heart Disease; Blood Gas Monitoring, Transcutaneous; Anesthesia, General; Blood Gas Analysis
• Interventions: Other: Qp/Qs ratio monitoring

• Registration Number: NCT03156764
• Lead Sponsor: Seoul National University Hospital

Brief Summary

In pediatric cardiac patients with shunt dependent pulmonary circulation, Qp/Qs ratio is a important parameter indicating the balance of pulmonaty and systemic circulation.

This study will calculate Qp/Qs using variables measured using non-invasive monitors (cerebral oximeter and pulse oximeter). This value will be compared with Qp/Qs calculated using variables obtained from blood sample.

Detailed Description

Blood sampling will be performed in both arterial and central venous lines.

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-05-23
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
2. preoperative SpO2<97%

Exclusion Criteria

1. unable to measure pulse oximeter or cerebral oximeter signal
2. unable to measure SaO2 or SmvO2
3. unstable vital sign

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Qp/Qs ratio monitoring	Qp/Qs ratio monitoring	Qp/Qs ratio monitoring

Primary Outcome Measures

Name	Time	Method
the difference between Qp/Qs-monitor and Qp/Qs-blood	within 1 week after surgery	the difference between Qp/Qs-monitor (measure by pulse oximeter and NIRS) and Qp/Qs-blood (measured by blood gas analysis)

Secondary Outcome Measures

Name	Time	Method
the difference between SpO2 and SaO2	within 1 week after surgery	the difference between SpO2 (measure by pulse oximeter)and SaO2 (measured by blood gas analysis)
the difference between cerebral oximeter score and and SmvO2	within 1 week after surgery	the difference between cerebral oximeter (measure by NIRS)and SmvO2 (measured by blood gas analysis)

Trial Locations

Locations (1)

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