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NCT03156764 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Official title:
The Accuracy of Qp/Qs Calculated by Noninvasive Methods in Children With Shunt Dependent Pulmonary Circulation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03156764
Other study ID # 2017-1046
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 23, 2017
Est. completion date July 21, 2020

Study information
Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 29
Est. completion date July 21, 2020
Est. primary completion date July 21, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Qp/Qs ratio monitoring
Op/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

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 the difference between Qp/Qs-monitor and Qp/Qs-blood the difference between Qp/Qs-monitor (measure by pulse oximeter and NIRS) and Qp/Qs-blood (measured by blood gas analysis) within 1 week after surgery
Secondary the difference between SpO2 and SaO2 the difference between SpO2 (measure by pulse oximeter)and SaO2 (measured by blood gas analysis) within 1 week after surgery
Secondary the difference between cerebral oximeter score and and SmvO2 the difference between cerebral oximeter (measure by NIRS)and SmvO2 (measured by blood gas analysis) within 1 week after surgery
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