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

March 15, 2021 updated by: Jin-Tae Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Qp/Qs ratio monitoring
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference between Qp/Qs-monitor and Qp/Qs-blood
Time Frame: 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)
within 1 week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the difference between SpO2 and SaO2
Time Frame: within 1 week after surgery
the difference between SpO2 (measure by pulse oximeter)and SaO2 (measured by blood gas analysis)
within 1 week after surgery
the difference between cerebral oximeter score and and SmvO2
Time Frame: within 1 week after surgery
the difference between cerebral oximeter (measure by NIRS)and SmvO2 (measured by blood gas analysis)
within 1 week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

July 21, 2020

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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