NCT03156764

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

May 10, 2017

Last Update Submit

March 15, 2021

Conditions

Anesthesia, GeneralCongenital Heart DiseaseBlood Gas Monitoring, TranscutaneousBlood Gas Analysis

Keywords

Qp/Qs ratioPediatric congenital heart disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • the difference between SpO2 and SaO2

    within 1 week after surgery

  • the difference between cerebral oximeter score and and SmvO2

    within 1 week after surgery

Study Arms (1)

Qp/Qs ratio monitoring

Qp/Qs ratio monitoring

Other: Qp/Qs ratio monitoring

Interventions

Qp/Qs ratio monitoringOTHER

Op/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA

Qp/Qs ratio monitoring

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • pediatric cardiac patients scheduled to cardiac operation (shunt dependent pulmonary circulation)
  • preoperative SpO2\<97%

You may not qualify if:

  • unable to measure pulse oximeter or cerebral oximeter signal
  • unable to measure SaO2 or SmvO2
  • unstable vital sign

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2017

First Posted

May 17, 2017

Study Start

May 23, 2017

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

KR(1)