Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease

April 4, 2018 updated by: Jin-Tae Kim, Seoul National University Hospital

Prediction of Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease After Cardiac Surgery

The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

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 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

pediatric patients with congenital heart disease undergoing cardiac surgery

Description

Inclusion Criteria:

  • pediatric patients undergoing cardiac surgery

Exclusion Criteria:

  • preterm closure of anterior fontanelle
  • anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
  • presence of intracardiac and extracardiac shunt

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypovolemia
patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output
Procedure: TFU(transfontanel ultrasound)
The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in respiratory variation of carotid artery blood flow peak velocity after volume expansion
Time Frame: before and after fluid administration (20min)
before and after fluid administration (20min)

Secondary Outcome Measures

Outcome Measure
Time Frame
change in cardiac index after volume expansion
Time Frame: before and after fluid administration (20min)
before and after fluid administration (20min)
change in pleth variability index after volume expansion
Time Frame: before and after fluid administration (20min)
before and after fluid administration (20min)
change in respiratory variation of aorta flow blood flow peak velocity after volume expansion
Time Frame: before and after fluid administration (20min)
before and after fluid administration (20min)

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

December 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 13, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1511-105-0724

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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