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NCT02632227 Clinical Trial

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

Fluid Responsiveness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02632227
Other study ID # 1511-105-0724
Secondary ID
Status Completed
Phase
First received December 13, 2015
Last updated April 4, 2018
Start date December 2015
Est. completion date October 2017

Study information
Verified date April 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Year
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.)

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 change in respiratory variation of carotid artery blood flow peak velocity after volume expansion before and after fluid administration (20min)
Secondary change in cardiac index after volume expansion before and after fluid administration (20min)
Secondary change in pleth variability index after volume expansion before and after fluid administration (20min)
Secondary change in respiratory variation of aorta flow blood flow peak velocity after volume expansion before and after fluid administration (20min)
See also
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Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A