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

Completed

• Conditions: Fluid Responsiveness
• Interventions: Procedure: TFU(transfontanel ultrasound)

• Registration Number: NCT02632227
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-13
• Study First Submitted QC: 2015-12-13
• Study First Posted: 2015-12-16
• Primary Completion: 2017-03
• Study Completion: 2017-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• pediatric patients undergoing cardiac surgery

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypovolemia	TFU(transfontanel ultrasound)	patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output

Primary Outcome Measures

Name	Time	Method
change in respiratory variation of carotid artery blood flow peak velocity after volume expansion	before and after fluid administration (20min)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of