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Completed

NCT Number: NCT02632227

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

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.

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Key information

Conditions

Fluid Responsiveness

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul national university hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TFU(transfontanel ultrasound)

Procedure

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.)

Primary outcomes

  1. change in respiratory variation of carotid artery blood flow peak velocity after volume expansion

    Time frame: before and after fluid administration (20min)

Secondary outcomes

  1. change in cardiac index after volume expansion

    Time frame: before and after fluid administration (20min)

  2. change in pleth variability index after volume expansion

    Time frame: before and after fluid administration (20min)

  3. change in respiratory variation of aorta flow blood flow peak velocity after volume expansion

    Time frame: before and after fluid administration (20min)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 16, 2015
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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