Prediction of Fluid Responsiveness by NICOM (Non-invasive Cardiac Output Monitoring) in Children With Congenital Heart Disease After Cardiac Surgery

November 21, 2013 updated by: Jin-Tae Kim, Seoul National University Hospital
The purpose of this study is to evaluate the ability of fluid responsiveness by stroke volume variation value of NICOM(Noninvasive cardiac output monitor)system during congenital cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

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

1 day to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • congenital cardiac surgery
  • < 6 years old
  • who were required the evaluation by transesophageal echocardiography

Exclusion Criteria:

  • right heart failure
  • supported by more than 2 inotropic agents
  • reduced kidney function
  • any valvar stenosis
  • moderate or severe tricuspid regurgitation
  • single ventricle

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Volume loading
Other: volume expansion
fluid loading of 10 ml/kg colloid or blood product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke volume index
Time Frame: before and after volume loading (20 min)
Volume loading was performed for 20 minutes. Stroke volume measured before and after volume expansion using transesophageal echocardiography. And, stroke volume variation of NICOM monitor was recorded before fluid loading.
before and after volume loading (20 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac index
Time Frame: before and after fluid loading (20 min)
Cardiac index measured by transesophageal echocardiography and NICOM monitor were compared before and after fluid loading for 20 min.
before and after fluid loading (20 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Jin-Tae Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 17, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1303-114-478

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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