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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01996956
Enrollment
30
Registered
2013-11-27
Start date
2013-05-31
Completion date
2013-10-31
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness

Keywords

stroke volume variation,, cardiac output,, fluid responsiveness,, noninvasive cardiac output monitor

Brief summary

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.

Interventions

fluid loading of 10 ml/kg colloid or blood product

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
stroke volume indexbefore 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.

Secondary

MeasureTime frameDescription
Cardiac indexbefore 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026