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NCT01996956 Clinical Trial

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

Fluid Responsiveness Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01996956
Other study ID # H-1303-114-478
Secondary ID
Status Completed
Phase N/A
First received November 17, 2013
Last updated November 21, 2013
Start date May 2013
Est. completion date October 2013

Study information
Verified date November 2013
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• volume expansion
fluid loading of 10 ml/kg colloid or blood product

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 stroke volume index 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) No
Secondary Cardiac index 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) No
See also
  Status Clinical Trial Phase
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Completed NCT03713008 - Assessment Of Carotid Flow During General Anesthesia N/A
Completed NCT02277353 - Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery N/A
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Recruiting NCT04186416 - Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT04574011 - Fluid Responsiveness in Spontaneously Ventilating Patient N/A
Completed NCT01821742 - Echocardiography in Kids Intensive Care Decision Support
Completed NCT04802668 - Factors Influencing of Pulse Pressure Variation (PPV)
Not yet recruiting NCT06254456 - Fluid Responsiveness in Prone Patients N/A
Completed NCT02789124 - Diagnostic Value of Passive Leg Raise Induced Changes in Carotid Artery Flow Time to Predict Fluid Responsiveness in Critically Ill Patients N/A
Completed NCT02040948 - Accuracy of Pulse Pressure Variation and of Pleth Variability Index to Predict the Response to a Fluid Challenge N/A
Withdrawn NCT01898975 - A Gray Zone Approach to Stroke Volume Variation Derived From NICOM N/A
Completed NCT05419570 - Short Time Low PEEP Challenge and Mini Fluid Challenge