- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01865994
Correlation of Estimated Continuous Cardiac Output (esCCO) and TEE in Pediatric Cardiac Surgery
Study to Examine the Correlation of 'Estimated Continuous Cardiac Output' (esCCO) With Transesophageal Echocardiography (TEE) in Pediatric Cardiac Surgery
Study Overview
Status
Conditions
Detailed Description
The objective is to compare two methods of cardiac output measurement in children: the new non-invasive method called esCCO™ (by Nihon Kohden, Tokyo, Japan) and the established more invasive method transesophageal echocardiography (TEE). esCCO™ is a completely non-invasive method that could provide a cardiac output measurement in a large range of pediatric patients because of an extremely low risk benefit balance.
Cardiac output monitoring has been technically challenging in pediatric patients. Available methods for measuring cardiac output in children are either inaccurate or highly invasive or limited to a small number of patients. So far esCCO™ has not been tested in the pediatric population but showed promising results when it was tested against the pulmonary artery catheter in adult patients undergoing heart surgery in previous Japanese studies.
Thus the validity of esCCO™ is now tested in pediatric patients scheduled for elective cardiac surgery. Transesophageal echocardiography has been chosen as reference method because it is performed routinely during pediatric cardiac surgery.
The algorithm for esCCO™ -measurement is integrated in an approved patient monitor that replaces the standard patient monitor during the measurement-period.
In the study protocol, events like esCCO™ -calibration time, catheter positioning time, ventilation settings, volume in- and output and drug administration, patients's data and diagnoses are logged. Vital parameters from the patient monitor including the esCCO™-cardiac output values are recorded every second in real time on a study laptop mounted on the same rack as the patient monitor but electrically separated from the other devices.
EsCCO™ measurements shall be compared to TEE cardiac output measurements at three given times: (1) before surgical intervention, (2) shortly after cardiopulmonary bypass and (3) after closure of the thorax.
A total of 50 patients shall be investigated in the study during a planned study time of approximately 6 months. The ethics committee of the University of Heidelberg gave their consent to the study (S-108/2012). For statistical analysis, a Bland-Altman-test for measurements with multiple values per patient, correlation graphics and a regression equation will be performed.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Heidelberg, Germany, 69120
- University of Heidelberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- written consent
- children <=18 years
- elective cardiac surgery
- Sinus rhythm
Exclusion Criteria:
- no written consent
- continuous severe cardiac arrhythmias
- cardiac Pacemaker
- intraaortal balloon pump
- contraindications for TEE
- persistent ductus arteriosus botalli
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Pediatric cardiac surgery
Children scheduled for elective cardiac surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Output
Time Frame: Intraoperative
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EsCCO™ measurements shall be compared to TEE cardiac output measurements at three given times: (1) before surgical intervention, (2) shortly after cardiopulmonary bypass and (3) after closure of the thorax
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Intraoperative
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S108/2012
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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