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Correlation of Estimated Continuous Cardiac Output (esCCO) and TEE in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01865994
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Nihon Kohden Europe
Information provided by (Responsible Party):
Christoph Schramm, M.D., Heidelberg University

Brief Summary:
The purpose of this study is to determine the measuring accuracy of the truly non-invasive method estimated continuous cardiac output (esCCO) against the reference method transesophageal echocardiography in pediatric cardiac surgery. esCCO is calculated using the pulse wave transit time, which is defined as the time between the R-wave of the ECG and the 30% increase of the differentiated pulseoximetry waveform.

Condition or disease
Cardiac Diseases Requiring Surgery

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.


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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study to Examine the Correlation of 'Estimated Continuous Cardiac Output' (esCCO) With Transesophageal Echocardiography (TEE) in Pediatric Cardiac Surgery
Study Start Date : August 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort
Pediatric cardiac surgery
Children scheduled for elective cardiac surgery



Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: Intraoperative ]
    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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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients (0-18 yrs) scheduled for elective cardiac surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865994


Locations
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Germany
University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Nihon Kohden Europe

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Responsible Party: Christoph Schramm, M.D., Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT01865994     History of Changes
Other Study ID Numbers: S108/2012
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Christoph Schramm, M.D., Heidelberg University:
Cardiac Output
esCCO
TEE
Pediatric cardiac surgery
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases