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Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01734174
Enrollment
0
Registered
2012-11-27
Start date
2012-09-30
Completion date
2013-11-30
Last updated
2018-06-28

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

Conditions

3D Transesophageal and Transthoracic Echocardiogram

Keywords

transesophageal and transthoracic echocardiogram, thermodilution, left ventricular volume, ejection volume

Brief summary

Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and through the chest wall; both TEE and TTE are performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery. The purpose of the study is to compare these two methods of echocardiography and comparing them to the 2D TEE and TTE assessments, which are routinely performed simultaneously. The study will also compare the echocardiography data to a third technique, thermodilution, which measures cardiac function via a pulmonary artery catheter.

Interventions

Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.

PROCEDUREthermodilution

A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other.

Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries. * 18 years or older

Exclusion criteria

for thermodilution assessment are as follows: * Moderate to severe tricuspid regurgitation * Contraindications to pulmonary artery catheter placement based on the American Society of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization.

Design outcomes

Primary

MeasureTime frameDescription
General heart function (Left ventricular volume and ejection fraction)During cardiac surgeryLeft ventricular volume will be assessed by 3-dimensional transesophageal echocardiography (3D TEE) and compared to data from 3-dimensional transthoracic echocardiography (3D TTE). 3D measurements will be compared to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, this assessment will be compared to a third method of quantification of cardiac function via a pulmonary artery catheter.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026