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

Withdrawn

• Conditions: 3D Transesophageal and Transthoracic Echocardiogram
• Interventions: Procedure: transesophageal echocardiography (TEE); Procedure: thermodilution; Procedure: transthoracic echocardiography (TTE)

• Registration Number: NCT01734174
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-27
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion criteria for performance of TEE:

• Contraindications to the performance of TEE based on the Journal of the American Society of Echocardiologists' 2011 recommendations and the American Society of Anesthesiologist Guidelines for Performance of Perioperative Transesophageal Echocardiography.
• Any degree of mitral regurgitation or aortic insufficiency above trace.

Exclusion criteria for performance of TTE, both 3D and 2D:

• Qualified echocardiographer absent or unavailable.

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiac patients	transesophageal echocardiography (TEE)	Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.
cardiac patients	thermodilution	Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.
cardiac patients	transthoracic echocardiography (TTE)	Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries will be recruited for this study to validate measurements of left ventricular volume and ejection fraction (a quantitative measure of general heart function) as assessed by 3-dimensional transesophageal echocardiography (3D TEE) as compared to 3-dimensional transthoracic echocardiography (3D TTE). Secondarily, we will also compare the 3D TEE assessment to the 2D TEE and TTE assessment, which is routinely performed simultaneously. Last, we will compare this assessment to a third method of quantification of cardiac function via a pulmonary artery catheter using thermodilution.

Primary Outcome Measures

Name	Time	Method
General heart function (Left ventricular volume and ejection fraction)	During cardiac surgery	Left 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.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States