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

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.

Study Overview

• Status: Withdrawn
• Conditions: 3D Transesophageal and Transthoracic Echocardiogram
• Intervention / Treatment: Procedure: transesophageal echocardiography (TEE); Procedure: thermodilution; Procedure: transthoracic echocardiography (TTE)

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

cardiac patients; 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.

Procedure: transesophageal echocardiography (TEE); 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.; Procedure: thermodilution; 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.; Procedure: transthoracic echocardiography (TTE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General heart function (Left ventricular volume and ejection fraction)	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.	During cardiac surgery

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Meghann Fitzgerald, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: thermodilution; transesophageal and transthoracic echocardiogram; left ventricular volume; ejection volume
• Other Study ID Numbers: 1207012636