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

NCT01734174 | Withdrawn

• 1 other identifier: 1207012636
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

3D Transesophageal and Transthoracic Echocardiogram

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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); Procedure: thermodilution; Procedure: transthoracic echocardiography (TTE)

Interventions

transesophageal echocardiography (TEE) PROCEDURE

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.

cardiac patients

thermodilution PROCEDURE

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.

cardiac patients

transthoracic echocardiography (TTE) PROCEDURE

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.

cardiac patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Qualified echocardiographer absent or unavailable.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Thermodilution

Intervention Hierarchy (Ancestors)

Indicator Dilution Techniques; Investigative Techniques

Study Officials

• Meghann Fitzgerald, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

US (1)