Cardiac Output Measurement by TEE

NCT03349970 | Unknown

• 1 other identifier: 16-6341
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

Transesophageal echocardiography (TEE) has become a standard monitoring tool during cardiac surgery. It allows continuous accurate assessment of heart structures and function without interfering with the surgery and the anesthetics. The imaging of cardiac structures is used to direct optimal surgical intervention and assess surgical results. Cardiac output (CO) is the result of stroke volume (SV) multiplied by the heart rate. Measurement of cardiac output (CO) is used to quantify the performance of the left ventricle. It is commonly achieved using a pulmonary artery catheter (PAC) (also known ad Swann-Ganz catheter). A known amount of saline solution is injected in the proximal part of the catheter and the variation of blood temperature detected at the tip. Cardiac output is measured based on the duration and degree of temperature change. This method remains an accepted gold standard. TEE allows measurement of cardiac output using a number of different 2D and 3D imaging modalities. Although current guidelines identify the Method of the Disks(MOD) as the gold standard other technique could potentially be more precise. In this study, the investigators want to assess the accuracy of four different TEE methods to measure cardiac output compared with Thermodilution as a standard of care.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• The primary Objective is to compare five different intraoperative echocardiographic measurements of cardiac output with the gold standard thermodilution in patients undergoing elective cardiac surgery.

  Intraoperatively

Secondary Outcomes (1)

• The secondary objective is to test each TEE method against the standard of care method of the disks

  Intraoperatively

Study Arms (1)

TEE vs PAC

we will compare the SV measurements obtained by PAC thermodilution technique to those obtained by different TEE methods in 60 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve (AV) or aortic surgery with cardiopulmonary bypass (CPB) in 2 different cardiac centres. The LV cardiac deformation, expressed as global longitudinal strain (GLS) will be calculated off-line from the acquired images. We will also determine the intra and inter-observer reproducibility of each TEE method.

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

Cardiac patients undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB

You may qualify if:

• age \>18
• undergoing elective CABG, AV or aortic surgery (aortic root and ascending aortic arch surgery), with CPB.

You may not qualify if:

• Emergency surgery
• Moderate or severe valve pathology
• Atrial fibrillation
• Patients with known contraindications to either the insertion of a PAC or the use of TEE.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Toronto General Hopsital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Massimiliano Meineri, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: August 1, 2017
• Primary Completion: May 5, 2018
• Study Completion: December 1, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)