- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06715371
Comparing Cardiac Chamber Measurements: TTE vs. TEE Under Anesthesia (CM-TTE-TEE)
Reassessing Normative Cardiac Chamber Measurements: A Comparative Study of TTE and TEE Under General Anesthesia.
This study aims to compare two common ultrasound techniques used during heart surgery: transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE). TTE is performed by placing an ultrasound probe on the chest, while TEE involves inserting a probe into the esophagus, which provides closer and clearer images of the heart. Both methods are part of routine care for patients undergoing heart surgery.
The goal of this study is to assess how well the measurements from TTE and TEE agree in evaluating heart chamber dimensions during surgery and to investigate how factors such as anesthesia, breathing techniques affect these measurements.
This research involves 114 adult patients scheduled for heart surgery at Sunnybrook Health Sciences Centre. Participants will have TTE performed before and after surgery, and TEE will be conducted during surgery. All procedures are part of the usual standard of care.
By comparing these imaging techniques, the study seeks to provide more accurate and up-to-date guidelines for cardiac measurements, ensuring better care for patients during heart surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This observational study compares transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) in measuring cardiac chamber dimensions in adult patients undergoing cardiac surgery. While both techniques are integral to clinical care, TEE is typically used intraoperatively for its superior image quality, and TTE is performed preoperatively as a non-invasive diagnostic tool. However, differences in measurement values between TTE and TEE, particularly under the physiological changes induced by general anesthesia and positive end-expiratory pressure (PEEP), remain poorly understood. This study seeks to address this gap and update normative cardiac measurement values.
Study Design: A prospective observational study enrolling patients scheduled for coronary revascularization surgery at Sunnybrook Health Sciences Centre (n=114). All imaging procedures are part of routine clinical care.
Primary Objective: To evaluate the agreement between preoperative TTE and intraoperative TEE measurements of cardiac chamber dimensions.
Secondary Objectives:
- To explore how physiological changes from general anesthesia and PEEP impact the correlation between TTE and TEE measurements.
- To analyze how pre-existing cardiac conditions (e.g., hypertension, diabetes, atrial fibrillation) affect the agreement between these modalities.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lilia Kaustov, PhD
- Phone Number: 89607 416-480-6100
- Email: lilia.kaustov@sunnybrook.ca
Study Contact Backup
- Name: Jacobo Moreno Garijo, MD, PhD
- Phone Number: 416-480-4864
- Email: jacobo.morenogarijo@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Lilia Kaustov, PhD
- Phone Number: 89607 416-480-6100
- Email: lilia.kaustov@sunnybrook.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18, able to provide informed consent.
- Patients scheduled for coronary revascularization cardiac surgery under general anesthesia.
- With normal left ventricular (LV) systolic function, defined by an ejection fraction of 50% or more, and normal right ventricular (RV) systolic function.
- Requiring intraoperative echocardiographic assessment.
Exclusion Criteria:
- Patients with contraindications to either transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).
- History of poor-quality echocardiography data that preclude accurate assessment.
- Undergoing emergency cardiac surgery.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cardiac Surgery Patients
Patients undergoing cardiac surgery (eg., coronary revascularization) at Sunnybrook Health Sciences Centre.
|
Transthoracic echocardiography (TTE) is a non-invasive imaging technique performed by placing an ultrasound transducer on the chest to obtain detailed heart images. TTE is conducted preoperatively on awake patients within two weeks prior to cardiac surgery, following ASE chamber quantification guidelines. Transesophageal echocardiography (TEE) is an invasive imaging technique where an ultrasound transducer is placed in the esophagus, providing closer and clearer images of the heart. TEE is performed intraoperatively under general anesthesia as part of routine care.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between preoperative TTE and intraoperative TEE measurements
Time Frame: Within 2 weeks prior to surgery and during surgery
|
The correlation between preoperative transthoracic echocardiography (TTE) and intraoperative transesophageal echocardiography (TEE) measurements of cardiac chamber dimensions, including left ventricular internal dimensions, left atrial volume, and right atrial dimensions.
|
Within 2 weeks prior to surgery and during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of general anesthesia on correlation between TTE and TEE.
Time Frame: Within 2 weeks prior to surgery and during surgery
|
Impact of physiological changes induced by general anesthesia on the correlation between TTE and TEE measurements.
|
Within 2 weeks prior to surgery and during surgery
|
|
Impact of PEEP on correlation between TTE and TEE
Time Frame: Within 2 weeks prior to surgery and during surgery
|
Impact of physiological changes induced by PEEP on the correlation between TTE and TEE measurements.
|
Within 2 weeks prior to surgery and during surgery
|
|
Impact of cardiac conditions on correlation between TTE and TEE.
Time Frame: Within 2 weeks prior to surgery and during surgery
|
Impact of cardiac conditions (e.g., COPD, hypertension, history of atrial fibrillation) on the correlation between TTE and TEE measurements.
|
Within 2 weeks prior to surgery and during surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacobo Moreno Garijo, MD, PhD, Sunnybrook Health Science Centre
Publications and helpful links
General Publications
- Teran F, Prats MI, Nelson BP, Kessler R, Blaivas M, Peberdy MA, Shillcutt SK, Arntfield RT, Bahner D. Focused Transesophageal Echocardiography During Cardiac Arrest Resuscitation: JACC Review Topic of the Week. J Am Coll Cardiol. 2020 Aug 11;76(6):745-754. doi: 10.1016/j.jacc.2020.05.074.
- Kabirdas D, Scridon C, Brenes JC, Hernandez AV, Novaro GM, Asher CR. Accuracy of transthoracic echocardiography for the measurement of the ascending aorta: comparison with transesophageal echocardiography. Clin Cardiol. 2010 Aug;33(8):502-7. doi: 10.1002/clc.20807.
- Singh H, Jain AC, Bhumbla DK, Failinger C. Comparison of left atrial dimensions by transesophageal and transthoracic echocardiography. Echocardiography. 2005 Nov;22(10):789-96. doi: 10.1111/j.1540-8175.2005.00128.x.
- Shiran A, Adawi S, Ganaeem M, Asmer E. Accuracy and reproducibility of left ventricular outflow tract diameter measurement using transthoracic when compared with transesophageal echocardiography in systole and diastole. Eur J Echocardiogr. 2009 Mar;10(2):319-24. doi: 10.1093/ejechocard/jen254. Epub 2008 Oct 2.
- Block M, Hourigan L, Bellows WH, Reeves J 3rd, Romson JL, Tran M, Pastor D, Schiller NB, Leung JM. Comparison of left atrial dimensions by transesophageal and transthoracic echocardiography. J Am Soc Echocardiogr. 2002 Feb;15(2):143-9. doi: 10.1067/mje.2002.121399.
- Assanangkornchai N, Villeneuve V, McDonald S, Magder S, Shum Tim D, Buithieu J, Hatzakorzian R. Interchangeability of transthoracic and transesophageal echocardiographic right heart measurements in the perioperative setting and correlation with hemodynamic parameters. Int J Cardiovasc Imaging. 2023 Mar;39(3):555-563. doi: 10.1007/s10554-022-02754-1. Epub 2022 Nov 18.
- Skarvan K, Lambert A, Filipovic M, Seeberger M. Reference values for left ventricular function in subjects under general anaesthesia and controlled ventilation assessed by two-dimensional transoesophageal echocardiography. Eur J Anaesthesiol. 2001 Nov;18(11):713-22. doi: 10.1046/j.1365-2346.2001.00915.x.
- Cohen GI, White M, Sochowski RA, Klein AL, Bridge PD, Stewart WJ, Chan KL. Reference values for normal adult transesophageal echocardiographic measurements. J Am Soc Echocardiogr. 1995 May-Jun;8(3):221-30. doi: 10.1016/s0894-7317(05)80031-8.
- Giron-Arango L, D'Empaire PP. Is There a Role for Transesophageal Echocardiography in the Perioperative Trauma Patient? Curr Anesthesiol Rep. 2022;12(2):210-216. doi: 10.1007/s40140-022-00526-0. Epub 2022 Mar 19.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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