NCT06715371

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jan 2025Jun 2026

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 27, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 3, 2025

Status Verified

November 1, 2024

Enrollment Period

1.1 years

First QC Date

November 28, 2024

Last Update Submit

July 2, 2025

Conditions

Keywords

Cardiac ImagingCardiac Chamber DimensionsGeneral AnesthesiaCardiac SurgeryImaging AgreementDiagnostic AccuracyPerioperative CareEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Correlation between preoperative TTE and intraoperative TEE measurements

    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 Outcomes (3)

  • Impact of general anesthesia on correlation between TTE and TEE.

    Within 2 weeks prior to surgery and during surgery

  • Impact of PEEP on correlation between TTE and TEE

    Within 2 weeks prior to surgery and during surgery

  • Impact of cardiac conditions on correlation between TTE and TEE.

    Within 2 weeks prior to surgery and during surgery

Study Arms (1)

Cardiac Surgery Patients

Patients undergoing cardiac surgery (eg., coronary revascularization) at Sunnybrook Health Sciences Centre.

Diagnostic Test: Transthoracic Echocardiography (TTE) and Transesophageal Echocardiography (TEE)

Interventions

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.

Also known as: Transthoracic Echocardiography (TTE), Transesophageal Echocardiography (TEE)
Cardiac Surgery Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective cardiac surgery, specifically coronary revascularization procedures.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (9)

  • 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.

    PMID: 20734448BACKGROUND
  • 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.

    PMID: 16343160BACKGROUND
  • 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.

    PMID: 18835821BACKGROUND
  • 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.

    PMID: 11836489BACKGROUND
  • 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.

    PMID: 36399180BACKGROUND
  • 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.

    PMID: 11580777BACKGROUND
  • 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.

    PMID: 7640014BACKGROUND
  • 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.

    PMID: 32762909BACKGROUND
  • 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.

    PMID: 35340714BACKGROUND

MeSH Terms

Interventions

EchocardiographyEchocardiography, Transesophageal

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Jacobo Moreno Garijo, MD, PhD

    Sunnybrook Health Science Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacobo Moreno Garijo, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

January 27, 2025

Primary Completion

March 2, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

De-identified participant-level data will be made available upon reasonable request to study PI following publication of full trial results.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available following publication of the full trial results.
Access Criteria
Data and supporting information will be made available following reasonable request directly to study PI.

Locations