Assement of Left Ventricular Function Before Decannulation in Cardiac Surgery :Visual Estimation vs TEE

NCT07286227 | Not Yet Recruiting

• 1 other identifier: B.30.2.ata.0.01.00/767
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the diagnostic performance of the cardiovascular surgeon's visual estimation of LV function before decannulation following cardiopulmonary bypass, using TEE results as the reference standard.

Conditions

Cardiopulmonary Bypass Surgery; Left Ventricular Dysfunction

Keywords

Transesophageal Echocardiography; Left Ventricular Ejection Fraction; Visual Estimation; Eyeballing Method; Cardiac Surgery; Ejection Fraction Assessment; Intraoperative Monitoring; Decannulation; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction

  This outcome evaluates the level of agreement between the cardiac surgeon's visual estimation (eyeballing) of left ventricular systolic function and the ejection fraction measured by intraoperative transesophageal echocardiography (TEE). Agreement will be quantified using statistical measures such as Cohen's kappa coefficient and correlation coefficients. Visual estimation categories (e.g., normal, moderately reduced, severely reduced) will be compared with corresponding TEE-derived EF classifications.

  During the decannulation phase of cardiopulmonary bypass (intraoperative period)

Secondary Outcomes (3)

• Diagnostic Accuracy of Surgeon Visual Estimation for Detecting Reduced Left Ventricular Function

  During the decannulation phase of cardiopulmonary bypass (intraoperative period)

• Prediction of Postoperative Hemodynamic Support Requirement

  From intraoperative decannulation through 24 hours postoperatively

• Correlation Between Quantitative TEE Measurements and Surgeon Visual Estimation

  During the decannulation phase of cardiopulmonary bypass

Study Arms (1)

Cardiopulmonary Bypass Cohort

Patients undergoing elective cardiac surgery with cardiopulmonary bypass (CABG, valve surgery, or aortic procedures). During the decannulation phase, left ventricular function will be assessed visually by the cardiac surgeon (eyeballing method) and objectively by intraoperative transesophageal echocardiography (TEE). No additional intervention is performed. Both evaluations are part of standard intraoperative monitoring. Data will be recorded simultaneously to compare the accuracy and agreement between visual estimation and TEE-derived ejection fraction.

Diagnostic Test: Intraoperative Left Ventricular Function Assessment

Interventions

Intraoperative Left Ventricular Function Assessment DIAGNOSTIC_TEST

Left ventricular function will be assessed during the decannulation phase of cardiopulmonary bypass using two diagnostic methods: (1) visual estimation of ventricular contractility by the cardiac surgeon (eyeballing) and (2) objective measurement using intraoperative transesophageal echocardiography (TEE). No experimental procedure, medication, or additional intervention will be applied. Both assessments are part of standard intraoperative monitoring in cardiac surgery. Data from both methods will be collected simultaneously to compare accuracy, agreement, and diagnostic performance.

Also known as: Visual Estimation (Eyeballing), Transesophageal Echocardiography (TEE)

Cardiopulmonary Bypass Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at a single tertiary university hospital. The study population consists of individuals receiving CABG, valve surgery, or aortic surgery who meet eligibility criteria and undergo routine intraoperative TEE monitoring. Participants represent a typical clinical population of moderate-to-high surgical risk (ASA III-IV).

You may qualify if:

• Age between 18 and 75 years
• Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CABG, valve surgery, or aortic surgery)
• ASA physical status III-IV
• Able and willing to provide written informed consent
• Suitable for intraoperative transesophageal echocardiography (TEE)

You may not qualify if:

• Emergency surgery
• Known severe preoperative left ventricular dysfunction (EF \< 30%)
• Significant arrhythmias (e.g., atrial fibrillation)
• Preoperative requirement for mechanical circulatory support (e.g., IABP)
• Contraindications to TEE (esophageal pathology, bleeding risk, strictures)
• Inability to provide informed consent

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

Location

Related Publications (4)

• Kim H. Weaning from cardiopulmonary bypass. Korean J Anesthesiol. 2013 Jun;64(6):487-8. doi: 10.4097/kjae.2013.64.6.487. No abstract available.

  PMID: 23814646 BACKGROUND

• Abazid RM, Abohamr SI, Smettei OA, Qasem MS, Suresh AR, Al Harbi MF, Aljaber AN, Al Motairy AA, Albiela DE, Almutairi BM, Sakr H. Visual versus fully automated assessment of left ventricular ejection fraction. Avicenna J Med. 2018 Apr-Jun;8(2):41-45. doi: 10.4103/ajm.AJM_209_17.

  PMID: 29682476 BACKGROUND

• Metkus TS, Thibault D, Grant MC, Badhwar V, Jacobs JP, Lawton J, O'Brien SM, Thourani V, Wegermann ZK, Zwischenberger B, Higgins R. Transesophageal Echocardiography in Patients Undergoing Coronary Artery Bypass Graft Surgery. J Am Coll Cardiol. 2021 Jul 13;78(2):112-122. doi: 10.1016/j.jacc.2021.04.064. Epub 2021 May 3.

  PMID: 33957241 BACKGROUND

• Bayram E, Gulcu O, Aksu U, Aksakal E, Birdal O, Kalkan K. Evaluating the Association Between the Three Different Ejection Fraction Measurement Techniques and Left Ventricle Global Strain. Eurasian J Med. 2018 Oct;50(3):173-177. doi: 10.5152/eurasianjmed.2018.17409.

  PMID: 30515038 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Muhammed Enes Aydın, Principal Investigator

  Ataturk University Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed Enes Aydin, Associate Professor

CONTACT

+90-554-331-82-89; enesmd@msn.com

Filiz Albayrak, assistant doctor

CONTACT

+90-545-226-98-49; zlfalbyrk@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOÇENT.DR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

TU (1)