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

Assessment of Left Ventricular Function Before Decannulation in Cardiopulmonary Bypass Surgeries: Comparison of the Cardiac Surgeon's Visual Estimation and Transesophageal Echocardiography

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Left Ventricular Dysfunction; Cardiopulmonary Bypass Surgery
• Intervention / Treatment: Diagnostic test: Intraoperative Left Ventricular Function Assessment

Detailed Description

The fundamental rationale for conducting this study is that the moment of decannulation after cardiopulmonary bypass (CPB) represents one of the most critical stages in cardiac surgery in terms of patient outcomes. At this stage, inadequate left ventricular (LV) function (dysfunction) can lead to severe hemodynamic deterioration, increased complications, and a higher risk of mortality. Therefore, accurately and rapidly assessing LV function just before separation from CPB is of vital importance. Although Transesophageal Echocardiography (TEE) is currently the most reliable and objective method, it requires specialized equipment, training, and time. On the other hand, experienced cardiac surgeons often make a visual estimation based on the observable physical appearance of the heart (such as its color, contractility, and fullness), relying on their many years of experience. This visual assessment is extremely fast and practical; however, it is subjective, and its reliability has not been clearly established scientifically.

Thus, the primary rationale for this study is to fill this gap in the scientific literature and determine how well the surgeon's quick, experience-based visual estimation aligns with the objective findings of TEE, the gold-standard method.

The main objective of the study is 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. In other words, it aims to statistically determine the agreement between the surgeon's practical visual assessment and the objective measurements provided by TEE, thereby offering a scientific basis for clinical decision-making by revealing the sensitivity and specificity limits of the surgeon's estimation, particularly in detecting critical conditions such as severe dysfunction.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Muhammed Enes Aydin, Associate Professor; Phone Number: +90-554-331-82-89; Email: enesmd@msn.com
• Study Contact Backup: Name: Filiz Albayrak, assistant doctor; Phone Number: +90-545-226-98-49; Email: zlfalbyrk@gmail.com

Study Locations

• Turkey (Türkiye)
  • Erzurum, Turkey (Türkiye), 25000
    • Ataturk University
    • Contact: Filiz Albayrak, assistant doctor; Phone Number: +90-545-226-98-49; Email: zlfalbyrk@gmail.com
    • Contact: Muhammed Enes Aydin, doctor; Phone Number: +90-554-331-82-89; Email: enesmd@msn.com
    • Sub-Investigator: Filiz Albayrak, assistant doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other Names: Transesophageal Echocardiography (TEE); Visual Estimation (Eyeballing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Accuracy of Surgeon Visual Estimation for Detecting Reduced Left Ventricular Function	This outcome measures the diagnostic performance of the surgeon's visual estimation in identifying reduced left ventricular systolic function, using TEE-derived ejection fraction as the reference standard. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy will be calculated for detecting clinically significant systolic dysfunction (e.g., EF < 30% or EF < 40%).	During the decannulation phase of cardiopulmonary bypass (intraoperative period)
Prediction of Postoperative Hemodynamic Support Requirement	This outcome evaluates whether the surgeon's intraoperative visual assessment of left ventricular function predicts the need for postoperative hemodynamic support. Outcomes include the requirement for intra-aortic balloon pump (IABP), return to cardiopulmonary bypass, or initiation of high-dose inotropic therapy during or after separation from bypass.	From intraoperative decannulation through 24 hours postoperatively
Correlation Between Quantitative TEE Measurements and Surgeon Visual Estimation	This outcome examines the correlation between TEE-derived quantitative parameters (ejection fraction, end-diastolic volume, end-systolic volume) and the categorical visual estimation provided by the cardiac surgeon (normal, moderately reduced, severely reduced). Correlation coefficients (Pearson or Spearman) will be calculated.	During the decannulation phase of cardiopulmonary bypass

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Principal Investigator: Muhammed Enes Aydın, Principal Investigator, Ataturk University Department of Anesthesiology and Reanimation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Cardiopulmonary Bypass; Decannulation; Transesophageal Echocardiography; Left Ventricular Ejection Fraction; Intraoperative Monitoring; Visual Estimation; Eyeballing Method; Ejection Fraction Assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Left; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Echocardiography; Cardiac Imaging Techniques; Ultrasonography; Echocardiography, Transesophageal
• Other Study ID Numbers: B.30.2.ata.0.01.00/767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The decision regarding IPD sharing has not yet been finalized. If data sharing is pursued in the future, it will involve de-identified datasets and will comply with institutional and ethical regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No