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NCT Number: NCT07286227

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Visual Estimation (Eyeballing), Transesophageal Echocardiography (TEE)

Primary outcomes

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

    Time frame: During the decannulation phase of cardiopulmonary bypass (intraoperative period)

    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.

Secondary outcomes

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

    Time frame: During the decannulation phase of cardiopulmonary bypass (intraoperative period)

    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%).

  2. Prediction of Postoperative Hemodynamic Support Requirement

    Time frame: From intraoperative decannulation through 24 hours postoperatively

    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.

  3. Correlation Between Quantitative TEE Measurements and Surgeon Visual Estimation

    Time frame: During the decannulation phase of cardiopulmonary bypass

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Filiz Albayrak, assistant doctor

CONTACT

[email protected]

+90-545-226-98-49

Muhammed Enes Aydin, Associate Professor

CONTACT

[email protected]

+90-554-331-82-89

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: LVFuncTee

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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