An observational study in Cardiopulmonary Bypass Surgery and Left Ventricular Dysfunction, sponsored by Ataturk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Ataturk University · Observational
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.
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.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 70 is below the median of 198 across 103 observational studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
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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).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Visual Estimation (Eyeballing), Transesophageal Echocardiography (TEE)
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.
Time frame: During the decannulation phase of cardiopulmonary bypass (intraoperative period)
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%).
Time frame: 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.
Time frame: 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.
Time frame: During the decannulation phase of cardiopulmonary bypass
Plan to share: Undecided — 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.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
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