Assement of Left Ventricular Function Before Decannulation in Cardiac Surgery :Visual Estimation vs TEE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Intraoperative Left Ventricular Function Assessment
Diagnostic testLeft 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: Cardiopulmonary Bypass Cohort1 intervention
Trial outcomes
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.
Time frame
During the decannulation phase of cardiopulmonary bypass (intraoperative period)Secondary outcomes
1
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)2
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 postoperatively3
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 bypassSponsors and contacts
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Source ClinicalTrials.gov