Ataturk University
Erzurum, 25000, Turkey (Türkiye)
Location contact
Filiz Albayrak, assistant doctor
CONTACT
Filiz Albayrak, assistant doctor
SUB_INVESTIGATOR
Muhammed Enes Aydin, doctor
CONTACT
NCT Number: NCT07286227
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Observational
Erzurum, 25000, Turkey (Türkiye)
Filiz Albayrak, assistant doctor
CONTACT
Filiz Albayrak, assistant doctor
SUB_INVESTIGATOR
Muhammed Enes Aydin, doctor
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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%).
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.
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.
Contact information is provided by the study sponsor or research team.
Filiz Albayrak, assistant doctor
CONTACT
Muhammed Enes Aydin, Associate Professor
CONTACT
Ataturk University
Other
Assessment of Left Ventricular Function Before Decannulation in Cardiopulmonary Bypass Surgeries: Comparison of the Cardiac Surgeon's Visual Estimation and Transesophageal Echocardiography
Acronym: LVFuncTee
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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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