Ireland
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Recruiting Observational

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

NCT07286227 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-01-01
Last updated
2026-09-04

Condition(s) studied

Cardiopulmonary Bypass SurgeryLeft Ventricular Dysfunction

Investigational drug(s) / intervention(s)

Intraoperative Left Ventricular Function Assessment

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07286227 on ClinicalTrials.gov ↗ ← All trials in Turkey