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

A

Ataturk University

Status

Not yet enrolling

Conditions

Cardiopulmonary Bypass Surgery
Left Ventricular Dysfunction

Treatments

Diagnostic Test: Intraoperative Left Ventricular Function Assessment

Study type

Observational

Funder types

Other

Identifiers

NCT07286227
B.30.2.ata.0.01.00/767

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Cardiopulmonary Bypass Cohort
Description:
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.
Treatment:
Diagnostic Test: Intraoperative Left Ventricular Function Assessment

Trial contacts and locations

1

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Central trial contact

Muhammed Enes Aydin, Associate Professor; Filiz Albayrak, assistant doctor

Data sourced from clinicaltrials.gov

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