跳至主要内容
临床试验/NCT07286227
NCT07286227招募中不适用

Assessment of Left Ventricular Function Before Decannulation in Cardiopulmonary Bypass Surgeries: Comparison of the Cardiac Surgeon's Visual Estimation and Transesophageal Echocardiography

Ataturk University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Cardiopulmonary Bypass Cohort

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.

干预措施: Intraoperative Left Ventricular Function Assessment (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Diagnostic Accuracy of Surgeon Visual Estimation for Detecting Reduced Left Ventricular Function(During the decannulation phase of cardiopulmonary bypass (intraoperative period))
  • Prediction of Postoperative Hemodynamic Support Requirement(From intraoperative decannulation through 24 hours postoperatively)
  • Correlation Between Quantitative TEE Measurements and Surgeon Visual Estimation(During the decannulation phase of cardiopulmonary bypass)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed E Aydin

DOÇENT.DR

Ataturk University

研究点 (2)

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