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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Diagnostic test 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 wi

Primary outcome measures

• Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction [Time frame: During the decannulation phase of cardiopulmonary bypass (intraoperative period)]

Secondary outcome measures (3)

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Ataturk University — Erzurum

Publications

• Kim H. Weaning from cardiopulmonary bypass. Korean J Anesthesiol. 2013 Jun;64(6):487-8. doi: 10.4097/kjae.2013.64.6.487. No abstract available. PMID 23814646
• Abazid RM, Abohamr SI, Smettei OA, Qasem MS, Suresh AR, Al Harbi MF, Aljaber AN, Al Motairy AA, Albiela DE, Almutairi BM, Sakr H. Visual versus fully automated assessment of left ventricular ejection fraction. Avicenna J Med. 2018 Apr-Jun;8(2):41-45. doi: 10.4103/ajm.AJM_209_17. PMID 29682476
• Metkus TS, Thibault D, Grant MC, Badhwar V, Jacobs JP, Lawton J, O'Brien SM, Thourani V, Wegermann ZK, Zwischenberger B, Higgins R. Transesophageal Echocardiography in Patients Undergoing Coronary Artery Bypass Graft Surgery. J Am Coll Cardiol. 2021 Jul 13;78(2):112-122. doi: 10.1016/j.jacc.2021.04.064. Epub 2021 May 3. PMID 33957241
• Bayram E, Gulcu O, Aksu U, Aksakal E, Birdal O, Kalkan K. Evaluating the Association Between the Three Different Ejection Fraction Measurement Techniques and Left Ventricle Global Strain. Eurasian J Med. 2018 Oct;50(3):173-177. doi: 10.5152/eurasianjmed.2018.17409. PMID 30515038

Identifiers

NCT: NCT07286227 · B.30.2.ata.0.01.00/767

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗