Cardiopulmonary Bypass SurgeryLVFuncTeeNCT07286227
Assement of Left Ventricular Function Before Decannulation in Cardiac Surgery :Visual Estimation vs TEE
An observational study of Cardiopulmonary Bypass Surgery and Left Ventricular Dysfunction, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiopulmonary Bypass Surgery, Left Ventricular Dysfunction
- What is being tested?
- Intraoperative Left Ventricular Function Assessment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 2 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at a single tertiary university hospital. The study population consists of individuals receiving CABG, valve surgery, or aortic surgery who meet eligibility criteria and undergo routine intraoperative TEE monitoring. Participants represent a typical clinical population of moderate-to-high surgical risk (ASA III-IV).
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum, 25000
Muhammed Enes Aydin, doctor, +90-554-331-82-89, enesmd@msn.com
Filiz Albayrak, assistant doctor, +90-545-226-98-49, zlfalbyrk@gmail.com
About this study
Official title: Assessment of Left Ventricular Function Before Decannulation in Cardiopulmonary Bypass Surgeries: Comparison of the Cardiac Surgeon's Visual Estimation and Transesophageal Echocardiography
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.
Read the 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.
- Being tested
- Intraoperative Left Ventricular Function Assessment
- Keywords
- Transesophageal Echocardiography, Left Ventricular Ejection Fraction, Visual Estimation, Eyeballing Method, Cardiac Surgery, Ejection Fraction Assessment, Intraoperative Monitoring, Decannulation, Cardiopulmonary Bypass
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Left Ventricular Function AssessmentDiagnostic test
Also called Visual Estimation (Eyeballing), Transesophageal Echocardiography (TEE)
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intraoperative Left Ventricular Function Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction
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.
Measured: During the decannulation phase of cardiopulmonary bypass (intraoperative period)
Secondary outcomes (3)
Diagnostic Accuracy of Surgeon Visual Estimation for Detecting Reduced Left Ventricular Function
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%).
Measured: During the decannulation phase of cardiopulmonary bypass (intraoperative period)
Prediction of Postoperative Hemodynamic Support Requirement
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.
Measured: From intraoperative decannulation through 24 hours postoperatively
Correlation Between Quantitative TEE Measurements and Surgeon Visual Estimation
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.
Measured: During the decannulation phase of cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed E Aydin, Ataturk University
- Investigators
- Muhammed Enes Aydın, Principal Investigator, Principal investigator, Ataturk University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286227
- Sponsor's protocol ID
- B.30.2.ata.0.01.00/767
- Acronym
- LVFuncTee
- Status last verified
- Sep 2026
- First submitted
- 3 Dec 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding IPD sharing has not yet been finalized. If data sharing is pursued in the future, it will involve de-identified datasets and will comply with institutional and ethical regulations.
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.
PubMed 23814646Abazid 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.
PubMed 29682476Metkus 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.
PubMed 33957241Bayram 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.
PubMed 30515038
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Left Ventricular Function Before Decannulation in Cardiopulmonary Bypass Surgeries: Comparison of the Cardiac Surgeon's Visual Estimation and Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT07286227
- Acronym / sponsor ID
- LVFuncTee / B.30.2.ata.0.01.00/767
- Keywords
- Transesophageal Echocardiography, Left Ventricular Ejection Fraction, Visual Estimation, Eyeballing Method, Cardiac Surgery, Ejection Fraction Assessment, Intraoperative Monitoring, Decannulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary Bypass Cohort | – | Diagnostic Test: Intraoperative Left Ventricular Function AssessmentPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery requiring cardiopulmonary bypass at a single tertiary university hospital. The study population consists of individuals receiving CABG, valve surgery, or aortic surgery who meet eligibility criteria and undergo routine intraoperative TEE monitoring. Participants represent a typical clinical population of moderate-to-high surgical risk (ASA III-IV).
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Left Ventricular Function AssessmentAlso: Visual Estimation (Eyeballing), Transesophageal Echocardiography (TEE)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. | Diagnostic test | Cardiopulmonary Bypass Cohort |
Primary outcome
Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 23814646Kim 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.
- Background: PubMed 29682476Abazid 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.
- Background: PubMed 33957241Metkus 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.
- Results publication: PubMed 30515038Bayram 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.
- Individual participant dataSharing planned: Undecided. The decision regarding IPD sharing has not yet been finalized. If data sharing is pursued in the future, it will involve de-identified datasets and will comply with institutional and ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammed Enes Aydın, Principal Investigator principal investigator
Ataturk University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass Surgery and Left Ventricular Dysfunction, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Enes Aydin, Associate Professor (+90-554-331-82-89, enesmd@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Surgeon Visual Estimation and TEE-Derived Left Ventricular Ejection Fraction (time frame: During the decannulation phase of cardiopulmonary bypass (intraoperative period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07286227, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.