Left Ventricular FunctionNCT07841327
Artificial Intelligence Versus Anesthesiologist Visual Assessment of Ejection Fraction by Transesophageal Echocardiography During Cardiac Surgery
An observational study of Left Ventricular Function and Cardiac Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective observational study evaluated the reliability of a general-purpose artificial intelligence application in estimating left ventricular ejection fraction from intraoperative transesophageal echocardiography images during cardiac surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Left Ventricular Function, Cardiac Surgery
- What is being tested?
- Artificial Intelligence Assessment of TEE Images
- How many people
- 93 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2026to 22 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 21 years or older who were scheduled for elective coronary artery bypass grafting, valve repair, or valve replacement surgery at the Cardiothoracic Surgery Academy, Ain Shams University and had an available preoperative transthoracic echocardiographic assessment.
Who may be able to join
- Age 21 years or older.
- Scheduled for elective cardiac surgery involving coronary artery bypass grafting, valve repair, or valve replacement.
- Availability of a preoperative transthoracic echocardiographic assessment.
- Either sex.
- American Society of Anesthesiologists physical status III or IV.
Who cannot join
- Coagulopathy, defined as an international normalized ratio greater than 2 or a platelet count below 50,000/mm3.
- Previous cardiac surgery (redo procedure).
- Esophageal or upper gastrointestinal pathology preventing safe transesophageal echocardiography probe placement, including esophageal stricture, tumor, or large varices.
- Poor-quality transesophageal echocardiography images despite standard optimization, preventing reliable interpretation.
- Severe arrhythmia or hemodynamic instability before surgery, during induction, or during surgery that could compromise the accuracy of the transesophageal echocardiography assessment.
- Refusal to participate or a condition limiting valid consent or participation, including cognitive impairment or a language barrier.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cardiothoracic Surgery Academy, Ain Shams University Hospitals
Cairo, Cairo Governorate
About this study
Official title: Reliability of Artificial Intelligent General Application in Assessing Ejection Fraction in Comparison to Anesthesiologist Eye Ball by Trans Oesophageal Echo During Cardiac Surgery
This prospective observational study evaluated the reliability of a general-purpose artificial intelligence application in estimating left ventricular ejection fraction from intraoperative transesophageal echocardiography images during cardiac surgery. The artificial intelligence estimates were compared with visual assessment by two independent blinded professor anesthesiologists and with preoperative transthoracic echocardiography findings. Ejection fraction measured using M-mode and the time required for each assessment were also evaluated. The study included 93 adults undergoing elective coronary artery bypass grafting or valve surgery. The artificial intelligence assessments were performed using pseudonymized images and were not used to guide clinical decisions or patient management.
Read the detailed description
This was a prospective, single-cohort observational study conducted at the Cardiothoracic Surgery Academy, Ain Shams University. Adults aged 21 years or older undergoing elective coronary artery bypass grafting or valve repair or replacement surgery were enrolled consecutively after providing written informed consent.
After induction of anesthesia and hemodynamic stabilization, transesophageal echocardiography images were obtained using a transgastric short-axis view at the mid-papillary level and an angle of 0 degrees. End-diastolic and end-systolic frames and an M-mode recording were collected for assessment of left ventricular ejection fraction.
Pseudonymized echocardiographic images were assessed using a general-purpose artificial intelligence application. The same images were independently assessed by two blinded professor anesthesiologists who had no access to the artificial intelligence output or the other assessments. Visual estimation of ejection fraction, M-mode-derived ejection fraction, and interpretation time were recorded. These findings were also compared with the preoperative transthoracic echocardiography assessment.
The artificial intelligence output was used exclusively for research and was not used to make or modify any clinical decision. A total of 93 eligible participants were included in the final analysis.
- Conditions
- Left Ventricular Function, Cardiac Surgery
- Being tested
- Artificial Intelligence Assessment of TEE Images
- Keywords
- Artificial Intelligence, Transesophageal Echocardiography, Left Ventricular Ejection Fraction, Visual Estimation, M-Mode Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence Assessment of TEE ImagesDiagnostic test
Pseudonymized end-diastolic and end-systolic frames and an M-mode recording obtained from the transgastric short-axis mid-papillary view at 0 degrees were analyzed by a general-purpose artificial intelligence application to estimate left ventricular ejection fraction. The artificial intelligence results were compared with assessments by two independent blinded professor anesthesiologists and with preoperative transthoracic echocardiography. The artificial intelligence output was used only for research and did not guide clinical management.
| Study group | Role | What they receive |
|---|---|---|
| Elective Cardiac Surgery Patients | A single cohort of 93 adult patients undergoing elective coronary artery bypass grafting or valve repair or replacement surgery. Intraoperative transesophageal echocardiography images were evaluated for left ventricular ejection fraction using artificial intelligence, anesthesiologist visual assessment, and M-mode echocardiography. Receives: Diagnostic Test: Artificial Intelligence Assessment of TEE Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
Left ventricular ejection fraction was assessed from the same intraoperative transesophageal echocardiography transgastric short-axis mid-papillary view at 0 degrees by a general-purpose artificial intelligence application and by two independent blinded professor anesthesiologists using visual (eyeball) assessment. The paired assessments were compared to evaluate the difference and agreement between the artificial intelligence and anesthesiologist assessments.
Measured: During cardiac surgery, at the time of the intraoperative TEE assessment
Secondary outcomes (3)
Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF
Left ventricular ejection fraction was assessed using M-mode in the intraoperative transesophageal echocardiography transgastric short-axis mid-papillary view at 0 degrees by a general-purpose artificial intelligence application and by two independent blinded professor anesthesiologists. The paired M-mode ejection fraction assessments were compared to evaluate the difference and agreement between methods.
Measured: During cardiac surgery, at the time of the intraoperative TEE assessment
Time Required for AI and Anesthesiologist LVEF Assessment
The time required for the general-purpose artificial intelligence application and the anesthesiologist assessors to complete the visual (eyeball) and M-mode left ventricular ejection fraction assessments was recorded separately using a timer and reported in seconds. Assessment times were compared between the artificial intelligence and anesthesiologist methods.
Measured: During intraoperative TEE image review, from the start of each visual (eyeball) or M-mode LVEF assessment until the corresponding estimate is completed, assessed up to 3 minutes per assessment per participant.
Difference Between Intraoperative TEE and Preoperative TTE LVEF Assessments
Left ventricular ejection fraction estimates obtained from intraoperative transesophageal echocardiography by the general-purpose artificial intelligence application and the blinded anesthesiologist assessors were compared with the available preoperative transthoracic echocardiography ejection fraction for the same participant. The difference between each intraoperative assessment and the preoperative transthoracic echocardiography value was evaluated.
Measured: From the available preoperative TTE assessment to the intraoperative TEE assessment during cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start28 Mar 2026
- Primary completion22 Aug 2026
- Study completion22 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular FunctionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841327
- Sponsor's protocol ID
- FMASU MS 82/2026
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because external sharing of participant-level data was not included in the approved study protocol, ethics approval, or informed consent. Only aggregate study results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Artificial Intelligent General Application in Assessing Ejection Fraction in Comparison to Anesthesiologist Eye Ball by Trans Oesophageal Echo During Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07841327
- Acronym / sponsor ID
- FMASU MS 82/2026
- Conditions
- Left Ventricular Function, Cardiac Surgery
- Keywords
- Artificial Intelligence, Transesophageal Echocardiography, Left Ventricular Ejection Fraction, Visual Estimation, M-Mode Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Mar 2026 (actual)
- Primary completion
- 22 Aug 2026 (actual)
- Study completion
- 22 Aug 2026 (actual)
- First posted
- 25 Sep 2026 (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 prospective observational study evaluated the reliability of a general-purpose artificial intelligence application in estimating left ventricular ejection fraction from intraoperative transesophageal echocardiography images during cardiac surgery. The artificial intelligence estimates were compared with visual assessment by two independent blinded professor anesthesiologists and with preoperative transthoracic echocardiography findings. Ejection fraction measured using M-mode and the time required for each assessment were also evaluated. The study included 93 adults undergoing elective coronary artery bypass grafting or valve surgery. The artificial intelligence assessments were performed using pseudonymized images and were not used to guide clinical decisions or patient management.
Detailed description
This was a prospective, single-cohort observational study conducted at the Cardiothoracic Surgery Academy, Ain Shams University. Adults aged 21 years or older undergoing elective coronary artery bypass grafting or valve repair or replacement surgery were enrolled consecutively after providing written informed consent.
After induction of anesthesia and hemodynamic stabilization, transesophageal echocardiography images were obtained using a transgastric short-axis view at the mid-papillary level and an angle of 0 degrees. End-diastolic and end-systolic frames and an M-mode recording were collected for assessment of left ventricular ejection fraction.
Pseudonymized echocardiographic images were assessed using a general-purpose artificial intelligence application. The same images were independently assessed by two blinded professor anesthesiologists who had no access to the artificial intelligence output or the other assessments. Visual estimation of ejection fraction, M-mode-derived ejection fraction, and interpretation time were recorded. These findings were also compared with the preoperative transthoracic echocardiography assessment.
The artificial intelligence output was used exclusively for research and was not used to make or modify any clinical decision. A total of 93 eligible participants were included in the final analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cardiac Surgery Patients | – | Diagnostic Test: Artificial Intelligence Assessment of TEE ImagesA single cohort of 93 adult patients undergoing elective coronary artery bypass grafting or valve repair or replacement surgery. Intraoperative transesophageal echocardiography images were evaluated for left ventricular ejection fraction using artificial intelligence, anesthesiologist visual assessment, and M-mode echocardiography. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 21 years or older who were scheduled for elective coronary artery bypass grafting, valve repair, or valve replacement surgery at the Cardiothoracic Surgery Academy, Ain Shams University and had an available preoperative transthoracic echocardiographic assessment.
Key inclusion criteria (5 listed)
- Age 21 years or older.
- Scheduled for elective cardiac surgery involving coronary artery bypass grafting, valve repair, or valve replacement.
- Availability of a preoperative transthoracic echocardiographic assessment.
- Either sex.
- American Society of Anesthesiologists physical status III or IV.
Key exclusion criteria (6 listed)
- Coagulopathy, defined as an international normalized ratio greater than 2 or a platelet count below 50,000/mm3.
- Previous cardiac surgery (redo procedure).
- Esophageal or upper gastrointestinal pathology preventing safe transesophageal echocardiography probe placement, including esophageal stricture, tumor, or large varices.
- Poor-quality transesophageal echocardiography images despite standard optimization, preventing reliable interpretation.
- Severe arrhythmia or hemodynamic instability before surgery, during induction, or during surgery that could compromise the accuracy of the transesophageal echocardiography assessment.
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 |
|---|---|---|
| Artificial Intelligence Assessment of TEE ImagesPseudonymized end-diastolic and end-systolic frames and an M-mode recording obtained from the transgastric short-axis mid-papillary view at 0 degrees were analyzed by a general-purpose artificial intelligence application to estimate left ventricular ejection fraction. The artificial intelligence results were compared with assessments by two independent blinded professor anesthesiologists and with preoperative transthoracic echocardiography. The artificial intelligence output was used only for research and did not guide clinical management. | Diagnostic test | Elective Cardiac Surgery Patients |
Primary outcome
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
Time frame: During cardiac surgery, at the time of the intraoperative TEE assessment
Left ventricular ejection fraction was assessed from the same intraoperative transesophageal echocardiography transgastric short-axis mid-papillary view at 0 degrees by a general-purpose artificial intelligence application and by two independent blinded professor anesthesiologists using visual (eyeball) assessment. The paired assessments were compared to evaluate the difference and agreement between the artificial intelligence and anesthesiologist assessments.
3 secondary outcomes
Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF
Time frame: During cardiac surgery, at the time of the intraoperative TEE assessment
Time Required for AI and Anesthesiologist LVEF Assessment
Time frame: During intraoperative TEE image review, from the start of each visual (eyeball) or M-mode LVEF assessment until the corresponding estimate is completed, assessed up to 3 minutes per assessment per participant.
Difference Between Intraoperative TEE and Preoperative TTE LVEF Assessments
Time frame: From the available preoperative TTE assessment to the intraoperative TEE assessment during cardiac surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because external sharing of participant-level data was not included in the approved study protocol, ethics approval, or informed consent. Only aggregate study results will be reported.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Left Ventricular Function and Cardiac Surgery, run by Ain Shams University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 25 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Between AI and Anesthesiologist Visual Assessment of LVEF (time frame: During cardiac surgery, at the time of the intraoperative TEE assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2026.