NCT07841327

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2026

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

September 25, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 14, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

Artificial IntelligenceTransesophageal EchocardiographyLeft Ventricular Ejection FractionVisual EstimationM-Mode Echocardiography

Outcome Measures

Primary Outcomes (1)

  • 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.

    During cardiac surgery, at the time of the intraoperative TEE assessment

Secondary Outcomes (3)

  • Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF

    During cardiac surgery, at the time of the intraoperative TEE assessment

  • Time Required for AI and Anesthesiologist LVEF Assessment

    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

    From the available preoperative TTE assessment to the intraoperative TEE assessment during cardiac surgery

Study Arms (1)

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.

Diagnostic Test: Artificial Intelligence Assessment of TEE Images

Interventions

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.

Elective Cardiac Surgery Patients

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiothoracic Surgery Academy, Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 25, 2026

Study Start

March 28, 2026

Primary Completion

August 22, 2026

Study Completion

August 22, 2026

Last Updated

September 25, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations