Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Artificial Intelligence Versus Anesthesiologist Visual Assessment of Ejection Fraction by Transesophageal Echocardiography During Cardiac Surgery

20 september 2026 bijgewerkt door: Ain Shams University

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

93

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypte
        • Cardiothoracic Surgery Academy, Ain Shams University Hospitals

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
Tijdsspanne: 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.

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF
Tijdsspanne: During cardiac surgery, at the time of the intraoperative TEE assessment

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.

During cardiac surgery, at the time of the intraoperative TEE assessment
Time Required for AI and Anesthesiologist LVEF Assessment
Tijdsspanne: 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.

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.

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

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.

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 maart 2026

Primaire voltooiing (Werkelijk)

22 augustus 2026

Studie voltooiing (Werkelijk)

22 augustus 2026

Studieregistratiedata

Eerst ingediend

14 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2026

Eerst geplaatst (Werkelijk)

25 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

20 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren