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

20 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

93

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

21 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de março de 2026

Conclusão Primária (Real)

22 de agosto de 2026

Conclusão do estudo (Real)

22 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de setembro de 2026

Primeira postagem (Real)

25 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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