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

2026년 9월 20일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

관찰

등록 (실제)

93

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Difference Between AI and Anesthesiologist M-Mode Assessment of LVEF
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 3월 28일

기본 완료 (실제)

2026년 8월 22일

연구 완료 (실제)

2026년 8월 22일

연구 등록 날짜

최초 제출

2026년 9월 14일

QC 기준을 충족하는 최초 제출

2026년 9월 20일

처음 게시됨 (실제)

2026년 9월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 20일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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