Reliability of Artificial Intelligent General Application in Assessing Ejection Fraction in Comparison to Anesthesiologist Eye Ball by Trans Oesophageal Echo During Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Difference Between AI and Anesthesiologist Visual Assessment of LVEF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Coagulopathy, defined as an international normalized ratio greater than 2 or a platelet count below 50,000/mm
- •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.
研究组 & 干预措施
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.
干预措施: Artificial Intelligence Assessment of TEE Images (Diagnostic Test)
结局指标
主要结局
Difference Between AI and Anesthesiologist Visual Assessment of LVEF
时间窗: 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.
次要结局
- 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)