Use of Caption AI to Perform a Clinically Indicated Transthoracic Echocardiogram in Patients Being Evaluated for or Positive for COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Percent of patient echos that are not interpretable
研究概览
简要总结
Participants scheduled for for an echocardiogram (echo) and being evaluated for, or is positive for COVID-19 will be asked if they would be willing to have their echo done using a new software program on one of the hand-held ultrasound scanners.
The new software program guides the investigator, or any other non-sonographer, to take the best possible pictures of the participants heart. The prior version of this software is already being used clinically and is FDA approved. The main reason for using the updated version is that it's faster and better in terms of guiding the user.
详细描述
To enable healthcare professionals that are not proficient in transthoracic echo (TTE) to acquire images in patients being evaluated for or positive for COVID-19. By leveraging the capabilities of the Caption AI which is designed to train novice users on how to acquire TTE, this would minimize the risk of sonographers to be exposed to COVID-19. Additionally, minimizing sonographer interaction with patients being evaluated for or positive for COVID 19 minimizes the risk of sonographers as vectors for transmission to other patients. Lastly, since the Caption AI device will be dedicated to the COVID wards and COVID ICU and not transported to other locations, use of the CAPTION AI device will help to limit viral transmission via the surfaces of the ultrasound machine. These images will be assessed by qualified medical professionals for diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duke patients within the MICU and COVID overflow areas
- •transthoracic echocardiogram ordered by their provider
- •suspected or positive for COVID-
- •Patients who consent to participating in the study or Physician discretion that information to be gained is important to the patient
- •Patients ≥18 years old
排除标准
- •Unable to lie flat for study
- •Patients unwilling to give consent
结局指标
主要结局
Percent of patient echos that are not interpretable
时间窗: Up to 1 hour
Images obtained through the point of care AI machine will be uploaded to the cardiology PACS system and read. If the images are felt to be not interpretable, the echo lab will send a sonographer with a regular echo machine to the patient's room to perform the study.
Time to acquire images as measured by time stamps
时间窗: up to 1 hour
Percent of patient echos that provide an automated (AI) LVEF (left ventricular ejection fraction)
时间窗: Up to 1 hour
There need to be enough images taken of sufficient quality to allow for calculation of an automated LVEF by the AI algorithm
次要结局
- Percent of agreement between AI calculate LVEF and LVEF read by physician(Up to 24 hours)