RAPID: a Comparison Study of a Novel Ultrasound Device of Automated Congenital Heart Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- RAPID imaging quality
研究概览
简要总结
The RAPID ultrasound is a portable imaging device that captures a one point image from the subcostal region of the heart. The device is set on the patient's chest and captures the image in <1 minute. It uses ultrasound imaging energy that is similar to commercialized devices and safe for patients of all ages and sizes. The device is a non-significant risk and therefore will not require an IDE. Images from RAPID will be taken directly before or after the standard clinical PCU. Images taken from both the RAPID device and the standard PCU will be de-identified and stored securely in BOX for review by two independent cardiologists. Image reviews will be conducted within Box.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<1 years old
- •Be a patient at Masonic Children's Hospital or Masonic Children's Heart Center clinic undergoing PCU
排除标准
- •Open Chest
- •Deemed medically unstable by care team
- •Cardiology, ICU, hospitalist or bedside nurse concerns
研究组 & 干预措施
study group
Caregivers who have a child with a scheduled Pediatric congenital ultrasound (PCU) the day of recruitment
干预措施: RAPID (Device)
结局指标
主要结局
RAPID imaging quality
时间窗: 30minutes
comparing the result of the data and imaging collected from the gold standard (PCU) vs the prototype device (RAPID) Two independent cardiologists will review each de-identified image in a large batch of standardized images consisting of random images from both RAPID and PCU. Each image will be reviewed by the cardiologists based on a specific checklist
次要结局
未报告次要终点