Validation of a High-Quality Low-Cost Open-Source Electrocardiograph (ECG)
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG
研究概览
简要总结
The high price of electrocardiograph (ECG) devices - with most hospital-grade devices costing thousands of dollars - is one of the barriers to access of this vital technology. There is a shortage of ECG devices in underserved areas and the devices available on the market currently are not adequate to solve this problem. Our solution is a low-cost high-quality open-access ECG device. This study intends to validate the study ECG device in human patients by demonstrating equivalence between the study ECG device and a gold standard device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- All study participants must be able to provide written informed consent prior to study procedure. This study has 2 Phases.
- •> 18 years of age
- •> 18 years of age
- •non critical patients presenting to the emergency department (Victoria Hospital and University Hospital) with cardiac complaint
排除标准
- •< 18 years old
- •Unable to consent
- •> 70 years of age
- •Previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction, congestive heart failure)
- •current status of non-sinus heart rhythm
- •- Critical patients in the ED where consent would inappropriately delay investigations or treatment
结局指标
主要结局
Equivalence of Electrical Signals between 3D printed ECG device and Gold Standard ECG
时间窗: 60 seconds
Comparing electrical signals from ECG electrodes with tested device and gold standard device by collecting the following data from both devices: rate, QR interval, PR interval, QT interval, and rhythm.
次要结局
未报告次要终点
研究者
Tarek Loubani, MD
Principal Investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's