Smartwatch-based Automated Cardiac Arrest Detection and Activation of the Emergency Medical Chain: Validation in a Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity for cardiac arrest detection
研究概览
简要总结
Surviving a cardiac arrest that happens outside the hospital depends on quickly recognizing the event and immediately starting CPR. Survival rates have improved when cardiac arrest is witnessed, but when it isn't, help often arrives too late. Wearable biosensors, like special wristbands, could detect cardiac arrest automatically and alert emergency responders, providing faster help.
In the already finished DETECT-1 study, the investigators developed a system that uses wrist-worn sensors to identify cardiac arrest. The goal of the current study is to test how well this system works in people who have an implantable cardioverter defibrillator (ICD). An ICD is a device that monitors and treats dangerous heart rhythms. Study participants will wear a medical wristband with sensors that monitor the heartrate and movement during their daily activities to see if the system accurately detects cardiac arrest.
详细描述
Survival from out-of-hospital cardiac arrest (OHCA) depends on fast recognition of cardiac arrest and immediate initiation of cardiopulmonary resuscitation (CPR). While survival chances for witnessed OHCA have increased, unwitnessed cases still often receive help too late. Wearable biosensor technology with the functionality of automated cardiac arrest detection and activation of the emergency medical chain would offer a potential solution to provide early help. In the recently published DETECT-1 study, an algorithm for automated cardiac arrest detection using wrist-derived photoplethysmography (PPG) was recently developed.
The current study is a prospective multicenter observational cohort study to validate the sensitivity of the developed cardiac arrest detection algorithm in patients with an implantable cardioverter defibrillator (ICD) during daily life. The study population includes patients with an ICD. Study participants will wear a medical wristband with PPG and accelerometer sensors during daily life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an implantable cardioverter defibrillator (ICD)
- •Age 18 years or older
- •Fitting the wristband
- •In possession of a smartphone that is compatible with the wristband
排除标准
- •Known hemodynamically relevant bilateral subclavian artery stenosis
- •Medical issues that interfere with wearing of the wristband (e.g. skin disorders)
- •Insufficient skills to operate with the device/app
结局指标
主要结局
Sensitivity for cardiac arrest detection
时间窗: From the time of enrollment to the end of the wearing period of the wristband (maximal two years)
The number of correctly identified cardiac arrest events by the algorithm devided by the total number of cardiac arrest events.
次要结局
- Positive predictive value for cardiac arrest detection(From the time of enrollment to the end of the wearing period of the wristband (maximal two years))
- False positive alarm rate(From the time of enrollment to the end of the wearing period of the wristband (maximal two years))