Analysis of the Efficacy and Stability of a Single-Channel Patch-Type Wearable Electrocardiogram Monitor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- The number of total QRS complex
研究概览
简要总结
This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring
详细描述
This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring. After the data collection is completed, a satisfaction survey will be conducted with the medical staff. The data obtained simultaneously from HiCardi+ and MX40 will be analyzed, and the satisfaction survey responses from the medical staff will be reviewed to confirm the clinical convenience of the patch-type ECG monitoring device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients admitted to Chonnam National University Hospital who require ECG monitoring
- •Individuals who have expressed their intention to participate in this study or have obtained written consent from a proxy
排除标准
- •Individuals who are unable to provide consent themselves or through a legally designated representative
- •Individuals deemed unsuitable for participation in the clinical trial based on the researcher's judgment
结局指标
主要结局
The number of total QRS complex
时间窗: Within 3 months after electrocardiogram monitoring procedure
Number of total QRS complex is compared based on the data obtained simultaneously from two devices.
The rate of signal loss
时间窗: Within 3 months after electrocardiogram monitoring procedure
Rate of signal loss is compared based on the data obtained simultaneously from two devices.
次要结局
- Average heart rate(Within 3 months after electrocardiogram monitoring procedure)
- The number of arrhythmia and technical alarm(Within 3 months after electrocardiogram monitoring procedure)
- Results of satisfaction survey(Within 3 months after electrocardiogram monitoring procedure)