Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
研究概览
简要总结
This study will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance in pediatric patients by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis.
详细描述
[How to conduct research] This study targeted more than 29 days old and less than 19 years old. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics of Samsung Medical Center. The medical staff attaches the Holter device to the subject and the patch-type electrocardiograph in the Holter examination room. Holter device and patch-type electrocardiograph are returned to the Holter examination room after measuring the electrocardiogram for 24 hours. ECG signals from patch-type electrocardiographs and commercial Holter device and arrhythmia detection information are compared and analyzed.
[Number of Subjects] The number of this study is 105. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics.
[Data analysis plan] In this study, the personal identification information of the subjects will be coded non-identifying and the collected electrocardiogram data will be stored in the cloud with restricted access from outsiders. Coded, non-identified research data is stored and managed in the cloud in compliance with privacy standards and information security standards. ECG data transmitted through the mobile application is stored in the cloud. Confidentiality and security of data are guaranteed, and data collected from patch-type electrocardiograph is used only for research. The electrocardiogram data acquired in this study are obtained in TXT or MAT format and used for data analysis.
The efficacy evaluation items are as follows.
- Comparison of ECG signal concordance
- Comparison of the parameters below for a noise-free section of about 1 minute, not the entire section
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
- 29 Days 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 29 days old and less than 19 years old
- •Patients who are need regular Holter electrocardiography among outpatients or hospitalized patients at the Pediatrics, Samsung Medical Center
- •Those who gave written consent to this clinical study or obtained the written consent of the legal representative
排除标准
- •Patients who cannot give consent through the patient ownself or legal representative
- •If the researcher judges that participation in this study is inappropriate for other reasons
结局指标
主要结局
Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
时间窗: Within 3 months after electrocardiogram procedure
Rate of arrhythmia diagnosis between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories(total of 19 including ventricular ectopic beat)
Rate of ECG signal concordance between patch-type electrocardiograph and holter device
时间窗: Within 3 months after electrocardiogram procedure
Calculate the concordance (%) of the ECG signal by comparing and analyzing total QRS complex, total ventricular ectopic beats, total atrial ectopic beats, minimum heart rate(bpm), maximum heart rate(bpm), average heart rate(bpm) and maximum RR interval(ms)
次要结局
未报告次要终点