Evaluation of interval, duration, and amplitude of ECG in smartphone based ECG device as compared to GOLD Standard.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- determine the equivalency of the smartphone ECG device in comparison to the Goldstandard ECG machine for measuring the morphological parameters like PR intervals and QRS duration under the Clinical level of Agreement and less margin of error
研究概览
简要总结
This study is designed as a prospective, single-blinded, cross-sectional comparison to evaluate parameters and amplitude against a gold-standard ECG device in 1,000 patients. It includes all patients referred by a cardiologist for an ECG test in the ECG room, excluding those with underlying electrical disturbances and motion artifacts. Pregnant women and individuals with loose skin or a high density of chest hair are also excluded. The primary outcome measure focuses on evaluating the intervals, durations, and amplitude of the ECG in comparison to the gold standard. The secondary outcome measure aims to validate the accuracy of Spandan 12 Lead ECG in trace detection
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •All IPD and OPD patients referred by the cardiologist for ECG tests in the ECG laboratory will be included.
排除标准
- •Subjects aged below 20 years were excluded from the study.
- •ECG reports with underlying electrical disturbances and motion artifacts were also excluded.
- •Pregnant females.
- •Individuals with loosened skin and high density of chest hairs.
- •The device is not to be used with a defibrillator.
结局指标
主要结局
determine the equivalency of the smartphone ECG device in comparison to the Goldstandard ECG machine for measuring the morphological parameters like PR intervals and QRS duration under the Clinical level of Agreement and less margin of error
时间窗: 2 weeks
次要结局
- To access the feasibility(and usability of the smartphone based ECG device in accessing the ECG from the patients & also to evaluate its accuracy when used in ECG room.)
研究者
Chandra Mohan Belwal
Himalayan institute of Medical Sciences