Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Mean Average Error (MAE)
研究概览
简要总结
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
详细描述
The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •Male or female subjects aged 18 or over
- •Ability to provide signed informed consent
排除标准
- •Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator
结局指标
主要结局
Mean Average Error (MAE)
时间窗: Up to 1 hour
MAE will be evaluated by Mean absolute error (MAE) of the pulse rate of the device compared to the heart rate measured from the RCECG.
次要结局
未报告次要终点