NCT05853380已完成不适用
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Mindset Medical1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年6月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pulse Rate Accuracy
研究概览
简要总结
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).
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
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 22 -85 years of age
- •Subjects willing to sign the Informed Consent Form and comply with the protocol
- •Exclusion Criteria
- •Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
- •Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
- •Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
- •Condition that does not allow the subject to remain still for 60 seconds at a time
- •Subjects with cardiac arrhythmia
- •Any known medical condition which may result in an inaccurate measurement using the reference device
- •Subjects with the inability to complete an ECG.
排除标准
- 未提供
结局指标
主要结局
Pulse Rate Accuracy
时间窗: 120 seconds
The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.
次要结局
未报告次要终点
研究者
研究点 (1)
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