NCT05539612已完成不适用
Binah.ai Visual Vitals Application - Validation Study
Binah.ai LTD.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年7月18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
- 30
- 试验地点
- 1
- 主要终点
- Respiratory Rate accuracy validation
研究概览
简要总结
The purpose of this study is to conduct a Respiratory and Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda), and a standard ECG reference (respectively).
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
- •Subject must have the ability to understand and provide written informed consent
- •Subject must be ≥18 years of age
- •Subject must be willing and able to comply with study procedures and duration
排除标准
- •Subjects who refuse or are unable to provide to sign an informed written consent for study
- •Participants evaluated by the Investigator and Clinical Staff and found to be medically unsuitable or have self-reported health conditions that are currently unstable as identified in the Health Assessment Form and Health Screening
- •Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor Region Of Interest (ROI) which would limit the ability to test ROI needed for the study.
- •Tattoo in the optical path which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular areas utilized.)
- •Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
- •Other known health condition, should be considered upon disclosure in health assessment form
结局指标
主要结局
Respiratory Rate accuracy validation
时间窗: From admission to discharge, up to 2 hours
Respiratory Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).
Pulse Rate accuracy validation
时间窗: From admission to discharge, up to 2 hours
Pulse Rate accuracy validation comparing the Binah.ai Visual Vitals Application to the Reference, a standard ECG.
次要结局
未报告次要终点
研究者
研究点 (1)
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