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2022年7月18日

适应症Respiratory and Pulse Rate Accuracy Validation

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Respiratory and Pulse Rate Accuracy Validation
发起方: Binah.ai LTD.
入组人数: 30
试验地点: 1
主要终点: Respiratory Rate accuracy validation
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2022年7月18日

结束日期

2022年8月12日

最后更新

3年前

研究类型

Observational

性别

All

研究者

发起方

Binah.ai LTD.

责任方

Sponsor

入排标准

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.