Binah.ai Visual Vitals Application - Validation Study

Binah.ai

Status: Completed

Conditions: Respiratory and Pulse Rate Accuracy Validation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05539612

2021-455

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design