Binah.ai Visual Vitals Application - Validation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Respiratory Rate accuracy validation
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Respiratory Rate accuracy validation
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported