Clinical trial NCT05539612: Binah.ai Visual Vitals Application - Validation Study
Official title: Binah.ai Visual Vitals Application - Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory and Pulse Rate Accuracy Validation
Lead sponsor: Binah.ai LTD.
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2022-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is carefully designed to represent the intended population for the intended use of the Binah.ai Visual Vitals Application. The study population will be comprised of diversity in race, age, gender, BMI, skin tone, and health conditions. The health conditions will constitute certain proportions of healthy controls (to allow testing over the full range of breaths per minute) and disease comorbidities (to represent comorbidities such as COPD, CHF, Asthma, Diabetes, Hypertension, Diabetes and Obesity).

The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Rate accuracy validation
timeFrame: From admission to discharge, up to 2 hours
measure: Pulse Rate accuracy validation
timeFrame: From admission to discharge, up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark, LLC
state: Colorado
Study officials:
References: