Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

Mindset Medical

Status: Completed

Conditions: Vital Sign Evaluation

Treatments: Device: Informed Vital Core App

Study type: Observational

Funder types: Industry

Identifiers

NCT06508047

PR 2024-593

Details and patient eligibility

About

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including respiratory rate (RR). The purpose of the study is to conduct accuracy validation when compared to a FDA-cleared/approved vital sign monitoring device (reference device).

Enrollment: 65 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must have the ability to understand and provide written informed consent or have legally authorized representative consent to participate.
• Participant must be ≥22 years of age
• Participant must be willing and able to comply with study procedures and duration
• Participants or legally authorized representative must be able to read or write in English

Exclusion criteria

• Participants who refuse or are unable 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 the Region of Interest (ROI) which would limit the ability to test ROI needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular areas utilized.)
• Participants 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

65 participants in 1 patient group

Informed Vital Core App

Description:

All subjects assigned to a single arm, respiration rate measurement will be collected, calculated, and displayed on the web based application. Conventional Capnography will also be used to collect and display the respiratory rate at the same time as the Informed Vital Core App.

Treatment:

Device: Informed Vital Core App