Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

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).

Study Overview

• Status: Completed
• Conditions: Vital Sign Evaluation
• Intervention / Treatment: Device: Informed Vital Core App

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Element Materials Techonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

At least 30% of the participants will be male At least 30% of the participants will be female

At least 33% of the participants will be with BMI between 25.0 to 29.9 kg/m2 (overweight) At least 33% of the participants will be with BMI > 30.0 kg/m2 (obese)

At least 15% of participants will have a light skin tone (Fitzpatrick Scale 1 or 2) At least 15% of participants will have a medium skin tone (Fitzpatrick Scale 3 or 4) At least 15% of participants will have a dark skin tone (Fitzpatrick Scale 5 or 6)

The study will attempt to enroll a race/ethnicity distribution similar to population demographics consistent with the 2020 US Census Data

At least 5 participants will have a history of smoking

At least 10 participants with chronic conditions (self-reported):

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Informed Vital Core App; 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.	Device: Informed Vital Core App; Informed Vital Core App will be initiated by the study staff to take a measurement, which takes 60 seconds to calculate and report a breathing rate value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Rate Accuracy	The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the Device Under Test (DUT) and the Reference (Ref) Respiratory Rate as counted using the End Tidal Carbon Dioxide scored waveform by counting the respiratory peaks per minute for all stable respiratory periods.	60 seconds

Collaborators and Investigators

• Sponsor: Mindset Medical
• Investigators: Principal Investigator: Monica Rabanal, Element Materials Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): August 22, 2024
• Study Completion (Actual): August 22, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PR 2024-593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No