Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

NCT06508047 | Completed Results FDA Device

• 1 other identifier: PR 2024-593
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Vital Sign Evaluation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Informed Vital Core App DEVICE

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.

Informed Vital Core App

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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):

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mindset Medical: lead

Study Sites (1)

Element Materials Techonology

Louisville, Colorado, 80027, United States

Location

Results Point of Contact

• Title: Jeremy Markovich
• Organization: Mindset Medical

jeremy@mindsetmedical.com

8583055323

Study Officials

• Monica Rabanal

  Element Materials Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 16, 2024
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: March 18, 2026
• Results First Posted: March 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)