Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application

• Conditions: Vital Sign Evaluation
• Interventions: Device: Informed Vital Core App

• Registration Number: NCT06508047
• Lead Sponsor: Mindset Medical

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Study Start: 2024-07-16
• Study First Posted: 2024-07-18
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-08-30
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Informed Vital Core App	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.

Primary Outcome Measures

Name	Time	Method
Respiratory Rate Accuracy	60 seconds	The primary outcome measure is a Respiratory Rate accuracy validation comparing the Mindset Medical Application to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) by manually scoring the collected waveform for data analysis.

Trial Locations

Locations (1)

Element Materials Techonology; 🇺🇸 Louisville, Colorado, United States