A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients

Mindset Medical86 enrolled

Overview

Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vital Sign Evaluation

Interventions

Informed Vital Core AppDEVICE

All subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects 22 -85 years of age * Subjects willing to sign the Informed Consent Form and comply with the protocol Exclusion Criteria * Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin * Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement * Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject * Condition that does not allow the subject to remain still for 60 seconds at a time * Subjects with cardiac arrhythmia * Any known medical condition which may result in an inaccurate measurement using the reference device * Subjects with the inability to complete an ECG.

Locations (6)

Velocity Clinical Research

Mobile, Alabama, United States

Velocity Clinical Research

La Mesa, California, United States

Velocity Clinical Research

Meridian, Idaho, United States

Velocity Clinical Research

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Pulse Rate Accuracy

The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.

Time frame: 120 seconds

Data from ClinicalTrials.gov

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