Vital Sign Evaluation
Conditions
Brief summary
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).
Interventions
DEVICEInformed Vital Core App
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.
Sponsors
Mindset Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse Rate Accuracy | 120 seconds | The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate. |
Countries
United States
Participant flow
Recruitment details
The study recruited subjects from clinics, hospitals, and the general public. The study was conducted in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Open Label, Single Group Assignment | 82 |
| Total | 82 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 48.7 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| IVC App Pulse Rate | 69.0 Beats per Minute |
| IVC App Report Rate | 69 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 82 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 82 |
| other Total, other adverse events | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 |
Outcome results
Primary
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
Population: Intent to Capture
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Pulse Rate Accuracy | 67 Participants |
Comparison: Subjects with simultaneously collected HR and PR comparator data were assigned to the comparison group.95% CI: [0.67, 0.87]