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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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):
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| Name | Affiliation | Role |
|---|---|---|
| Monica Rabanal | Element Materials Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Element Materials Techonology | Louisville | Colorado | 80027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | breaths per minute | 60 seconds | breaths per minute | breaths per minute |
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One day, inclusive of the period of respiratory measurement.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Markovich | Mindset Medical | 8583055323 | jeremy@mindsetmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2024 | Jun 12, 2025 | Prot_SAP_000.pdf |
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| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
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