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This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.
In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to two commercially available Masimo pulse oximeter devices in a single visit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There is no intervention | Other | There is no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse Rate Verification | To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices | 2 months |
| Respiration Rate Verification | To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Tone Pulse Rate Verification | To demonstrate that mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones. | 2 months |
| Skin Tone Respiration Rate Verification |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy Volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InteloMed, Inc. | Cranberry Township | Pennsylvania | 16066 | United States |
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To demonstrate that mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones.
| 2 months |