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The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal subjects | No Intervention | ||
| respiratory suppressing drugs | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respilife monitor | Diagnostic Test | Respilife monitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| oxygen saturation percentage using photoplethysmography | The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer. | 6 hours |
| Respiratory rate, breaths per minute using photoplethysmography | The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography. | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peninsula Sleep Center | Burlingame | California | 94010-3224 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 26, 2019 | |
| Reset | Aug 13, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 26, 2019 | Aug 13, 2019 |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Evaluation of the device on people with normal and suppressed respiration
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