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| ID | Type | Description | Link |
|---|---|---|---|
| EMPA01 | Other Identifier | UCSF |
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| Name | Class |
|---|---|
| Empatica Srl | UNKNOWN |
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The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Comparison of EmbracePlus SpO2 readings with arterial blood saturation laboratory analysis in the same subject |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EmbracePlus | Device | A device intended for use by researchers and healthcare professionals for continuous collection of physiological parameters in home and healthcare settings. Parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter. |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy | SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter | Through study completion, 3 months average |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38111608 | Derived | Gerboni G, Comunale G, Chen W, Lever Taylor J, Migliorini M, Picard R, Cruz M, Regalia G. Prospective clinical validation of the Empatica EmbracePlus wristband as a reflective pulse oximeter. Front Digit Health. 2023 Dec 4;5:1258915. doi: 10.3389/fdgth.2023.1258915. eCollection 2023. |
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