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The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval.
The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).
Per FDA guidance, at least 2, or 15% of the subjects will have dark skin.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiree | Device | The aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). The data obtained is submitted by pulse oximeter manufacturers to the FDA for device approval |
| Measure | Description | Time Frame |
|---|---|---|
| To obtain a reading from the Respiree device that corresponds to the associated blood sample or a reference oximeter. | The number of subjects and the number of comparisons (paired pulse oximeter readings and arterial saturation values) is determined by current FDA guidance requirements. This is a minimum of 200 data points and 10 subjects. In the course of this type of study, some subjects may drop out, some readings can be lost due to motion or other interference and occasionally some do not consent. | 1 hour per subject |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the ISO 80601-2-61:2017).
Per FDA guidance, at least 2, or 15% of the subjects will have dark skin
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypoxia Research Laboratory | San Francisco | California | 94143 | United States |
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