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The primary objective of the study is to validate the proposed claims for the OxiCable device, for pulse rate and saturation accuracy in a diverse subject population over a specified saturation range.
The general procedure of invasive controlled hypoxia clinical studies is to directly compare test pulse oximeter measurements to saturation measurements made by a multi-wavelength CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples at targeted levels of saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse Oximeter (the device) | The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 20 subjects recruited from the Clinical Laboratory subject data base.
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| Name | Affiliation | Role |
|---|---|---|
| Eric T Heyer, MD | Medtronic - MITG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder Clinical Laboratory | Boulder | Colorado | 80301 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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