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This study will collect physiological measurements in healthy adult volunteers under controlled hypoxia and hemodilution conditions.
Subjects will undergo stepwise reductions in oxygen saturation and hemoglobin concentration while noninvasive monitoring data are recorded and compared with reference blood measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult healthy subjects | Adult healthy subjects capable of undergoing controlled hypoxemia and hemodilution procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive Physiological Monitoring Device | Device | Octopal R Noninvasive Pulse Wave Measuring Device DMO-8000X with TL 811S Finger Probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collection of Hemoglobin and Oxygen Saturation Measurements | Collect device readings of oxygen saturation and hemoglobin concentration and reference values obtained from arterial blood samples analyzed using a multi-wavelength laboratory oximeter. | From enrollment to the end of treatment up to 8 hours |
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Inclusion Criteria:
4. Has provided written informed consent and is willing to comply with study procedures.
Exclusion Criteria:
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Healthy adult volunteers. At least 7 subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greg Stratmann, MD, PhD | Contact | (650) 868-5155 | stratman@anesthesia.ucsf.edu | |
| Steve Weisner, MS | Contact | 617-318-5904 | steve_weisner@nihonkohden.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vital Sign Research Group | San Francisco | California | 94107 | 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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