University of California at San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT05322382
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia.
Other names: Hypoxemia
Time frame: 2 days
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
CardiacSense Ltd.
Industry
Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
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