Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
Condition(s) studied
Investigational drug(s) / intervention(s)
Pulse Oximeter: OLV-4202 pulse oximeter ((SW version: 01-17)
Induced hypoxia through breathing nitrogen-air-carbon dioxide mixture: Subjects will be placed in a seated semi-reclined position. Subjects will breathe a nitrogen-air-carbon dioxide mixture to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia is obtained by breath-by-breath analysis of respiratory gas using a gas analyzer that permits the inspired gas mixture to be adjusted to achieve the desired degree of blood oxygen saturation. Study is observational to see response of pulse oximeter. Intervention (above) is not therapeutic, rather is simply used to vary oxygen levels in subjects.
Study summary
The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with healthy volunteers at rest.
Eligibility
Primary outcome measure(s)
- Accuracy of Sensor Oxygen Saturation by Arms Calculation — Up to 15 min
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2) to that obtained from a blood sample (SaO2) and calculating the arithmetic root mean square (Arms) error value as follows: Arms = Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Vital Sign Research Group | San Francisco | California |
More Nihon Kohden trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07408388 on ClinicalTrials.gov ↗ ← All trials in the USA