At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus
In Brief
A clinical study evaluating Pulse oximeter accuracy under hypoxic conditions for Hypoxia. Completed, enrolled 163 participants across 1 site.
Detailed Summary
This study tests the accuracy of pulse oximeters in a range of arterial oxygen levels from 100% down to 70%. This is done by comparing the test pulse oximeter readings of young, healthy, adult study participants with blood samples drawn from an artery in the wrist during brief plateaus of progressively lower oxygen saturations. The arterial blood sample is processed in a device called a multi-wavelength hemoximeter and compared to the simultaneous oximeter reading. During each set level of oxygen the participant may be asked to have a motion simulator device apply different types of movement to their hands to assess the pulse oximeter's accuracy during motion. This study will be evaluating the Owlet OSS 3.0 sensor, a component in 2 FDA cleared noninvasive pulse oximeters indicated for infants 1-18 months of age. Testing should require approximately an hour and 15 minutes of the participant's time.
Study Details
Timeline
Interventions
This study will specifically evaluate the accuracy of the Owlet pulse oximeter sensor, currently FDA cleared for infants 1-18 months of age in an expanded hypoxia lab trial.