Accuracy Of The Owlet OSS 3.0 During Standardized Stable Hypoxia Plateaus

Study 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.

Primary Outcome

* Overall Accuracy: Arms is less than 3%. * Non-Disparate Performance Evaluation 1: Among pairwise comparisons of MST groups 1-4, 5-7, and 8-10, the largest difference in SpO2 bias is less than 3.5% for the interval 70% ≤ SaO2≤ 85% and less than 1.5% for 85%\< SaO2 ≤ 100%. * Non-Disparate Performance Evaluation 2: For a 100-point change in emitter sensor site ITA, the difference in SpO2 bias is less than 3.5% for 70% ≤ SaO2≤ 85% and less than 1.5% for 85%\< SaO2 ≤ 100%

Conditions Studied

Interventions

• DIAGNOSTIC_TEST Pulse oximeter accuracy under hypoxic conditions

Study Locations (1)