Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
To validate SpO2 accuracy performance of various SpO2 sensors with the Philips FAST Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry
Study Type
OBSERVATIONAL
Enrollment
72
There is no intervention in this study
Clinimark
Louisville, Colorado, United States
Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053
Time frame: 13DEC2022-Q3 2023
Over 70-100% SpO2, an ARMS of ≤ 3% in non-motion conditions for the following SpO2 Sensors: 989803128591, 989803205881, 989803205891, 989803205911, 989803205831, 989803205381, MAXAI, MAXNI, OxySoftN, 4004, and 4052
Over 70-100% SpO2, an ARMS of ≤ 2% in non-motion conditions for the following SpO2 Sensors: 989803144381, 989803205851, 4000, 4050, and 2258 • Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter Over 70-100% SpO2, an ARMS within 1% among the broad categories of light, medium, and dark skin pigmentation for each SpO2 sensor under test Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter)
Time frame: 20DEC2022 - Q3 2023
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