Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation
- Conditions
- Healthy
- Interventions
- Device: Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
- Registration Number
- NCT06148623
- Lead Sponsor
- Masimo Corporation
- Brief Summary
Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test Subject Philips FAST SpO2 with Masimo Pulse Oximetry Sensors All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
- Primary Outcome Measures
Name Time Method Oxygen saturation performance of Philips FAST SpO2 with Masimo pulse oximetry sensors 1-3 hours Performance will be determined by calculating the average root mean square (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.
- Secondary Outcome Measures
Name Time Method Difference in oxygen saturation performance between three population subgroups 1-3 hours Average root mean square (ARMS) will be computed for each pigmentation subgroup for light, medium, and dark skin pigmentation and the difference between the subgroup ARMS will be calculated.
Trial Locations
- Locations (1)
Masimo Corporation
🇺🇸Irvine, California, United States