Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation

Not Applicable

Active, not recruiting

• Conditions: Healthy

• 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

Study Timeline

• Study Start: 2023-11-13
• Study First Submitted: 2023-11-20
• Study First Submitted QC: 2023-11-20
• Study First Posted: 2023-11-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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