SPO2 VALIDATION STUDY - PHILIPS FAST 2025 (NCT07221526) | Clinical Trial Compass
CompletedNot Applicable
SPO2 VALIDATION STUDY - PHILIPS FAST 2025
United States86 participantsStarted 2025-10-28
Plain-language summary
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants accepted into this study must meet all of the following criteria: Participant must have the ability to understand and provide written informed consent
* Participant is an adult between 18-50 years of age
* Participant must be willing and able to comply with study procedures and duration
* Participant is a non-smoker or who has not smoked within 2 days prior to the study
Exclusion Criteria:
* Participant is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos (e.g. permanent, Henna) or artificial dyes (e.g. spray tan, artificial tanning lotion) in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
* Females who are pregnant
* Females who are trying to get pregnant with confirmation of positive urine pregnancy test
* Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
* Participants with known respiratory conditions such as: (self-reported)
* uncontrolled / severe asthma
* flu
* pneumonia / bronchitis
* short…