SpO2 Validation Study-Philips Optimus

Stopped early

Conditions studied: Pulse Oximetry, Oxygen Measurements, SpO2

In brief

Validation study to validate the SpO2 accuracy performance of the Sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry

Key facts

Study ID

NCT07215429

Run by

Philips Clinical & Medical Affairs Global

People needed

24

Starts

2025-09-09

Expected to finish

2025-09-19

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants accepted in this study must meet all 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.

You may not qualify if…

• Participant is considered as being morbidly obese (defined as BMI >39.5)
• Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, 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 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 unless the participant is known to be not of child-bearing potential)
• 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,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery,
• emphysema, COPD, lung disease
• Recent COVID with or without hospitalization (last 2 months)
• Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
• high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen)
• have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke
• transient ischemic attack
• carotid artery disease

Where it is running

• Element Materials Technology — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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