NEXT GEN - PHILIPS OPTIMUS
ConditionPulse Oximetry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorPhilips Clinical & Medical Affairs Global
About this trial
The purpose of this clinical study is 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Philips MR400 Pro MRI Patient Monitor
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov