NCT07680530
SpO2 Verification Study - Philips Nasal Alar With Nellcor OxiMax SpO2 Board (453564624031)
Completed
Not specifiedAges 18–50ObservationalPhilips Clinical & Medical Affairs Global
~43 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Evaluation of Oxygen Sensors
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.
Measured over Up to 6 weeks
Conditions
Where it's being run
1 sites across 1 statesColorado1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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, hands, nose, 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
shortness of breath / respiratory distress
unresolved respiratory or lung surgery
emphysema, COPD, lung disease
recent COVID with hospitalization
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
myocardial ischemia
myocardial infarction
cardiomyopathy
implantable active medical device such as pacemaker or automatic defibrillator
Participants with self-reported health conditions
diabetes
uncontrolled thyroid disease
kidney disease / chronic renal impairment,
history of seizures (except childhood febrile seizures)
epilepsy
history of unexplained syncope
recent history of frequent migraine headaches
recent symptomatic head injury (within the last 2 months) with continued symptoms
cancer requiring chemotherapy, radiation, or current treatment - Participants with known clotting disorders (self reported)
history of bleeding disorders or personal history of prolonged bleeding from injury
history of blood clots
hemophilia
current use of blood thinner: prescription or daily use of aspirin
Sickle Cell Trait or Disease - Participants with self-reported dermatological conditions at sensor application sites
severe dermatitis
hyperkeratosis
nail fungus - Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self reported)
Participants with severe allergies to iodine (only applicable if iodine is used)
Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
Participants with allergies to ultrasound gel
Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio \<0.4)
Unwillingness or inability to remove nail polish, nail jewelry, or artificial nails from test digits. Bruised nail bed of test digits.
Unwillingness or inability to remove makeup, creams, lotions, sunscreen, or powders from application sites on the nose or ear.
Unwillingness or inability to cut/trim fingernail(s) of test digits if determined length will interfere with correct application of the sensor
Piercing at application site of the ear or nose sensors that may interfere with correct placement of sensor
Participants received colored intravascular dye within the past 48 hours (e.g. Indocyanine green, methylene blue, dyes used in cardiac output monitoring)
Surgical hardware in pathway of Device Under Test
Other known health conditions should be considered upon disclosure
What this trial measures
- Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.Up to 6 weeks
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.