Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
72 participants
OBSERVATIONAL
2025-10-28
2026-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TEST GROUP 1
Sensor Test Group 1
* AlarX4 (nasal ala placement)
* AlarX4 (earlobe placement)
* M1131AX1
* M1191BL - As Philips internal silver reference only
NO INTERVENTION
NO INTERVENTION
TEST GROUP 2
Sensor Test Group 2
* M1133AX5
* M1133AX6
* M1191BL - As Philips internal silver reference only
NO INTERVENTION
NO INTERVENTION
Interventions
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NO INTERVENTION
NO INTERVENTION
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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 as identified in the Health Assessment Form
* 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)
* cancer requiring chemotherapy, radiation, or current treatment
* Participants with known clotting disorders (selfreported)
* 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 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 in health assessment form
18 Years
50 Years
ALL
Yes
Sponsors
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Philips Clinical & Medical Affairs Global
INDUSTRY
Responsible Party
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Principal Investigators
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Monica Rabanal, NP
Role: PRINCIPAL_INVESTIGATOR
Element Desaturation Lab
Locations
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Element Materials Technology
Louisville, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CC-2025-301078-FAST 2025
Identifier Type: -
Identifier Source: org_study_id
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