SpO2 Verification Study - Philips Nasal Alar With Nellcor OxiMax SpO2 Board (453564624031)

The primary purpose of the clinical investigation is to verify the SpO2 accuracy of the Philips AlarX5 SpO2 sensor with Nellcor OxiMax SpO2 Board.

Study Overview

• Status: Recruiting
• Conditions: Pulse Oximetry
• Intervention / Treatment: Other: Evaluation of Oxygen Sensors

Detailed Description

To verify the SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) with the Nellcor OxiMax pulse oximetry technology during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.

• Study Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Dominque Watson; Phone Number: 724-334-3117; Email: Dominque.Watson@philips.com

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Recruiting
      • Element Materials Technology
      • Principal Investigator: Monica Rabanal, NP
      • Contact: Monica Rabanal, NP; Phone Number: 303-926-5432; Email: monica.rabanal@element.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will include a minimum of 36 to 72 healthy adult volunteers.

Description

Inclusion 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, 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy Volunteers; Participants are healthy, non-smoking (or has refrained from smoking for 2 days) competent adults, ages 18 to 50 years.

Other: Evaluation of Oxygen Sensors; The experimental Philips AlarX5 SpO2 sensor will be tested with Nellcor OxiMax pulse oximetry technology. The AlarX5 SpO2 sensor will be connected via an adapter cable to an IntelliVue X3 Patient Monitor integrated with a Nellcor OxiMax SpO2 Board. Within the study, biomedical/health related outcomes as it relates to the healthy volunteers are not evaluated. The data collected will be used to evaluate how accurate the pulse oximeter (DUT) is to the reference. Devices under test are listed below: Nellcor OxiMax SpO2 Board (453564624031) integrated within Philips IntelliVue X3 Patient Monitor (867030); Philips AlarX5, Experimental SpO2 sensor based on the Nasal Alar design (nasal ala and earlobe placement); Philips M1943NL SpO2 Adapter Cable (3m)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.	Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (nasal ala application) compared to arterial oxygen saturation.	Up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (earlobe placement) during non-motion conditions.	Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (earlobe placement) during non-motion conditions.	Up to 6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the pigmentation bias of the AlarX5 SpO2 sensor (nasal ala and earlobe application).	Non-disparate performance for the AlarX5 SpO2 sensor.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2026
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SEF-2025-301123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is currently under consideration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No