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

NCT07680530 | Completed FDA Device

• 1 other identifier: SEF-2025-301123
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement and comparison of SpO2 accuracy of the AlarX5 SpO2 sensor (earlobe placement) during non-motion conditions.

  Up to 6 weeks

Other Outcomes (1)

• Evaluation of the pigmentation bias of the AlarX5 SpO2 sensor (nasal ala and earlobe application).

  Up to 6 weeks

Study Arms (1)

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

Interventions

Evaluation of Oxygen Sensors OTHER

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)

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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, 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)

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: July 2, 2026
• Study Start: May 28, 2026
• Primary Completion: June 29, 2026
• Study Completion: June 29, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)