SpO2 Validation Study-Philips Optimus

NCT07215429 | Terminated FDA Device

• 1 other identifier: Protocol # PR 2024-608_300178
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Validation study 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

Conditions

Pulse Oximetry, Oxygen Measurements, SpO2

Outcome Measures

Primary Outcomes (1)

• SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring

  Pulse Oximetry Subsystem 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.

  Day 1

Secondary Outcomes (1)

• evaluate non-disparate performance (differential bias) of the SpO2 sensors under test

  Day 1

Study Arms (4)

Philips Wireless Patient Module SpO2 (Gen-4)

This device is a complete pulse oximeter measurement module that utilizes the Philips PicoSAT II+ SpO2 processor that is a component on the circuit car assembly, part number 453665151651. This processor incorporates all signal processing and algorithms to derive the oxygen saturation value (SpO2), pulse rate, perfusion indicator value, and the plethysmographic waveform

Device: No intervention

SpO2 Sensor, MRI (Gen-4)

This is a fiber-optic cable that is attached via an connector at one end to the Philips Wireless SpO2 Patient Module, and one of the SpO2 finger accessories at the other end. This cable serves as the conduit through which red and infrared light is transmitted into the finger and then is received back from the other side of the finger into the photodiode. The red and infrared LEDs and the photodiode are all contained in the cable housing. The cable itself is made from RoHS-compliant fiber-optic materials. Fiber-optics are utilized to allow the SpO2 module to operate properly in the MRI environment.

Device: No intervention

SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable)

The SpO2 Grips and Gloves are designed to securely hold the SpO2 Sensor in proper location when it is attached to the Wireless SpO2 module. Both finger accessories provide two slide-in clip attachments for connecting to the SpO2 Cable ends, designed to be positioned at the top and bottom of the finger. The reusable finger accessory is designed to slide onto the finger and secure itself by means of a rubber-like material that provides the appropriate grip

Device: No intervention

Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL)

The IntelliVue X3 is a versatile patient monitoring device with a color touchscreen display. It can simultaneously monitor ECG (using 3-, 5-, 6- or 10-lead sets, including arrhythmia and ST monitoring), respiration, SpO2, NBP, two invasive pressures, temperature, and CO2. The multi-touch screen allows easy interaction by swiping and tapping with one or two fingers.

Device: No intervention

Interventions

No intervention DEVICE

No intervention

Philips Wireless Patient Module SpO2 (Gen-4); Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL); SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable); SpO2 Sensor, MRI (Gen-4)

Eligibility Criteria

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

Study Population

minimum of 66 participants up to a maximum of 180, healthy male and female volunteers of any race, ranging in pigmentation from light to dark. he study population will meet the following stratification criteria: * At least 25% of the population with Monk 1-3 with ITA \> 30 at the forehead * At least 25% of the population with Monk 4-7 with ITA ≤ 30 and ≥ -30 at the forehead * At least 25% of the population with Monk 8-10 with ITA \< -30 at the forehead * At least half of the participants in this group will have an ITA \< -50 at the forehead * In the event the Monk and ITA place a participant in different cohorts, the ITA shall be used to determine the demographic cohort for the participant * At least 40% of the population male * At least 40% of the population female

You may qualify if:

• Participants accepted in this study must meet all the following 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.

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, 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)
• 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 or without hospitalization (last 2 months)
• 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 Officials

• Monica Rabanal, NP

  Element Desaturation Labratory

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 10, 2025
• Study Start: September 9, 2025
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)