SpO2 Validation Study - Philips FAST 2024

NCT06484452 | Completed FDA Device

• 1 other identifier: CC-300177-FAST 2024
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy

  Accuracy expressed in ARMS of SpO2 measurements obtained from the SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2, in comparision to SaO2 as ground truth.

  May-August 2024

Secondary Outcomes (1)

• Non-Disparate Bias

  May-August 2024

Study Arms (4)

Test Group 1

* M1131A (989803205831) * M1191T (989803128591) * M1191BL (989803144381) for endpoint analysis * M1193A (989803205881)

Device: No Intervention

Test Group 2

* M1194A (989803205891) * Alar (989803205381) * M1191BL (989803144381) as an internal reference only

Device: No Intervention

Test Group 3

* EX-Alar on Nasal Ala (Experimental) * EX-Alar on Ear (Experimental) * M1191BL (989803144381) as an internal reference only

Device: No Intervention

Test Group 4

* M1133A (989803205851) * EX-M1133A (Experimental) * M1196T (989803205911) * EX-M1196T (Experimental) * M1191BL (989803144381) as an internal reference only (optional)

Device: No Intervention

Interventions

No Intervention DEVICE

No Intervention

Test Group 1; Test Group 2; Test Group 3; Test Group 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

The study population for this protocol will include a minimum of 96 to a maximum of 120 healthy, competent adult male and female participants of any race and ranging in pigmentation from light to dark. Participants will be non-smoking (or have refrained from smoking for 2 days) and between the ages of 18-50 years old.

You may qualify if:

• Participant must have the ability to understand and provide written informed consent
• Participant is 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)
• Participants with compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears, nose, forehead/skull, or other sensor sites which would limit the ability to test sites needed for the study. Tattoo (e.g. permanent, Henna) or artificial dyes (including spray tan, pigmented 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 particular sites utilized.)
• Females who are pregnant, who are trying to get pregnant, (confirmed by 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 (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),
• have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA),

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: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: May 6, 2024
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)