Philips FAST SpO2 Performance Across Skin Tones

Overseen By Ahmed Alghazi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Masimo Corporation

Must not be taking: Anticoagulants, Opioids, Infectious disease meds

Disqualifiers: Pregnancy, BMI > 35, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new device, Philips FAST SpO2 with Masimo Pulse Oximetry Sensors, measures blood oxygen levels in people with different skin tones. The device uses a sensor to check if it can accurately measure oxygen in the blood. The trial seeks participants who weigh at least 110 pounds, have a normal heart rate, and can read and speak English. The study aims to ensure the device works effectively for everyone, regardless of skin color.

As an unphased trial, this study offers a unique opportunity to contribute to research ensuring medical devices are effective for all skin tones.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken anticoagulants in the past 30 days or opioid pain medication 24 hours before the study. Also, you cannot be taking medications for infectious diseases.

What prior data suggests that this device is safe for use across different skin tones?

Research has shown that Philips FAST SpO2 technology, used with Masimo Pulse Oximetry Sensors, is safe for people. The FDA has approved these sensors, confirming they meet key safety standards for medical devices.

The Masimo sensors provide accurate readings even with interference from surrounding light and electronic devices, making them effective in various settings. Philips employs a wrap design that doesn't require adhesive, reducing the risk of skin irritation, particularly for those with sensitive skin.

No specific evidence of serious side effects has emerged with this technology. Since this trial is not in an early testing phase, the technology has likely passed several safety checks. Overall, based on past use and FDA approval, the technology appears safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Philips FAST SpO2 technology because it promises more accurate blood oxygen level readings across different skin tones, addressing a known issue with existing pulse oximetry devices. Traditional pulse oximeters can sometimes provide less accurate readings for individuals with darker skin tones due to how light is absorbed and reflected. The Philips FAST SpO2, combined with Masimo Pulse Oximetry Sensors, aims to overcome these limitations, ensuring consistent and reliable measurements for everyone. This advancement is crucial for improving patient care and monitoring across diverse populations.

What evidence suggests that this device is effective for measuring SpO2 across different skin tones?

Research has shown that the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors accurately measures blood oxygen levels across different skin tones. One study found that Masimo's technology performs well for patients with various skin colors. This is crucial because it reduces errors in oxygen level readings, which can sometimes occur in people with darker skin. Early results from other trials suggest the technology is accurate for diverse groups. This focus on inclusivity may make the Philips FAST SpO2 a reliable tool for measuring blood oxygen levels in a wide range of people. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-50, weighing at least 110 lbs, with stable heart rate and blood pressure. Participants must have normal hemoglobin levels, not be pregnant or breastfeeding, and free from certain medical conditions like stroke or heart attack. They should not have a fear of blood draws or any skin issues that could affect the sensor's placement.

Inclusion Criteria

Subject weighs a minimum of 110 lbs

Baseline heart rate ≥ 45 bpm and ≤ 90 bpm

Blood Pressure: Systolic BP ≤ 140 mmHg and ≥ 90 mmHg, Diastolic BP ≤ 90 mmHg and ≥ 50 mmHg, and if systolic BP is lower than 100 mmHg and/or diastolic BP is lower than 60 mmHg, subject passes an orthostatic blood pressure test

Exclusion Criteria

Subject is pregnant or breastfeeding

Subject has any cancer or history of cancer (not including skin cancer)

Subject has chronic unresolved asthma, lung disease (including COPD) and/or respiratory disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Data Collection

Participants undergo testing with Philips FAST SpO2 and Masimo Pulse Oximetry Sensors to measure oxygen saturation

1-3 hours

1 visit (in-person)

Follow-up

Participants are monitored for any immediate adverse effects post data collection

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

Trial Overview The Philips FAST SpO2 system paired with Masimo Pulse Oximetry Sensors is being tested to see how well it measures oxygen saturation in the blood across different skin tones compared to a standard reference method.

How Is the Trial Designed?

Group I: Test Subject Experimental Treatment 1 Intervention

All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

Who Is Running the Clinical Trial?

Masimo Corporation

Lead Sponsor

Trials

117

Recruited

13,500+

Katie Szyman

Masimo Corporation

Chief Executive Officer

BA from the University of St. Thomas, MBA from Harvard Business School

Dr. Bilal Muhsin

Masimo Corporation

Chief Medical Officer since 2024

MD from Harvard Medical School

Published Research Related to This Trial

The Masimo RD SET® pulse oximeter demonstrated no significant differences in accuracy between Black and White subjects during a controlled desaturation protocol, indicating it can be reliably used across different skin tones.

Occult hypoxemia was extremely rare in the study, occurring in only 0.2% of White subjects and not at all in Black subjects, suggesting that the device effectively detects low oxygen levels without bias related to skin pigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Racial effects on Masimo pulse oximetry: a laboratory study. Barker, SJ., Wilson, WC.[2023]

Masimo Signal Extraction Technology (SET) pulse oximetry improves the accuracy of oxygen saturation measurements during challenging conditions, such as patient motion and poor blood flow, by using advanced techniques like digital signal processing and adaptive filtration.

Unlike conventional pulse oximeters that may give erroneous readings during motion, Masimo SET identifies and isolates different saturation components, ensuring that the highest oxygen saturation value is reported, which enhances the reliability of SpO2 monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Masimo signal extraction pulse oximetry. Goldman, JM., Petterson, MT., Kopotic, RJ., et al.[2019]

Masimo SET pulse oximetry, which uses advanced signal extraction technology, shows over 95% sensitivity and specificity in accurately measuring arterial oxygen saturation even under challenging conditions like patient motion and low perfusion.

This new technology significantly reduces false alarms caused by motion artifacts and low perfusion from up to 90% to less than 5%, improving patient monitoring reliability in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive filtering and alternative calculations revolutionizes pulse oximetry sensitivity and specificity during motion and low perfusion. Graybeal, JM., Petterson, MT.[2020]

In a study involving 9 extremely low-birth-weight infants, pulse oximeters from three different brands showed a median difference in oxygen saturation readings of 2%, indicating variability in measurements.

The study suggests that the handling and positioning of pulse oximeter probes are more critical to measurement accuracy than the brand itself, highlighting the need for improved techniques in monitoring oxygen levels in these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"New-generation" pulse oximeters in extremely low-birth-weight infants: how do they perform in clinical practice? van der Eijk, AC., Horsch, S., Eilers, PH., et al.[2012]

In a study comparing 20 pulse oximeters during patient motion and hypoxemia, the Masimo SET(R) pulse oximeter showed the best performance, accurately reading SpO2 levels 94% of the time compared to control measurements.

Recent advancements in pulse oximeter technology have greatly enhanced their accuracy during motion, with older models like the Criticare 5040 performing significantly worse at only 28% accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Motion-resistant" pulse oximetry: a comparison of new and old models. Barker, SJ.[2019]

The Masimo SET pulse oximeter significantly reduced false alarms by 86% compared to the conventional Nellcor device, leading to 92% less total alarm time and better identification of true bradycardia events.

In a study involving 26 NICU infants, Masimo SET demonstrated superior performance in tracking heart rate changes and detecting hypoxic events, suggesting it could enhance clinician confidence and potentially reduce complications associated with oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of conventional and new pulse oximetry in neonatal patients. Hay, WW., Rodden, DJ., Collins, SM., et al.[2016]

In a study involving 75 children monitored for an average of 35 minutes each, Masimo Signal Extraction Technology (SET) was able to identify all true alarms (27 total) compared to only 59% detection by conventional pulse oximetry (CPO).

Masimo SET significantly reduced the number of false alarms (10 with CPO vs. 4 with Masimo SET), suggesting it is more reliable for monitoring oxygen levels in children post-anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False alarms and sensitivity of conventional pulse oximetry versus the Masimo SET technology in the pediatric postanesthesia care unit. Malviya, S., Reynolds, PI., Voepel-Lewis, T., et al.[2019]

In a study involving 11 preterm infants in a Neonatal Intensive Care Unit, both the Nellcor OXIMAX and Masimo SET SmartPod pulse oximeters showed similar performance metrics, indicating no significant difference in their ability to measure arterial oxygen saturation and pulse rate.

Despite both devices having high false alarm rates, the differences in their sensitivity and accuracy were not statistically significant, suggesting that both technologies may contribute to alarm fatigue in the NICU without providing clear advantages over one another.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance Evaluation of New-Generation Pulse Oximeters in the NICU: Observational Study. Nizami, S., Greenwood, K., Barrowman, N., et al.[2015]

In a study involving 25 anesthetized rabbits with induced pneumonia/sepsis, both Masimo SET and Nellcor Oxismart XL pulse oximetry devices effectively measured oxygen saturation during low perfusion, indicating their sensitivity in critical conditions.

However, the Masimo SET device had fewer instances of false oxygen saturation readings compared to the Oxismart XL, suggesting it may provide more reliable measurements in sepsis-induced low perfusion scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry readings in an animal model of low perfusion caused by emerging pneumonia and sepsis. Hummler, HD., Engelmann, A., Pohlandt, F., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223177

Philips FAST SpO2 Technology With Masimo Sensors for ... The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient ...

2. investor.masimo.com investor.masimo.com/news/news-details/2025/In-Feasibility-Study-for-Large-Prospective-Real-World-Trial-Masimo-SET-Performed-Accurately-on-Critically-Ill-Adult-ICU-Patients-of-All-Skin-Tones/default.aspx

In Feasibility Study for Large, Prospective, Real-World Trial ... Although not yet definitive, our preliminary results suggest that Masimo SET® performs accurately on all skin tones.” Daniel Cantillon, M.D., ...

3. withpower.com withpower.com/trial/phase-healthy-subjects-hs-10-2023-75777

Philips FAST SpO2 Performance Across Skin Tones The Philips FAST SpO2 treatment is unique because it focuses on improving the accuracy of oxygen saturation measurements across different skin tones, addressing ...

4. trialx.com trialx.com/clinical-trials/listings/228449/clinical-performance-testing-of-philips-fast-spo2-with-masimo-pulse-oximetry-sensors-across-skin-pigmentation/

Clinical Performance Testing of Philips FAST SpO2 With ... Clinical trial for Healthy , Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation.

5. fda.gov fda.gov/media/175828/download

FDA Executive Summary Performance Evaluation of Pulse ... looking at pulse oximetry accuracy for adults with a variety of skin tones. They concluded that “a review of relevant literature indicates a ...

6. documents.philips.com documents.philips.com/assets/20250210/64a30873c01245d3bb7cb28001801c43.pdf

FAST SpO Algorithm This application note describes the principles of Pulse Oximetry technology in general, and the Philips FAST SpO2 algorithm used.

7. usa.philips.com usa.philips.com/healthcare/supplies/pulse-oximetry

Pulse oximetry The Philips M1134A adhesive-free, single-patient wrap pulse oximetry sensor is designed to protect delicate skin while delivering a high-quality signal.

8. masimo.com masimo.com/technology/pulse-oximetry/masimo-set-pulse-oximetry/

SET Pulse Oximetry Masimo SET® sensors and cables are designed to shield themselves from external electromagnetic and ambient light interference to provide optimal performance.

9. philips.sa philips.sa/en/healthcare/resources/landing/masimo/rainbow-set-technology

Masimo & Patient Monitoring | Philips Advanced rainbow SET sensors utilize multiple wavelengths of light to measure total hemoglobin (SpHb), Pleth Variability Index (PVi), oxygen content (SpOC).