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

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.

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.

Is the Philips FAST SpO2 technology safe for use in humans?

The studies indicate that the Masimo SET technology, which is part of the Philips FAST SpO2 system, is generally safe and performs well in various conditions, including during patient motion and in neonatal care. However, there are high false alarm rates, which could lead to alarm fatigue in clinical settings. ^{1 2 3 4 5}

How does the Philips FAST SpO2 treatment differ from other pulse oximetry technologies?

The Philips FAST SpO2 treatment is unique because it focuses on improving the accuracy of oxygen saturation measurements across different skin tones, addressing a known limitation in conventional pulse oximetry. This is particularly important as traditional pulse oximeters have been shown to be less accurate in individuals with darker skin tones. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Philips FAST SpO2 with Masimo Pulse Oximetry Sensors?

Research shows that the Masimo SET pulse oximeter, which is part of the treatment, has demonstrated high accuracy and reliability, especially during patient motion, with a performance index of 94% in maintaining accurate oxygen saturation readings. This suggests that the treatment may be effective in providing reliable oxygen level measurements across different conditions. ^{1 2 4 6 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

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]

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]

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 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]

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 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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Reliability of conventional and new pulse oximetry in neonatal patients. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Masimo signal extraction pulse oximetry. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

False alarms and sensitivity of conventional pulse oximetry versus the Masimo SET technology in the pediatric postanesthesia care unit. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Accuracy of pulse oximetry readings in an animal model of low perfusion caused by emerging pneumonia and sepsis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

"New-generation" pulse oximeters in extremely low-birth-weight infants: how do they perform in clinical practice? [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Performance Evaluation of New-Generation Pulse Oximeters in the NICU: Observational Study. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Adaptive filtering and alternative calculations revolutionizes pulse oximetry sensitivity and specificity during motion and low perfusion. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Racial effects on Masimo pulse oximetry: a laboratory study. [2023]