Philips FAST SpO2 Technology for Oxygen Saturation

Recruiting at 1 trial location

Overseen By Chelsea Frank

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Masimo Corporation

Disqualifiers: Skin conditions, Limb deformities, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new method to measure blood oxygen levels in babies and children using special sensors from Masimo, linked to Philips monitors. The researchers aim to compare the effectiveness of this new setup with a standard FDA-approved device. Children under 22 years old without skin conditions that might interfere with sensor fit are eligible for this study. As an unphased trial, it provides an opportunity to contribute to innovative research that could enhance monitoring technology for young patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this technology is safe for neonatal, infant, and pediatric populations?

Research has shown that Masimo sensors, when paired with the Philips FAST SpO2 Algorithm, usually provide accurate and reliable blood oxygen readings. RD SET sensors, in particular, are known for their superior accuracy and comfortable design. However, some reports have noted failures in Masimo cables, leading to incorrect, low blood oxygen readings and resulting in unnecessary treatments and signal interruptions. This indicates that while the sensors are generally dependable, occasional issues can arise.

It is important to note that this study does not test a new drug or treatment but rather a monitoring technology. The aim is to ensure it functions well and accurately with devices already approved by the FDA. Overall, Masimo sensors are widely used in medical settings, indicating a level of safety and trust in their use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Philips FAST SpO2 technology because it offers a new way to measure blood oxygen levels using Masimo Sensors connected to Philips Monitors. Unlike standard pulse oximeters, which are typically used in hospitals and clinics, this setup employs a specialized algorithm for potentially quicker and more accurate readings. The innovation lies in the Philips FAST SpO2 Algorithm, which could enhance the reliability and speed of oxygen saturation measurements, making it particularly beneficial for patient monitoring in critical situations.

What evidence suggests that the Philips FAST SpO2 Technology is effective for oxygen saturation monitoring?

Studies have shown that Masimo SET® pulse oximetry accurately measures blood oxygen levels for people of all skin tones, meeting FDA standards. Compared to other technologies, Masimo SET® missed 93% fewer real alarms. In this trial, all participants will use Masimo Sensors connected to Philips Monitors with the Philips FAST SpO2 algorithm. This combination has proven to measure oxygen levels accurately and is now considered a new standard of care, providing precise and reliable results. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for newborns, infants, and children who need their oxygen levels monitored. It's testing how well Philips monitors work with Masimo sensors on patients with different skin colors. Patients must be in the age group that these sensors are meant for.

Inclusion Criteria

Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor

I am under 22 years old.

Exclusion Criteria

Confounders of pulse oximetry per sensor direction for use (DFU)

Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied

Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants undergo SpO2 monitoring using Masimo Sensors connected to Philips Monitors and an FDA-cleared pulse oximeter

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Masimo Sensor

Trial Overview The study is checking if Philips FAST SpO2 technology works correctly when connected to Masimo neonatal, infant, and pediatric sensors. They're comparing it to an already approved pulse oximeter across diverse patient skin tones.

How Is the Trial Designed?

Group I: Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm Experimental Treatment 1 Intervention

All subjects are enrolled into this arm. All subjects will have blood oxygen measurements from: * non-invasive Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm for blood oxygen measurements and * Masimo RD SET sensors connected to FDA-cleared pulse oximeter

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

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. masimo.com masimo.com/media/in-feasibility-study-for-large-prospective-real-world-trial-masimo-set-r-performed-accurately-on-critically-ill-adult-icu-patients-of-all-skin-tones

In Feasibility Study for Large, Prospective, Real-World Trial ... In this dataset, they found that Masimo SET® pulse oximetry was accurate among patients of all skin tones—well within FDA specifications for ...

3. transformingpatientcare.com transformingpatientcare.com/globalassets/documents/pdf/news/breakthroughcover070702.pdf

Masimo SET: Breakthrough Technology 1.1. Summary. Masimo SET® performance is the new standard of care and provides a new and fundamentally distinct method of acquiring, processing and ...

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

SET Pulse Oximetry Competitor pulse oximetry technology demonstrated 43% missed true alarms while Masimo SET® demonstrated 3% (93% reduction).10; There was a 82% reduction in ...

5. documents.philips.com documents.philips.com/assets/20240123/4d8a39e19cdc484ab75bb10000a02b35.pdf

Validation of Philips FAST SpO2 measurement accuracy This Application Note discusses the validation of the Philips. FAST SpO2 measurement accuracy and the detailed results of the.

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=25417

Medsun Reports - FDA Masimo told us the probes were compatible but we found out that the DBI sensors have not been tested against Philips Fast SPO2 algorithm. the device(s) may ...

7. masimo.com masimo.com/products/sensors/rd-set/

RD SET Sensors RD SET sensors feature improved SpO2 accuracy, a lightweight, comfortable design, and come in fold-over and wrap-around styles with improved connection.

8. 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.

9. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=11214182&pc=DQA

MAUDE Adverse Event Report: MASIMO CORPORATION The report details Masimo cable failures causing incorrect, low spo2 readings, leading to unnecessary therapy, and signal dropouts.

10. masimo.com masimo.com/products/sensors/lncs/

LNCS Sensors Masimo Trauma and Newborn sensors automatically enable Masimo SET® and rainbow SET™ devices to the fastest SpO2 and pulse rate readings at maximum sensitivity ...