RD SET Sensor for Low Oxygen Levels

Overseen By Chelsea Frank

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masimo Corporation

Disqualifiers: Skin conditions, Nail polish, Allergies, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sensor, the RD SET Sensor, to assess its accuracy in measuring oxygen levels across different skin tones. It focuses on individuals in intensive care with low oxygen levels, who may require supplemental oxygen or have difficulty obtaining sufficient oxygen naturally. Eligible participants must be in an intensive care unit, have an arterial catheter (a small tube) in place, and experience low oxygen levels. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance oxygen monitoring for diverse populations.

Do I have to stop taking my current medications for the trial?

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

What prior data suggests that the RD SET Sensor is safe for use in measuring low oxygen levels?

Research has shown that Masimo RD SET® sensors are generally safe and reliable for checking blood oxygen levels. Studies have found that these sensors work accurately for people with different skin tones, even in challenging situations like movement or low blood flow. This accuracy is crucial in medical settings where exact readings are essential.

The sensors use advanced technology to reduce false alarms, resulting in fewer unnecessary interruptions for patients. Available data has not reported any specific negative effects from using these sensors. Their widespread use in hospitals suggests they are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RD SET Sensor is unique because it offers a non-invasive way to measure blood oxygen levels, which is crucial for patients with conditions leading to low oxygen levels in the blood. Researchers are excited about this sensor because it utilizes advanced technology to provide more accurate and reliable SpO2 readings compared to traditional pulse oximeters. This could lead to better monitoring and management of patients with respiratory conditions, ensuring timely interventions and potentially improving outcomes.

What evidence suggests that the RD SET Sensor is effective for measuring low oxygen levels?

No edits are necessary because this trial includes only one treatment arm. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 in intensive care with low oxygen levels, who have an arterial catheter. It's not for those with unreliable pulse oximetry on certain fingers, skin pigmentation conditions like vitiligo, nail polish/acrylics where the sensor goes, allergies to adhesive tapes, lower extremity arterial catheters or specific skin conditions on their digits.

Inclusion Criteria

Subject with an arterial catheter in place

Subject is receiving care in an intensive care unit

I need extra oxygen or my oxygen levels are 94% or less without it.

Exclusion Criteria

Subjects in whom pulse oximetry cannot be reliably performed on both the third and fourth digit on the hand ipsilateral to the arterial line, precluding application of the sensor (e.g., amputation and deformity)

Subjects with distinct geographic variances in skin pigmentation (e.g., vitiligo) on the digit where the sensor is applied, which would preclude sensor placement as standard of care

Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Measurement

Participants will have SpO2 measurements obtained using Masimo RD SET sensors

Approximately 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after measurement

1 week

What Are the Treatments Tested in This Trial?

Interventions

• RD SET Sensor

Trial Overview The INSPIRE study is testing how well Masimo RD SET® SpO2 sensors measure blood oxygen levels in patients with different skin colors in the ICU. The goal is to see if skin pigmentation affects the sensor's accuracy.

How Is the Trial Designed?

Group I: RD SET Sensor Experimental Treatment 1 Intervention

All subjects are enrolled into this arm and will have Sp02 measurements obtained.

RD SET Sensor is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

Approved in European Union as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

Approved in Canada as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

Approved in Japan as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

Approved in China as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

Approved in Switzerland as RD SET Sensor for:

• Monitoring of oxygen saturation in adult and pediatric patients

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 Radical 7(®) pulse CO oximeter effectively measures methemoglobin levels, showing a mean bias of only 0.27% compared to traditional methods, indicating its accuracy.

In a study involving 360 data pairs, the Radical 7(®) demonstrated a high degree of agreement in methemoglobin measurement, suggesting it is a reliable tool for monitoring patients during regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse-oximetric measurement of prilocaine-induced methemoglobinemia in regional anesthesia. Soeding, P., Deppe, M., Gehring, H.[2013]

In a study of 13 critically ill patients in the ICU, the Masimo SET technology for pulse oximetry successfully determined arterial saturation in 12 cases where conventional pulse oximetry failed.

The use of Masimo SET technology significantly improved patient safety in challenging clinical situations, demonstrating its efficacy in monitoring oxygen levels in severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of new technology pulse oximetry with adults in extremis. Durbin, CG., Rostow, SK.[2004]

The Apple Watch Series 6 can accurately detect low blood oxygen levels (SpO2) below 90%, showing a small bias of only 1.2% compared to a medical-grade pulse oximeter during controlled breathing tests with 24 healthy participants.

This smartwatch technology is advanced enough to provide reliable SpO2 measurements outside of clinical settings, making it a useful tool for monitoring hypoxemia in everyday life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. Rafl, J., Bachman, TE., Rafl-Huttova, V., et al.[2022]

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 Corporation's Signal Extraction Technology (SET) represents a significant advancement in pulse oximetry, effectively addressing limitations of conventional devices, particularly in monitoring patients who are moving or have poor blood perfusion.

The study evaluated the performance of Masimo SET against traditional pulse oximeters, focusing on its ability to provide accurate readings under challenging conditions, which is crucial for ensuring patient safety, especially in critically ill and pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation pulse oximetry. Focusing on Masimo's signal extraction technology. [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]

The Masimo SET pulse oximeter demonstrated significantly less signal loss compared to the standard Nellcor N-200 pulse oximeter in a sepsis model involving 26 anesthetized rabbits, indicating better reliability during low perfusion conditions.

Both devices showed episodes of falsely low oxygen saturation readings, particularly as the animals' hemodynamics deteriorated, suggesting that caution is needed when interpreting pulse oximetry data in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse oximetry during low perfusion caused by emerging pneumonia and sepsis in rabbits. Hummler, HD., Pohlandt, F., Franz, AR.[2019]

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 27 patients, the Masimo SET and Nellcor N-395 pulse oximeters showed similar performance to the older GE Solar 8000 model under good signal conditions, but Masimo rejected less data as questionable than Nellcor.

However, during poor signal conditions or hypoxemia, the performance and agreement between the newer devices were not clinically equivalent, indicating that their data reporting can vary significantly under challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the effects of signal integrity and saturation on data availability and accuracy of Masimo SE and Nellcor N-395 oximeters in children. Robertson, FA., Hoffman, GM.[2019]

In a study of 20 adult patients undergoing cardiac surgery, the Nellcor N550 D-25 pulse oximeter showed the least failure rate in measuring oxygen saturation (SpO2) during peripheral hypoperfusion, indicating its effectiveness in challenging conditions.

The duration of pulse oximeter failure was significantly lower with the N-D compared to the other devices, suggesting it is the most reliable option for monitoring SpO2 during periods of low blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of finger and forehead pulse oximeters during mild hypothermic cardiopulmonary bypass. Yamaura, K., Irita, K., Kandabashi, T., et al.[2022]

Citations

1. investor.masimo.com investor.masimo.com/news/news-details/2024/New-Peer-Reviewed-Study-Finds-That-Masimo-SET-Pulse-Oximetry-Measures-Accurately-on-Both-Black-and-White-People-Even-During-Low-Perfusion/default.aspx

New Peer-Reviewed Study Finds That Masimo SET® ... New Peer-Reviewed Study Finds That Masimo SET® Pulse Oximetry Measures Accurately on Both Black and White People Even During Low Perfusion.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10995008/

Racial effects on masimo pulse oximetry: impact of low ... The data demonstrate that Masimo SET® pulse oximeters with RD SET® sensors are equally accurate when tested on healthy Black and White ...

3. 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 ... Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/82/NCT03831282/Prot_SAP_000.pdf

masimo The Radical 7 pulse CO-oximeter is a noninvasive patient monitor that continuously measures and monitors in real-time the oxygen saturation of arterial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11228211/

Randomised crossover study on pulse oximeter readings ... Mean SpO2 values were significantly lower with RD sensors (92.2% vs 94.0%; p<0.0001) and significantly higher with PPG sensors (94.5% vs 94.0%; ...

6. masimo.com masimo.com/products/sensors/rd-set/single-use/

RD SET Single-patient use Sensors RD SET Single-patient-use Sensors Featuring Masimo SET Measure-through Motion and Low Perfusion Technology

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223721.pdf

K223721 - accessdata.fda.gov Masimo SET pulse oximetry relies on the Beer-Lambert law and the following principles of pulse oximetry to provide estimates of functional ...

8. investor.masimo.com investor.masimo.com/news/news-details/2024/Masimo-SET-Pulse-Oximetry-Superior-Performance-Worldwide-Presence-Immeasurable-Impact/default.aspx

Masimo SET® Pulse Oximetry: Superior Performance, ... Masimo SET ® is accurate during motion. Before Masimo SET ® pulse oximetry, false alarm rates were high, 5,6 often due to motion 7,8 and low ...

9. boundtree.com boundtree.com/monitoring-diagnostics/pulse-oximetry-accessories/masimo-rd-disposable-sensors/p/group005545?srsltid=AfmBOormTfnuJFfZOo7S1XIRkNYY18BOBCOZ7FUI0zL95j2JsFCHz0KC

Masimo® RD Disposable Sensors Key Features: Advanced Signal Processing: RD sensors utilize Masimo's proprietary Signal Extraction Technology (SET®) for enhanced accuracy, particularly useful ...