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

Trial Summary

What is the purpose of this trial?

The objective of this study is to evaluate the performance of Masimo RD SET® SpO2 sensors in subjects with light and dark skin pigmentation in the intensive care therapeutic area.

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 data supports the idea that RD SET Sensor for Low Oxygen Levels is an effective treatment?

The available research shows that the Masimo RD SET Sensor is effective in situations where other pulse oximeters fail. For example, in a study with critically ill patients, the Masimo SET technology was able to accurately measure blood oxygen levels in 12 out of 13 patients, even when conventional pulse oximeters could not. This suggests that the RD SET Sensor is particularly useful in challenging conditions, such as when patients are moving or have poor blood flow, making it a reliable option compared to older technologies. ^{1 2 3 4 5}

What safety data exists for the RD SET Sensor for low oxygen levels?

The Masimo RD SET Sensor, also known as Masimo SET Pulse Oximeter, has been evaluated for its safety and effectiveness in various studies. The technology, known as Signal Extraction Technology (SET), has been tested extensively in both laboratory and clinical settings. It has shown high sensitivity and specificity, over 95%, even under challenging conditions such as patient motion and low perfusion. Clinical testing in hospital environments has validated its performance, significantly reducing false alarms due to motion artifact and low perfusion from up to 90% to less than 5%. This suggests that the RD SET Sensor is a reliable and safe option for monitoring blood oxygen levels, especially in critical care settings. ^{1 5 6 7 8}

Is the RD SET Sensor a promising treatment for low oxygen levels?

Yes, the RD SET Sensor is a promising treatment for low oxygen levels. It uses advanced technology to accurately measure blood oxygen levels, even in challenging conditions where other devices might fail. This can improve patient safety, especially in critical situations. ^{2 4 7 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

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

Pulse-oximetric measurement of prilocaine-induced methemoglobinemia in regional anesthesia. [2013]

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

Advantages of new technology pulse oximetry with adults in extremis. [2004]

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

Pulse oximetry during low perfusion caused by emerging pneumonia and sepsis in rabbits. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of finger and forehead pulse oximeters during mild hypothermic cardiopulmonary bypass. [2022]

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

Next-generation pulse oximetry. Focusing on Masimo's signal extraction technology. [2019]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Masimo signal extraction pulse oximetry. [2019]

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

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

9. United States 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. [2019]

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

Commercial smartwatch with pulse oximeter detects short-time hypoxemia as well as standard medical-grade device: Validation study. [2022]