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HealthyNCT06148623

Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation

A study testing Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in people with Healthy, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
13 Nov 2023to 14 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject is 18 to 50 years of age.
  • 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.
  • Hemoglobin value ≥ 11 g/dL.
  • CO value ≤ 3.0% FCOHb.
Show all 38Show fewer
  • Subject can read and communicate in English and understands the study and the risks involved.
  • Exclusion Criteria (Ineligible Subjects) ( = per clinician discretion):
  • Subject is pregnant or breastfeeding.
  • Subject has a BMI > 35.
  • Subject has a history of fainting (vasovagal syncope), blacking out or losing consciousness during or after a blood draw, or has a fear of blood draws.
  • Subject has open wounds, inflamed tattoos, or piercings, and/or has any visible healing wounds that a medical professional determines may place them at an increased risk for participation. *
  • Subject has finger deformities, nail deformities, nail polish, and/or gel/acrylic that can interfere with study device placement. *
  • Subject has known drug or alcohol abuse.
  • Subject uses recreational drugs. *
  • Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
  • Subject has experienced a concussion or head injury with loss of consciousness within the past 12 months.
  • Subject has any history of a stroke, myocardial infarction (heart attack), and/or seizures.
  • Subject has any chronic bleeding disorder (e.g., hemophilia).
  • Subject has taken anticoagulant medication within the past 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDs)).
  • Subject has donated blood within the past 4 weeks.
  • Subject has any cardiac dysrhythmia (e.g., atrial fibrillation) and has not received clearance from their physician to participate.
  • Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. *
  • Subject has taken opioid pain medication 24 hours before the study.
  • Subject has any infectious disease (e.g., Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles). *
  • Subject is taking medications known to treat any type of infectious disease.
  • Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
  • Subject has had invasive surgery within the past year, including but not limited to major dental surgery, appendectomy, plastic surgery, jaw surgery, major ENT surgery, major abdominal and/or pelvic surgery, heart surgery, or thoracic surgery. *
  • Subject has symptoms of congestion, head cold, or other illnesses.
  • Subject has been in a severe car accident(s) or a similar type of accident(s) requiring hospitalization within the past 12 months.
  • 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.
  • Subject is allergic to lidocaine, chlorhexidine, latex, adhesives, or plastic.
  • Subject has a heart condition, insulin-dependent diabetes, uncontrolled hypertension, or hypercholesterolemia.
  • Subject delivered vaginally, had a pregnancy terminated, had a miscarriage with hospitalization, or had a C-section within the past 6 months.
  • Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis), exercise (e.g., working out, riding a bike, riding a skateboard), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
  • Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
  • Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Masimo Corporation

    Irvine, California, 92618

Other trials in United States

About this study

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.

Conditions
Healthy
Being tested
Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Philips FAST SpO2 with Masimo Pulse Oximetry SensorsDevice

    Noninvasive pulse oximeter

Study groups in NCT06148623
Study groupRoleWhat they receive
Test SubjectExperimentalAll subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
Receives: Device: Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  2. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  3. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  4. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  5. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  6. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

  7. Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)

    The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.

    Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.

    Participants in this arm could receive one or more sensor types used for data collection.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start13 Nov 2023
  3. Primary completion14 Jan 2025
  4. Study completion14 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06148623
Sponsor's protocol ID
CIP-1088
Status last verified
Mar 2026
First submitted
20 Nov 2023
Last updated
2 Apr 2026
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in people with Healthy, run by Masimo Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt) (time frame: 1 hour). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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