CompletedNCT06148623Updated Apr 2, 2026Results posted

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

An interventional study of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Masimo Corporation · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 70
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.

Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Inclusion Criteria (Eligible Subjects):

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.
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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 70 participants (actual)

Study arms

Experimental
Test Subject
All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors
Device: Philips FAST SpO2 with Masimo Pulse Oximetry Sensors

Interventions

DevicePhilips FAST SpO2 with Masimo Pulse Oximetry Sensors
Noninvasive pulse oximeter

What researchers measure

Primary outcomes

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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour
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.
Time frame: 1 hour

Results

Posted Mar 11, 2026

Participant flow

Participant flow — Overall Study
Milestone	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors
Started	70
Participants who received rd set® adt	28
Participants who received rd set® adt cs	28
Participants who received rd set® yi	28
Participants who received rd set® dbi	28
Participants who received lncs® adtx	36
Participants who received rd set® tc-i	30
Participants who received rd set® dci	36
Completed	67
Not completed	3
Withdrew: Physician decision	2
Withdrew: Withdrawal by subject	1

Outcome measures

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)
% of oxygen saturated hemoglobin	Philips FAST SpO2 With Masimo Pulse Oximetry Sensor (RD SET® Adt)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt)	1.84

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)
% of oxygen saturated hemoglobin	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors (RD SET® Adt CS)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS)	1.9

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)
% of oxygen saturated hemoglobin	Philips FAST SpO₂ With Masimo Pulse Oximetry Sensors (RD SET® YI)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI)	2.01

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)
% of oxygen saturated hemoglobin	Philips FAST SpO₂ With Masimo Pulse Oximetry Sensors (RD SET® DBI)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI)	1.99

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)
% of oxygen saturated hemoglobin	Philips FAST SpO₂ With Masimo Pulse Oximetry Sensors (LNCS® Adtx)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx)	2.84

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)
% of oxygen saturated hemoglobin	Philips FAST SpO₂ With Masimo Pulse Oximetry Sensors (RD SET® TC-I)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I)	3.12

PrimaryOxygen 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.

Time frame:: 1 hour
Reported as:: Number · % of oxygen saturated hemoglobin

Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)
% of oxygen saturated hemoglobin	Philips FAST SpO₂ With Masimo Pulse Oximetry Sensors (RD SET® DCI)
Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI)	3.85

Adverse events

Collected over 1 hour. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test Subject	0/70 (0%)	0/70 (0%)	18/70 (25.7%)

Most frequent other events

Most frequent other events
Event	Test Subject
LightheadednessInjury, poisoning and procedural complications	6/70
Abnormal Laboratory FindingInvestigations	5/70
NauseaGastrointestinal disorders	4/70
TachycardiaCardiac disorders	1/70
NumbnessNervous system disorders	1/70
HypotensionVascular disorders	1/70

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors
<=18 years	0
Between 18 and 65 years	67
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors
Female	29
Male	38

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors
White	18
Hispanic	13
Asian or Pacific Islander	8
Native American	0
Black or African American	25
Other	1
Mutiracial	2

Region of Enrollment
Region of Enrollment(participants)	Philips FAST SpO2 With Masimo Pulse Oximetry Sensors
United States	67

Study locations

1 site

Masimo Corporation
Irvine, California 92618, United States

References and documents

Study documents

Protocol and statistical analysis plan · Oct 10, 2023

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06148623
Lead sponsor: Masimo Corporation
Responsible party: Sponsor
First posted: Nov 28, 2023
Start date: Nov 13, 2023
Primary completion: Jan 14, 2025
Completion: Jan 14, 2025
Results posted: Mar 11, 2026
Last update: Apr 2, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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