Pulse oximeter accuracy under the microscope: does skin color matter?
NCT ID NCT06148623
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested the accuracy of Philips FAST SpO2 pulse oximeters using Masimo sensors in 70 healthy adults with varying skin pigmentation. Researchers compared the device's oxygen readings to a gold-standard blood test to see if skin tone affects performance. The goal is to ensure these monitors work reliably for everyone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Philips FAST SpO2 with Masimo Pulse Oximetry Sensors (device)
- What this could lead to
- If successful, this could help ensure pulse oximeters work accurately for people of all skin tones, improving patient safety.
- What could go wrong
- This is a small, completed device validation study in healthy volunteers, not a treatment trial. Results may not apply to sick patients or real-world settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
70 people
The number who actually took part.
- Started
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Nov 2023
- Finished
-
Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Masimo Corporation
Irvine, California, 92618, United States
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