Pulse OximetryFAST 2024NCT06484452
SpO2 Validation Study - Philips FAST 2024
An observational study of Pulse Oximetry, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 29 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The study population for this protocol will include a minimum of 96 to a maximum of 120 healthy, competent adult male and female participants of any race and ranging in pigmentation from light to dark. Participants will be non-smoking (or have refrained from smoking for 2 days) and between the ages of 18-50 years old.
Who may be able to join
- Participant must have the ability to understand and provide written informed consent
- Participant is adult between 18-50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days prior to the study.
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Participants with compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears, nose, forehead/skull, or other sensor sites which would limit the ability to test sites needed for the study. Tattoo (e.g. permanent, Henna) or artificial dyes (including spray tan, pigmented tanning lotion) in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized.)
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Participants with known respiratory conditions such as: (self-reported)
- uncontrolled / severe asthma,
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- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery,
- emphysema, COPD, lung disease,
- Recent COVID (last 2 months)
- Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen),
- have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA),
- chest pain (angina),
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen),
- previous heart attack,
- blocked artery,
- unexplained shortness of breath,
- congestive heart failure (CHF),
- history of stroke,
- transient ischemic attack,
- carotid artery disease,
- myocardial ischemia,
- myocardial infarction,
- cardiomyopathy,
- implantable active medical device such as pacemaker or automatic defibrillator
- Participants with self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent symptomatic head injury (within the last 2 months),
- Cancer requiring chemotherapy, radiation, or current treatment
- Participants with known clotting disorders (self-reported)
- history of bleeding disorders or personal history of prolonged bleeding from injury,
- history of blood clots,
- hemophilia,
- current use of blood thinner: prescription or daily use of aspirin,
- Sickle Cell Trait or Disease
- Participants with self-reported dermatological conditions at sensor application sites
- Severe dermatitis,
- Hyperkeratosis,
- Nail fungus
- Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Participants with severe allergies to iodine (only applicable if iodine is used)
- Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine),
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio <0.4)
- Unwillingness or inability to remove colored nail polish or artificial nails from test digits
- Participants with stretched or dilated piercings at the application site of ear sensors. (Applicable for test groups with M1194A and EX-Alar on ear only.)
- Participant received intravascular dye within the past 48 hours (e.g. Indocyanine green, methylene blue, dyes used in cardiac output monitoring)
- Surgical hardware in pathway of Device Under Test
- Other known health condition, should be considered upon disclosure in health assessment form
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
Read the detailed description
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips FAST Pulse Oximetry technology during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
- Conditions
- Pulse Oximetry
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDevice
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 | * M1131A (989803205831)
* M1191T (989803128591)
* M1191BL (989803144381) for endpoint analysis
* M1193A (989803205881) Receives: Device: No Intervention | |
| Test Group 2 | * M1194A (989803205891)
* Alar (989803205381)
* M1191BL (989803144381) as an internal reference only Receives: Device: No Intervention | |
| Test Group 3 | * EX-Alar on Nasal Ala (Experimental)
* EX-Alar on Ear (Experimental)
* M1191BL (989803144381) as an internal reference only Receives: Device: No Intervention | |
| Test Group 4 | * M1133A (989803205851)
* EX-M1133A (Experimental)
* M1196T (989803205911)
* EX-M1196T (Experimental)
* M1191BL (989803144381) as an internal reference only (optional) Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy
Accuracy expressed in ARMS of SpO2 measurements obtained from the SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2, in comparision to SaO2 as ground truth.
Measured: May-August 2024
Secondary outcomes (1)
Non-Disparate Bias
Non-disparate bias and differential mean bias of the SpO2 sensors under test in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% < SaO2 ≤ 100%.
Measured: May-August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start6 May 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484452
- Sponsor's protocol ID
- CC-300177-FAST 2024
- Acronym
- FAST 2024
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study did NOT meet the ACT requirments and will not have results posted.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Validation Study - Philips FAST 2024
- ClinicalTrials.gov ID
- NCT06484452
- Acronym / sponsor ID
- FAST 2024 / CC-300177-FAST 2024
- Conditions
- Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
Detailed description
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips FAST Pulse Oximetry technology during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 | – | Device: No Intervention* M1131A (989803205831) * M1191T (989803128591) * M1191BL (989803144381) for endpoint analysis * M1193A (989803205881) |
| Test Group 2 | – | Device: No Intervention* M1194A (989803205891) * Alar (989803205381) * M1191BL (989803144381) as an internal reference only |
| Test Group 3 | – | Device: No Intervention* EX-Alar on Nasal Ala (Experimental) * EX-Alar on Ear (Experimental) * M1191BL (989803144381) as an internal reference only |
| Test Group 4 | – | Device: No Intervention* M1133A (989803205851) * EX-M1133A (Experimental) * M1196T (989803205911) * EX-M1196T (Experimental) * M1191BL (989803144381) as an internal reference only (optional) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population for this protocol will include a minimum of 96 to a maximum of 120 healthy, competent adult male and female participants of any race and ranging in pigmentation from light to dark. Participants will be non-smoking (or have refrained from smoking for 2 days) and between the ages of 18-50 years old.
Key inclusion criteria (4 listed)
- Participant must have the ability to understand and provide written informed consent
- Participant is adult between 18-50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days prior to the study.
Key exclusion criteria (57 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Participants with compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears, nose, forehead/skull, or other sensor sites which would limit the ability to test sites needed for the study. Tattoo (e.g. permanent, Henna) or artificial dyes (including spray tan, pigmented tanning lotion) in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized.)
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Participants with known respiratory conditions such as: (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Device | Test Group 1, Test Group 2, Test Group 3, Test Group 4 |
Primary outcome
SpO2 Accuracy
Time frame: May-August 2024
Accuracy expressed in ARMS of SpO2 measurements obtained from the SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2, in comparision to SaO2 as ground truth.
1 secondary outcome
Non-Disparate Bias
Time frame: May-August 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Study did NOT meet the ACT requirments and will not have results posted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulse Oximetry, run by Philips Clinical & Medical Affairs Global 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 4 inclusion and 57 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 16 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SpO2 Accuracy (time frame: May-August 2024). 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 16 Sep 2025.