SpO2 Validation Study - Philips FAST 2024 (FAST 2024)

September 9, 2025 updated by: Philips Clinical & Medical Affairs Global
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Louisville, Colorado, United States, 80027
        • Element Materials Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Test Group 1
  • M1131A (989803205831)
  • M1191T (989803128591)
  • M1191BL (989803144381) for endpoint analysis
  • M1193A (989803205881)
Device: No Intervention
No Intervention
Test Group 2
  • M1194A (989803205891)
  • Alar (989803205381)
  • M1191BL (989803144381) as an internal reference only
Device: No Intervention
No Intervention
Test Group 3
  • EX-Alar on Nasal Ala (Experimental)
  • EX-Alar on Ear (Experimental)
  • M1191BL (989803144381) as an internal reference only
Device: No Intervention
No Intervention
Test Group 4
  • M1133A (989803205851)
  • EX-M1133A (Experimental)
  • M1196T (989803205911)
  • EX-M1196T (Experimental)
  • M1191BL (989803144381) as an internal reference only (optional)
Device: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
May-August 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-Disparate Bias
Time Frame: May-August 2024
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%.
May-August 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philips Clinical & Medical Affairs Global

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CC-300177-FAST 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study did NOT meet the ACT requirments and will not have results posted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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