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CompletedNCT06860230NELFSTUpdated Jul 25, 2025

Philips FAST Evaluation

An observational study in Oxygen Saturation Measurement, sponsored by Medtronic - MITG. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Medtronic - MITG · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Evaluation of Philips FAST technology with Nellcor sensors

Read the detailed description

Evaluate saturation accuracy claims for the Philips picoSAT X SpO2 board with FAST algorithm, paired with Nellcor™ sensors in a diverse subject population, over a specified saturation range

02

Conditions studied

  • Oxygen Saturation Measurement

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Keywords

  • pulse oximetry
  • Hypoxia
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 27 is below the median of 67 across 335 observational studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy subjects ≥ 18 and \< 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.

Inclusion criteria

  1. Subjects ≥ 18 and \< 51 years of age
  2. Subject is willing and able to comply with study procedures and duration
  3. Subject is willing to sign an informed consent
  4. Subject weighs >40kg
  5. Subject is a non-smoker or has not smoked within 36 hours prior to the study
  6. Cleared same day health assessment form and health screening

Exclusion criteria

Exclusion Criteria:

  1. Subject is considered as being morbidly obese (defined as BMI >39.5)
  2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
  3. Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
  4. Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
  5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
  6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
  7. Subjects with known respiratory conditions such as:

    1. uncontrolled / severe asthma
    2. flu or influenza type infection
    3. pneumonia / bronchitis
    4. shortness of breath / respiratory distress
    5. unresolved respiratory or lung surgery
    6. emphysema, COPD, lung disease
    7. recent COVID (last 2 months)
  8. Subjects with known heart or cardiovascular conditions such as:

    1. hypertension: systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings
    2. previous cardiovascular surgery
    3. chest pain (angina)
    4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
    5. previous heart attack
    6. blocked artery
    7. unexplained shortness of breath
    8. congestive heart failure (CHF)
    9. history of stroke
    10. transient ischemic attack
    11. carotid artery disease
    12. myocardial ischemia
    13. myocardial infarction
    14. cardiomyopathy
    15. implantable active medical device such as pacemaker or automatic defibrillator
  9. Self-reported health conditions as identified in the Health Assessment Form

    1. diabetes
    2. uncontrolled thyroid disease
    3. kidney disease / chronic renal impairment
    4. history of seizures (except childhood febrile seizures)
    5. epilepsy
    6. history of unexplained syncope
    7. recent history of frequent migraine headaches
    8. recent symptomatic head injury, within the last 2 months
    9. cancer requiring chemotherapy, radiation, or current treatment
    10. subjects with known clotting disorders
    11. history of bleeding disorders or personal history of prolonged bleeding from injury
    12. history of blood clots
    13. hemophilia
    14. sickle cell trait or disease
    15. current use of blood thinner: prescription or daily use of aspirin
    16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
    17. participants with severe allergy to iodine (only applicable if iodine is used)
    18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
    19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
    20. history of clinically significant complications from previous arterial cannulation
    21. Failure of Allen's test
    22. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
    23. other known health condition, upon disclosure in Health Assessment form at PI's discretion
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Volunteers

    All subjects who meet the inclusion criteria are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors

    Device: Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors

Interventions

  • DevicePhilips FAST SpO2 with Nellcor Pulse Oximetry Sensors

    Noninvasive pulse oximeter

06

What researchers measure

Primary outcomes

  1. Evaluation of Saturation Accuracy

    Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.

    Time frame: 2 - 3 hours

07

Study locations

1 site
  • Medtronic Clinical Physiology Lab
    Denver, Colorado 80218, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06860230
Lead sponsor
Medtronic - MITG
Collaborators
Philips Medical Systems
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Mar 11, 2025
Primary completion
Apr 11, 2025
Completion
Jul 11, 2025
Last update
Jul 25, 2025

Study contacts

Randall M Clark, M.D.
principal investigator · Medtronic Clinical Physiology Lab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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