Philips FAST Evaluation

NCT ID: NCT06860230

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-07-11

Brief Summary

Evaluation of Philips FAST technology with Nellcor sensors

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

Conditions

Oxygen Saturation Measurement

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors

Intervention Type: DEVICE

Noninvasive pulse oximeter

Interventions

Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors

Noninvasive pulse oximeter

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Medical Systems

INDUSTRY

Sponsor Role: collaborator

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall M Clark, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medtronic Clinical Physiology Lab

Locations

Medtronic Clinical Physiology Lab

Denver, Colorado, United States

Countries

United States

Other Identifiers

MDT24049NELFST

Identifier Type: -

Identifier Source: org_study_id