Philips FAST Evaluation

NCT06860230 | Completed

• 1 other identifier: MDT24049NELFST
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Philips FAST technology with Nellcor sensors

Conditions

Oxygen Saturation Measurement

Keywords

pulse oximetry; Hypoxia

Outcome Measures

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.

  2 - 3 hours

Study Arms (1)

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

Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors DEVICE

Noninvasive pulse oximeter

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Subject is considered as being morbidly obese (defined as BMI \>39.5)
• 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)
• 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
• Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure
• tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
• MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
• Subjects with known respiratory conditions such as:
• uncontrolled / severe asthma
• flu or influenza type infection
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• unresolved respiratory or lung surgery
• emphysema, COPD, lung disease
• recent COVID (last 2 months)
• Subjects with known heart or cardiovascular conditions such as:

Sponsors & Collaborators

• Medtronic - MITG: lead
• Philips Medical Systems: collaborator

Study Sites (1)

Medtronic Clinical Physiology Lab

Denver, Colorado, 80218, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall M Clark, M.D.

  Medtronic Clinical Physiology Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 11, 2025
• Primary Completion: April 11, 2025
• Study Completion: July 11, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-01

Locations

US (1)