Philps FAST2022 picoSAT Pulse Oximetry Desaturation Study

NCT05683366 | Completed FDA Device

• 1 other identifier: MA_PM_FAST 2022_2022_11492
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SpO2 (Peripheral Oxygen Saturation) Measurement Validation

Keywords

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053

  13DEC2022-Q3 2023

Secondary Outcomes (1)

• Over 70-100% SpO2, an ARMS of ≤ 3% in non-motion conditions for the following SpO2 Sensors: 989803128591, 989803205881, 989803205891, 989803205911, 989803205831, 989803205381, MAXAI, MAXNI, OxySoftN, 4004, and 4052

  20DEC2022 - Q3 2023

Study Arms (1)

Single Group

No interventions, single group.

Device: No Intervention

Interventions

No Intervention DEVICE

There is no intervention in this study

Single Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population will include healthy non-smoking (or refrained from smoking for 2 days) competent adults, 18-50 yrs of age. It is planned that a sufficient number of participants will be screened to enroll in order to collect a minimum of 200 data points per sensor between 60 completed participants. Enrolled participants will be separated into 2 test groups of 30 completed participants. Each test group will consist of a minimum of 10 participants, with a min. of 3 males and 3 females, per each broad skin pigmentation category of light, medium, and dark.

You may qualify if:

• Subject must have the ability to understand and provide written informed consent
• Subject is 18 to 50 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who has not smoked within 2 days prior to the study

You may not qualify if:

• Participant is considered as being morbidly obese (defined as BMI \>39.5)
• Compromised circulation, injury, or physical malformation of fingers, wrist, 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 participants to participate if the condition is noted and would not affect the particular sites utilized.) Female participants that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential). Smoker Participants who have refrained will be screened for 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 with continued indications of health issues, emphysema, COPD, lung disease Participants with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review) hypertension: systolic \>140mmHg, Diastolic \>90mmHg on 3 consecutive readings (reviewed during health screen) have had cardiovascular surgery 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 vascular diseases of the limbs Self-reported health conditions as identified in the Health Assessment Form (self-reported) 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 / chemotherapy Self-reported dermatological conditions at application site severe dermatitis, hyperkeratosis (e.g., ichthyosis), nail fungus 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 severe contact allergies to standard adhesives, latex 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 from test digits. Dye injection within the past 48 hours Other known health condition, should be considered upon disclosure in health assessment form Dysfunctional hemoglobin levels

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Study Design

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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: December 13, 2022
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)