NCT05683366CompletedNot Applicable
Philps FAST picoSAT Pulse Oximetry Desaturation Study
Philips Clinical & Medical Affairs Global1 site in 1 country72 target enrollmentStarted: December 13, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053
Study Overview
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.
Detailed Description
To validate SpO2 accuracy performance of various SpO2 sensors with the Philips FAST Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053
Time Frame: 13DEC2022-Q3 2023
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
SpO2 Validation Study - Philips FAST 2024Pulse OximetryNCT06484452Philips Clinical & Medical Affairs Global113
Completed
Not Applicable
Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin PigmentationHealthyNCT06148623Masimo Corporation70
Completed
Not Applicable
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion ConditionsHypoxiaNCT02475668Nonin Medical, Inc13
Completed
Not Applicable
Fingertip Pulse Oximeter Clinical TestSPO2NCT01605955Andon Health Co., Ltd10
Completed
Not Applicable
Controlled Desaturation Study for TipTraQ SpO2 Performance ValidationHypoxiaNCT06634693PranaQ Pte. Ltd.12