Polso SpO2 Accuracy Validation Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxia
- Sponsor
- ChroniSense Medical Ltd.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- SpO2 percentage
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation
Detailed Description
The purpose of this study is to validate the SpO2 accuracy and performance of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. It is expected that the Accuracy Root Mean Square (Arms) performance of the Polso Monitoring System will meet a specification of 3.5% or less in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data. A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study. A minimum of 10 healthy adult subjects, ranging in pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61:2011 and by the FDA's Guidance for Pulse Oximeters. The subjects will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The study population will include 10-15 healthy non-smoking (or has refrained from smoking for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable distribution of males and females of any race with varying skin tones including at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection will occur over a 2-5 day period for this study population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •10-15 Adults with a minimum of 4 males and a minimum of 4 females, with the balance made up of either
- •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
- •Subject 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 subjects to participate if the condition is noted and would not affect the particular sites utilized.)
- •Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- •Smoker Subjects who have refrained will be screened for COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
- •Subjects with known respiratory conditions such as: (self-reported)
- •uncontrolled / severe asthma,
- •pneumonia / bronchitis,
- •shortness of breath / respiratory distress,
- •unresolved respiratory or lung surgery with continued indications of health issues ,
- •emphysema, COPD, lung disease
Outcomes
Primary Outcomes
SpO2 percentage
Time Frame: Through study completion, 1 month average
Percentage of SpO2 measured by the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. Data analysis will follow ISO80601-2-61, Annex EE and the FDA Guidance Document for Pulse Oximeters (March 4, 2013).