Hypoxia Clinical Trial
Official title:
Polso SpO2 Accuracy Validation Study
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
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.
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