Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

Study Overview
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Brief Summary
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The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.

Detailed Description
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The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study. A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, 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.

Official Title
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Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

Conditions
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Hypoxia

Intervention / Treatment
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* Device: Pulse Oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals between the age of 18-50 Exclusion Criteria: Clotting disorders, diabetes, currently taking psychotropic medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteer<br>Smoker or non-smoker | Device: Pulse Oximeter<br>* Measurement of physiological parameters<br>* Other names: Temperature;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect SpO2 data for accuracy statistical analysis by 12 subjects | Data is collected in a digital form for 4-6 SpO2 stable plateaus in a specified range from 100% to 70%. | 2 months | 
| Accuracy data analysis | Bland-Altman graphical plots. An Accuracy Root Mean Square (ARMS) calculation is used as a means to define the SpO2 accuracy. Data analysis will follow ISO80601-2-61, Annex EE and the FDA Guidance Document for Pulse Oximeters (Martch 4, 2013). | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Error plots | SpO2 versus (SpO2-Ref SpO2) will be generated with linear regression fit, mean, and upper 95% and lower 95% limits of agreement. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determines the measurement accuracy of the physiological parameters