Hypoxia
Conditions
Keywords
Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determines the measurement accuracy of the physiological parameters
Brief summary
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
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.
Interventions
DEVICEPulse Oximeter
Measurement of physiological parameters
Sponsors
Clinimark, LLC
Oxitone Medical Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals between the age of 18-50
Exclusion criteria
* Clotting disorders, diabetes, currently taking psychotropic medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect SpO2 data for accuracy statistical analysis by 12 subjects | 2 months | Data is collected in a digital form for 4-6 SpO2 stable plateaus in a specified range from 100% to 70%. |
| Accuracy data analysis | 2 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Error plots | 2 months | SpO2 versus (SpO2-Ref SpO2) will be generated with linear regression fit, mean, and upper 95% and lower 95% limits of agreement. |
Countries
United States
Outcome results
None listed