Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry
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|ClinicalTrials.gov Identifier: NCT02870179|
Recruitment Status : Completed
First Posted : August 17, 2016
Last Update Posted : April 20, 2017
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.
|Condition or disease||Intervention/treatment|
|Hypoxia||Device: Pulse Oximeter|
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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|Official Title:||Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Smoker or non-smoker
Device: Pulse Oximeter
Measurement of physiological parameters
- Collect SpO2 data for accuracy statistical analysis by 12 subjects [ Time Frame: 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 [ Time Frame: 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).
- Error plots [ Time Frame: 2 months ]SpO2 versus (SpO2-Ref SpO2) will be generated with linear regression fit, mean, and upper 95% and lower 95% limits of agreement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870179
|United States, Colorado|
|Louisville, Colorado, United States, 80027|
|Principal Investigator:||Leon Eisen, PhD||Oxitone Medical Ltd.|