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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
Sponsor:
Collaborator:
Clinimark, LLC
Information provided by (Responsible Party):
Leon Eisen, PhD, Oxitone Medical Ltd.

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.


Condition or disease Intervention/treatment
Hypoxia Device: 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.


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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Healthy volunteer
Smoker or non-smoker
Device: Pulse Oximeter
Measurement of physiological parameters
Other Names:
  • Blood Pressure
  • Respiratory Rate
  • Respiratory Gassess
  • Temperature




Primary Outcome Measures :
  1. 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%.

  2. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents of the Denver metropolitan area
Criteria

Inclusion Criteria:

  • Healthy individuals between the age of 18-50

Exclusion Criteria:

  • Clotting disorders, diabetes, currently taking psychotropic medications

Information from the National Library of Medicine

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


Locations
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United States, Colorado
Clinimark Laboratories
Louisville, Colorado, United States, 80027
Sponsors and Collaborators
Oxitone Medical Ltd.
Clinimark, LLC
Investigators
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Principal Investigator: Leon Eisen, PhD Oxitone Medical Ltd.

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Responsible Party: Leon Eisen, PhD, Leon Eisen, CEO, Oxitone Medical Ltd.
ClinicalTrials.gov Identifier: NCT02870179     History of Changes
Other Study ID Numbers: PR 2016-191
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by Leon Eisen, PhD, Oxitone Medical Ltd.:
Pulse Oximetry
Temperature
Respiratory Rate
Respiratory Gases
This study determines the measurement accuracy of the physiological parameters
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms