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NCT02870179 Clinical Trial

Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

Hypoxia Clinical Trial

Official title:
Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02870179
Other study ID # PR 2016-191
Secondary ID
Status Completed
Phase N/A
First received August 10, 2016
Last updated April 19, 2017
Start date August 2016
Est. completion date September 2016

Study information
Verified date April 2017
Source Oxitone Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy individuals between the age of 18-50

Exclusion Criteria:

- Clotting disorders, diabetes, currently taking psychotropic medications

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Pulse Oximeter
Measurement of physiological parameters

Locations
Country Name City State
United States Clinimark Laboratories Louisville Colorado

Sponsors (2)
Lead Sponsor Collaborator
Oxitone Medical Ltd. Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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