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Completed

NCT Number: NCT02870179

Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinimark Laboratories

Louisville, Colorado, 80027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals between the age of 18-50

Exclusion criteria

  • Clotting disorders, diabetes, currently taking psychotropic medications

Treatment and study plan

Pulse Oximeter

Device

Measurement of physiological parameters

Other names: Blood Pressure, Respiratory Rate, Respiratory Gassess, Temperature

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oxitone Medical Ltd.

Industry

Collaborators

  • Clinimark, LLC

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 17, 2016
Registry last updated
Apr 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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