Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

Completed

• Conditions: Hypoxia
• Interventions: Device: Pulse Oximeter

• Registration Number: NCT02870179
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-17
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Healthy individuals between the age of 18-50

Exclusion Criteria

• Clotting disorders, diabetes, currently taking psychotropic medications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	Pulse Oximeter	Smoker or non-smoker

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinimark Laboratories; 🇺🇸 Louisville, Colorado, United States