Hypoxia Blood Validation in Multiple Pulse Oximeters

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00881829

PR 2016-192 Rev 1

Ages 18-50
All Genders
Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.

This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

Eligibility Criteria

Inclusion

Inclusion Criteria:

healthy individuals between the age of 18-50 years.

Exclusion

Exclusion Criteria:

Clotting disorders, diabetes, currently taking psychotropic medications.

Study Design

August 09, 2016

December 21, 2021

Study Description

The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification

Connect with a study center

Clinimark Laboratories
Louisville, Colorado 80027
United States
Active - Recruiting

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