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Hypoxia Blood Validation in Multiple Pulse Oximeters

Hypoxia Clinical Trial

Official title:
Accuracy Validation in Multiple SpO2 Systems

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00881829
Study type Observational
Source Clinimark, LLC
Contact Dena M Raley, BSBE
Phone 303-249-6010
Email DMRaley@Clinimark.com
Status Recruiting
Phase
Start date August 9, 2016
Completion date December 21, 2021
View Details
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