Hypoxia Blood Validation in Multiple Pulse Oximeters

• Conditions: Hypoxia

• Registration Number: NCT00881829
• Lead Sponsor: Clinimark, LLC

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Study Start: 2016-08-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• healthy individuals between the age of 18-50 years.

Exclusion Criteria

• Clotting disorders, diabetes, currently taking psychotropic medications.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion of study by all subjects	5 years

Trial Locations

Locations (1)

Clinimark Laboratories; 🇺🇸 Louisville, Colorado, United States