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NCT00881829 Clinical Trial

Hypoxia Blood Validation in Multiple Pulse Oximeters

Hypoxia Clinical Trial

Official title:
Accuracy Validation in Multiple SpO2 Systems

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00881829
Other study ID # PR 2016-192 Rev 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 9, 2016
Est. completion date December 21, 2021

Study information
Verified date February 2021
Source Clinimark, LLC
Contact Dena M Raley, BSBE
Phone 303-249-6010
Email DMRaley@Clinimark.com
Is FDA regulated No
Health authority
Study type Observational

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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - healthy individuals between the age of 18-50 years. Exclusion Criteria: - Clotting disorders, diabetes, currently taking psychotropic medications.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.

Locations
Country Name City State
United States Clinimark Laboratories Louisville Colorado

Sponsors (1)
Lead Sponsor Collaborator
Clinimark, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Completion of study by all subjects 5 years
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