Louisville, Colorado 80027

  • Hypoxia

Purpose:

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.


Study summary:

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


Criteria:

Inclusion Criteria: - healthy individuals between the age of 18-50 years. Exclusion Criteria: - Clotting disorders, diabetes, currently taking psychotropic medications.


NCT ID:

NCT00881829


Primary Contact:

Principal Investigator
David Ransom, MD
Avista Adventist Hospital

Dena M Raley, BSBE
Phone: 303-249-6010
Email: DMRaley@Clinimark.com


Backup Contact:

Email: PBatchelder@Clinimark.com
Paul B Batchelder, RRT
Phone: 303-717-4820


Location Contact:

Louisville, Colorado 80027
United States

Paul B Batchelder, RRT
Phone: 303-717-4820
Email: PBatchelder@Clinimark.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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