NCT00881829

Hypoxia Blood Validation in Multiple Pulse Oximeters

Accuracy Validation in Multiple SpO2 Systems

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Clinimark, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Hypoxia

Interventions

Type	Name	Description
DEVICE	Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature	Measurement of physiological parameters.

Timeline

• Start date: 2016-08-09
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2009-04-15
• Last updated: 2021-02-26

Locations

1 site across 1 country: United States