Hypoxia Blood Validation in Multiple Pulse Oximeters

Clinimark

Status: Unknown

Conditions: Hypoxia

Treatments: Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature

Study type: Observational

Funder types: Other

Identifiers

NCT00881829

PR 2016-192 Rev 1

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Clotting disorders, diabetes, currently taking psychotropic medications.

Trial design

500 participants in 1 patient group

Healthy volunteer

Description:

Smoker or non-smoker

Treatment:

Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature