Hypoxia
Conditions
Keywords
Pulse Oximetry, Temperature, Respiratory Rate, Respiratory Gases, This study determine the measurement accuracy of the physiological parameters
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
Interventions
DEVICEPulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
Measurement of physiological parameters.
Sponsors
Clinimark, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy individuals between the age of 18-50 years.
Exclusion criteria
* Clotting disorders, diabetes, currently taking psychotropic medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion of study by all subjects | 5 years |
Countries
United States
Contacts
Primary ContactDena M Raley, BSBE
Backup ContactPaul B Batchelder, RRT
Outcome results
None listed