Hypoxia Blood Validation in Multiple Pulse Oximeters
- Conditions
- Hypoxia
- Interventions
- Device: Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature
- Registration Number
- NCT00881829
- Lead Sponsor
- Clinimark, LLC
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- healthy individuals between the age of 18-50 years.
- Clotting disorders, diabetes, currently taking psychotropic medications.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy volunteer Pulse Oximeter, Blood Pressure, Respiratory Rate, Respiratory Gasses, Temperature Smoker or non-smoker
- Primary Outcome Measures
Name Time Method Completion of study by all subjects 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinimark Laboratories
🇺🇸Louisville, Colorado, United States