In Vivo Pulse Oximeter Validation Study
- Conditions
- Hypoxia
- Registration Number
- NCT05873335
- Lead Sponsor
- Gabi SmartCare
- Brief Summary
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device
A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Healthy adult
- Normal hemoglobin levels (Hemoglobin > 10 g/dL)
- Systemic illness
- Obesity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Measure of Accuracy (ARMS [%]) 1 hour Arms, given in percentage or rms error, is the calculation of root mean square between SpO2 values from the subject device and the SaO2 from the Hemoximeter. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurmeent to a "rms error". It indicates how far (accurate) the provided value is from the reference used.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hypoxia Research Laboratory
🇺🇸San Francisco, California, United States