Accuracy of Continuous SpO2 Measurement in Adults
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2010 |
| End Date: | December 2010 |
Pivotal Clinical Evaluation of ViSiâ„¢ Mobile Monitoring System for the Continuous Measurement of SpO2
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational
device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human
subjects.
This study is a single-center blinded study that will enroll up to 15 adult subjects, male
or female, of any ethnic background.
SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous
measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse
oximeter, respectively. The paired measurements will be made in a well-controlled
environment under optimal laboratory conditions.
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