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Accuracy of Continuous SpO2 Measurement in Adults — SPO2  

Healthy Clinical Trial

Official title:
SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01183338
Study type Observational
Source Sotera Wireless, Inc.
Contact
Status Withdrawn
Phase N/A
View Details
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