Trials / Withdrawn
WithdrawnNCT01183338
Accuracy of Continuous SpO2 Measurement in Adults
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
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (estimated)
- Sponsor
- Sotera Wireless, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Timeline
- First posted
- 2010-08-17
- Last updated
- 2011-06-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01183338. Inclusion in this directory is not an endorsement.