Accuracy of Continuous SpO2 Measurement in Adults (SPO2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01183338|
Recruitment Status : Withdrawn
First Posted : August 17, 2010
Last Update Posted : June 22, 2011
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||15 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183338
|United States, Colorado|
|Clinimark Desaturation Laboratory|
|Louisville, Colorado, United States, 80027|
|Principal Investigator:||Philip S. Clifford, PhD||VA Office of Research and Development|