Pulse Oximetry- Performance During Severe Signal Interference
This study has been completed.
Information provided by (Responsible Party):
First received: October 31, 2012
Last updated: February 12, 2013
Last verified: February 2013
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse subject population during severe signal interference over a specified saturation range.
|Study Design:||Time Perspective: Prospective|
Further study details as provided by Covidien:
Primary Outcome Measures:
- SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: 1.5 hours per subject ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Contacts and Locations