Pulse Oximetry_Performance During Severe Signal Interference - PCBA-1 (Printed Circuit Board Assembly)
This study has been completed.
Information provided by (Responsible Party):
First received: November 27, 2012
Last updated: December 5, 2013
Last verified: December 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|
|Official Title:||Controlled Acute Hypoxia Studies Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well-perfused Subjects With the Functional Monitoring PCBA-1|
Further study details as provided by Covidien:
Primary Outcome Measures:
- SpO2 Accuracy (percentage of blood oxygen saturation) [ Time Frame: Duration of subject visit- approx. 1.5 hours ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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