Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors
The general purpose of this study is to evaluate the feasibility, accuracy and performance of the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry sensors over clinically relevant ranges of arterial saturations between 60-100%.
The study objectives are as follows:
- To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg.
- To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 60-80% in the following weight categories: 0-5kg; and, 5-40kg.
- To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and, 5-40kg.
|Low Oxygen Saturation|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors|
|Study Start Date:||January 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843401
|United States, District of Columbia|
|Childrens Research Institute|
|Washington, District of Columbia, United States, 20010|