Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors
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|ClinicalTrials.gov Identifier: NCT00843401|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 2, 2011
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.
|Condition or disease|
|Low Oxygen Saturation|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors|
|Study Start Date :||January 2009|
|Primary Completion Date :||April 2010|
|Study Completion Date :||April 2010|
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): NCT00843401
|United States, District of Columbia|
|Childrens Research Institute|
|Washington, District of Columbia, United States, 20010|