Status:
COMPLETED
Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Low Oxygen Saturation
Eligibility:
All Genders
Up to 21 years
Brief Summary
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 c...
Detailed Description
1.0 BACKGROUND A common method for assessing the respiratory status of hospitalized pediatric and neonatal patients is the use of pulse oximetry. This noninvasive device uses a light emitting diode (...
Eligibility Criteria
Inclusion
- Signed Informed Consent (If the patient is a minor, signed parental consent will be obtained.)
- Anticipated need for pulse oximetry monitoring
- Arterial line in place as indicated per patient's clinical management needs
- Availability to analyze arterial blood saturation by Co-Oximeter or Blood Gas Analyzer
Exclusion
- Inability to provide informed consent (or parental consent)
- Known allergies to adhesive materials
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00843401
Start Date
January 1 2009
End Date
April 1 2010
Last Update
February 2 2011
Active Locations (1)
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1
Childrens Research Institute
Washington D.C., District of Columbia, United States, 20010