Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors

Completed

Conditions studied: Low Oxygen Saturation

In brief

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: 1. To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg. 2. 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. 3. 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.

Key facts

Study ID

NCT00843401

Run by

Children's National Research Institute

People needed

100

Starts

2009-01-01

Expected to finish

2010-04-01

Last updated by the study team

2011-02-02

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Inability to provide informed consent (or parental consent)
• Known allergies to adhesive materials

Where it is running

• Childrens Research Institute — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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