Status:
TERMINATED
Validation of Brain Oxygenation Monitor on Pediatric Patients
Lead Sponsor:
Duke University
Collaborating Sponsors:
CAS Medical Systems, Inc.
Conditions:
Cardiac Catheterization
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a...
Detailed Description
NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the finger tip. The se...
Eligibility Criteria
Inclusion
- ≤ 18 years old
- ≥ 2.5 kg and ≤ 40 kg weight
- Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory
Exclusion
- Known structural neurologic or craniofacial disease
- Arterial catheter placement not part of planned catheterization procedure
- Anemia (hemoglobin \< 10 g/dl)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00849940
Start Date
February 1 2009
End Date
November 1 2014
Last Update
February 9 2017
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710