Status:
COMPLETED
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
Lead Sponsor:
Nonin Medical, Inc
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
Up to 12 years
Brief Summary
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac...
Eligibility Criteria
Inclusion
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is between 0 days and 12 years of age;
- Is less than 40 kg;
- The subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
- The scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
- The subject is American Society Anesthesiologist (ASA) status 1 through 4; and
- The subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.
Exclusion
- Is greater than twelve (12) years of age;
- Has pre-existing allergies to adhesive tapes or adhesives on neonatal ECG pads;
- Has pre-existing skin condition at the site where the Nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
- Has craniofacial disease preventing application of the sensor to the forehead;
- Has sickle cell anemia or other hemoglobinopathy;
- Has disease of the cerebrovasculature including the jugular or carotid vessels;
- Was previously on ECMO involving the carotid or jugular vessels that could have resulted in disease or ligation;
- Is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
- Has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
- Has an emergency, life-threatening condition (American Society of Anesthesiologists Physical status 5 or 6) impacting the ability to obtain informed consent;
- Or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00939224
Start Date
July 1 2009
End Date
August 1 2011
Last Update
August 25 2011
Active Locations (3)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305-5640
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Cincinnati Children Hospital Medical Center
Cincinnati, Ohio, United States, 45229