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Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
Not Recruiting
Trial ID: NCT00939224
Purpose
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 catheterization.
Official Title
Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
Stanford Investigator(s)
Chandra Ramamoorthy
Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric), Emerita
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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.
Intervention(s):
device: Model 7600 Regional Oximeter System
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Chandra Ramamoorthy
6507235728