Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization

Not Recruiting

Trial ID: NCT00939224


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
Chandra Ramamoorthy

Professor of Anesthesiology, Perioperative and Pain Medicine (Pediatric), Emerita


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

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.


device: Model 7600 Regional Oximeter System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chandra Ramamoorthy