Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Nonin Medical, Inc

Stanford Investigator(s):

Intervention(s):

  • Device: Model 7600 Regional Oximeter System

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.

Ages Eligible for Study

N/A - 12 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chandra Ramamoorthy
6507235728
Not Recruiting