Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
Trial ID or NCT#
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.
Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
- - 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.
- - 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.
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