Cardiovascular Disease
Conditions
Keywords
Near-infrared spectroscopy (NIRS), Regional oxygen saturation, Pediatrics, Cardiac catheterization, Congenital heart disease
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 catheterization.
Interventions
DEVICEModel 7600 Regional Oximeter System
Non-invasive regional oxygen saturation measurements
Sponsors
Nonin Medical, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success of the validation and calibration will be assessed through the Arms statistic. | Single visit |
Secondary
| Measure | Time frame |
|---|---|
| Tissue (somatic) sensor readings will be described using the descriptive statistics. | Single Visit |
Countries
United States
Outcome results
None listed