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

Study Overview
=================
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.

Official Title
-----------------
Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Device: Model 7600 Regional Oximeter System


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort Phase 1<br>Cardiac Catheterization | Device: Model 7600 Regional Oximeter System<br>* Non-invasive regional oxygen saturation measurements<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success of the validation and calibration will be assessed through the Arms statistic. |  | Single visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue (somatic) sensor readings will be described using the descriptive statistics. |  | Single Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near-infrared spectroscopy (NIRS), Regional oxygen saturation, Pediatrics, Cardiac catheterization, Congenital heart disease