Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nonin Medical, Inc
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
