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

Nonin Medical, Inc3 sites in 1 country100 target enrollmentJuly 2009

ConditionsCardiovascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiovascular Disease
Sponsor: Nonin Medical, Inc
Enrollment: 100
Locations: 3
Primary Endpoint: The success of the validation and calibration will be assessed through the Arms statistic.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

August 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nonin Medical, Inc

Responsible Party

Sponsor

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;