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

Completed

• Conditions: Cardiovascular Disease
• Interventions: Device: Model 7600 Regional Oximeter System

• Registration Number: NCT00939224
• Lead Sponsor: Nonin Medical, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-14
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-23
• Last Update Posted: 2011-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort Phase 1	Model 7600 Regional Oximeter System	Cardiac Catheterization

Primary Outcome Measures

Name	Time	Method
The success of the validation and calibration will be assessed through the Arms statistic.	Single visit

Secondary Outcome Measures

Name	Time	Method
Tissue (somatic) sensor readings will be described using the descriptive statistics.	Single Visit

Trial Locations

Locations (3)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Cincinnati Children Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States