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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939224
• Other study ID #: QATP1542
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: August 23, 2011
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Device:
• Model 7600 Regional Oximeter System
Non-invasive regional oxygen saturation measurements

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children Hospital Medical Center	Cincinnati	Ohio
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Nonin Medical, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success of the validation and calibration will be assessed through the Arms statistic.		Single visit	No
Secondary	Tissue (somatic) sensor readings will be described using the descriptive statistics.		Single Visit	No