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Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
This study is currently recruiting participants.
Verified by Nonin Medical, Inc, August 2009
First Received: July 10, 2009   Last Updated: August 17, 2009   History of Changes
Sponsored by: Nonin Medical, Inc
Information provided by: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT00939224
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Device: Model 7600 Regional Oximeter System

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization

Further study details as provided by Nonin Medical, Inc:

Primary Outcome Measures:
  • The success of the validation and calibration will be assessed through the Arms statistic. [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tissue (somatic) sensor readings will be described using the descriptive statistics. [ Time Frame: Single Visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: July 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Phase 1
Cardiac Catherization
Device: Model 7600 Regional Oximeter System
Non-invasive regional oxygen saturation measurements

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with cardiovascular disease (acquired or congenital; cyanotic or acyanotic; unrepaired, palliated or fully repaired) requiring cardiac catheterization to diagnose or treat the disease will be eligible for study.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939224

Contacts
Contact: Lori M Roth, RN, BSN 763-533-3093 lorir@nonin.com

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305-5640
Contact: Chandra Ramamoorthy, MD     650-724-7093     chandrar@stanford.edu    
Principal Investigator: Chandra Ramamoorthy, MD            
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Joan Hoffman, MD     312-972-9557     joan.hoffman@me.com]    
Principal Investigator: Joan Hoffman, MD            
United States, Ohio
Cincinnati Children Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jon Tomasson, MD     513-636-4408     Jon.Tomasson@cchmc.org    
Principal Investigator: Jon Tomasson, MD            
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
Study Director: Lori M Roth, RN, BSN Nonin Medical, Inc
  More Information

No publications provided

Responsible Party: Nonin medical, Inc ( Lori M Roth RN, BSN )
Study ID Numbers: QATP1542
Study First Received: July 10, 2009
Last Updated: August 17, 2009
ClinicalTrials.gov Identifier: NCT00939224     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Nonin Medical, Inc:
Near-infrared spectroscopy (NIRS)
Regional oxygen saturation
Pediatrics
Cardiac catherization
Congenital heart disease

Study placed in the following topic categories:
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 11, 2009