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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nonin Medical, Inc
ClinicalTrials.gov Identifier:
NCT00939224
First received: July 10, 2009
Last updated: August 23, 2011
Last verified: August 2011
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization

Resource links provided by NLM:


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 ]

Enrollment: 100
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Phase 1
Cardiac Catheterization
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305-5640
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Ohio
Cincinnati Children Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Nonin Medical, Inc
Investigators
Study Director: Lori M Mitchell, RN, BSN Nonin Medical, Inc
  More Information

No publications provided by Nonin Medical, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nonin Medical, Inc
ClinicalTrials.gov Identifier: NCT00939224     History of Changes
Other Study ID Numbers: QATP1542
Study First Received: July 10, 2009
Last Updated: August 23, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014