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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939224
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : August 25, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiovascular Disease Device: Model 7600 Regional Oximeter System

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Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort Intervention/treatment
Cohort Phase 1
Cardiac Catheterization
Device: Model 7600 Regional Oximeter System
Non-invasive regional oxygen saturation measurements

Primary Outcome Measures :
  1. The success of the validation and calibration will be assessed through the Arms statistic. [ Time Frame: Single visit ]

Secondary Outcome Measures :
  1. Tissue (somatic) sensor readings will be described using the descriptive statistics. [ Time Frame: Single Visit ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939224

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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
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Study Director: Lori M Mitchell, RN, BSN Nonin Medical, Inc
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nonin Medical, Inc Identifier: NCT00939224    
Other Study ID Numbers: QATP1542
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: August 25, 2011
Last Verified: August 2011
Keywords provided by Nonin Medical, Inc:
Near-infrared spectroscopy (NIRS)
Regional oxygen saturation
Cardiac catheterization
Congenital heart disease
Additional relevant MeSH terms:
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Cardiovascular Diseases