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Sponsored by: |
Nonin Medical, Inc |
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Information provided by: | Nonin Medical, Inc |
ClinicalTrials.gov Identifier: | NCT00939224 |
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 |
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
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Device: Model 7600 Regional Oximeter System
Non-invasive regional oxygen saturation measurements
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Ages Eligible for Study: | up to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Contact: Lori M Roth, RN, BSN | 763-533-3093 | lorir@nonin.com |
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 |
Study Director: | Lori M Roth, RN, BSN | Nonin Medical, Inc |
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 |
Near-infrared spectroscopy (NIRS) Regional oxygen saturation Pediatrics Cardiac catherization Congenital heart disease |
Heart Diseases |
Cardiovascular Diseases |