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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort Phase 1 | Cardiac Catheterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model 7600 Regional Oximeter System | Device | Non-invasive regional oxygen saturation measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| The success of the validation and calibration will be assessed through the Arms statistic. | Single visit |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue (somatic) sensor readings will be described using the descriptive statistics. | Single Visit |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lori M Mitchell, RN, BSN | Nonin Medical, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305-5640 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22858270 | Derived | Kreeger RN, Ramamoorthy C, Nicolson SC, Ames WA, Hirsch R, Peng LF, Glatz AC, Hill KD, Hoffman J, Tomasson J, Kurth CD. Evaluation of pediatric near-infrared cerebral oximeter for cardiac disease. Ann Thorac Surg. 2012 Nov;94(5):1527-33. doi: 10.1016/j.athoracsur.2012.05.096. Epub 2012 Aug 2. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Chicago |
| Illinois |
| 60612 |
| United States |
| Cincinnati Children Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |