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Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric | Subjects meeting inclusion criteria weighing between 4 and 40 kg |
| |
| Infant | Subjects meeting inclusion criteria weighing under 40 kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the root mean square | root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling | At the point of blood sampling during cardiac catheterization procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
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| Name | Affiliation | Role |
|---|---|---|
| Ami R Stuart, PhD | Principal Clinical Research Specialist | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States | ||
| Washington University St. Louis |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| INVOS monitoring | Device | During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry. |
|
| St Louis |
| Missouri |
| 63110 |
| United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Children's | Cleveland | Ohio | 44195 | United States |
| Seattle Children's | Seattle | Washington | 98105 | United States |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |