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| Name | Class |
|---|---|
| National Space Biomedical Research Institute | OTHER |
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This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir) placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Experimental | Patients with intraventricular catheter meeting eligibility criteria will undergo the following procedures:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom Thigh Cuff | Device | The aim is to achieve positive and near normal forward arterial vascular blood flow to the lower extremities. Milder cuff pressures up to 65 mmHg will be used to limit venous return to the upper body. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer | Noninvasive and invasive ICP monitoring following standard of care procedures requiring access to ventricular catheter | 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santosh Kesari, MD, PhD | Saint John's Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute at Providence Saint John's Health Center | Santa Monica | California | 90404 | United States |
Data transfers or sharing is restricted to those JWCI study personnel identified on the site delegation log and/or per data use agreements. Data will be provided to the study sponsor.
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