An interventional study of Custom Thigh Cuff in Intracranial Pressure, sponsored by Saint John's Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2017-08-16.
Sponsored by Saint John's Cancer Institute · Not applicable, Interventional, and Prevention
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.
Saint John's Cancer Institute is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with intraventricular catheter meeting eligibility criteria will undergo the following procedures: * Blood pressure, heart rate, electrocardiogram and Intracranial Pressure (ICP) monitoring after standard of care procedures are completed * Continuous ICP monitoring using a disposable pressure transducer (i.e., TruWaveTM) * Sequential placement in an upright, seated, supine 0°, and supine 15° head down tilt (HDT) positions for approximately 15 minutes for stabilization, followed by: Non-invasive ICP, intra-ocular pressure (IOP) assessment, femoral vascular ultrasound, jugular vascular ultrasound, and assessment of adverse events
Device: Custom Thigh Cuff
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.
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
Time frame: 20 minutes
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Saint John's Cancer Institute