Mitigating Cephalad Fluid Shifts: A NSBRI Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Arm 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.
|
Outcome Measures
Primary Outcome Measures
- Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer [20 minutes]
Noninvasive and invasive ICP monitoring following standard of care procedures requiring access to ventricular catheter
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, 18-89 years old
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Willing and able to provide informed consent
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Patients who have an intraventricular catheter 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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KPS ≥ 70
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For patients on active anti-cancer (intra-thecal or IV) therapy, must be at least 2 weeks since last treatment; oral therapy is permitted
Exclusion Criteria:
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Less than 2 weeks since any prior surgery
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ICP > 20 mmHg that cannot be clinically stabilized
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Pregnant (Note: women of child-bearing potential must have a negative urine pregnancy test; women who are not of child-bearing potential are defined as: post-menopausal, age > 55 years with cessation of menses for 12 or more months; or less than 55 years with postmenopausal status confirmed by follicle-stimulating hormone in the post-menopausal range; or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
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Existing cardiovascular disease, diabetes, syncope, ocular disease that, in the opinion of the investigator, may confound the study results
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Uncontrolled neurological symptoms such as headache, nausea or vomiting that, in the opinion of the investigator, will limit the patient's ability to participate in the study
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Injury, trauma, venous thromboembolism, peripheral arterial disease or any condition that, in the opinion of the investigator, will prevent the subject from tolerating the application of a thigh cuff; history of treated DVT is permitted
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | John Wayne Cancer Institute at Providence Saint John's Health Center | Santa Monica | California | United States | 90404 |
Sponsors and Collaborators
- Saint John's Cancer Institute
- National Space Biomedical Research Institute
Investigators
- Principal Investigator: Santosh Kesari, MD, PhD, Saint John's Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JWCI-16-0501