Mitigating Cephalad Fluid Shifts: A NSBRI Study

Saint John's Cancer Institute

Status: Completed

Conditions: Intracranial Pressure

Treatments: Device: Custom Thigh Cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT03097523

JWCI-16-0501

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18-89 years old
• Willing and able to provide informed consent
• 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
• KPS ≥ 70
• 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

• Less than 2 weeks since any prior surgery
• ICP > 20 mmHg that cannot be clinically stabilized
• 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)
• Existing cardiovascular disease, diabetes, syncope, ocular disease that, in the opinion of the investigator, may confound the study results
• 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
• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

Study Arm

Experimental group

Description:

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

Treatment:

Device: Custom Thigh Cuff