NCT03097523

Mitigating Cephalad Fluid Shifts: A NSBRI Study

Validation of a Cephalad Fluid Shift Countermeasure: Selection of Optimal Thigh Cuff Design Followed by Intracranial Pressure (ICP) Measurements During Extended Thigh Cuff Application

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Saint John's Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Pressure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2017-03-31
• Last updated: 2017-08-16

Locations

1 site across 1 country: United States