Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury

Not yet recruitingOBSERVATIONAL
Enrollment

292

Participants

Timeline

Start Date

July 5, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2027

Conditions
Traumatic Brain InjuriesIntracranial Hypertension
Interventions
PROCEDURE

Ventriculostomy

Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is a common procedure performed in this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.

PROCEDURE

Ventriculostomy + Locking Device

Involves inserting a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF) and reduce intracranial pressure (ICP). This is an alternative procedure performed for this type of patient. It can be performed by a frontal approach, using a standard point 10cm from the nasion and 3cm lateral to the midline in the skull. A burr hole is performed and then the catheter is inserted in the frontal horn of the ventricular system. During the insertion, a locking device is attached and secured at the burr hole defect. Then the catheter is tunneled subcutaneously and connected to an external ventricular drain collection system that allows also ICP measurement.

Sponsors
All Listed Sponsors
lead

Meditech Foundation

OTHER