Hydrocephalus
Conditions
Brief summary
To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
Interventions
DEVICECatheter Placement with Solopass System
This device is used as a guidance for placing a brain catheter to target the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Decision made to perform the procedure by the primary consultant * Age 18 or older * Neuro ICU stay * Newly diagnosed hydrocephalus * Has a recent CT within the past 24 hrs * Normal platelets and coagulation profile * No active infection or currently on antibiotics * The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging
Exclusion criteria
* Age \<18 * Not in Neuro ICU setting * Previous placement of a ventricular catheter * More than 50 percent of the fluid compartment is filled with blood by CT scan * Time to include in the trial prohibited by clinical personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average number of passes needed to place the catheter in each subject. | 0 minutes | Measured by the number of passes needed to place the catheter. If the first attempt fails, another US sweep will be performed, and another attempt will be performed. If that fails, then the procedure will be aborted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system | up to 7 days | Grade 1 means optimal placement in the ipsilateral frontal horn or third ventricle; Grade 2 means a functional placement in the contralateral lateral ventricle or no eloquent cortex; and Grade 3 means suboptimal placement in the eloquent cortex or nontarget cerebrospinal fluid space, with or without functional drainage |
Countries
United States
Contacts
CONTACTSara Craig, MNR, BS
PRINCIPAL_INVESTIGATORJ C Zacko, MD
Milton S. Hershey Medical Center
Outcome results
None listed