Ultrasound (US) Guided External Ventricular Catheter Placement
ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Decision made to perform the procedure by the primary consultant
Age 18 or older
Neuro ICU stay
Newly diagnosed hydrocephalus
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Catheter Placement with Solopass System
DeviceThis 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Catheter placement with Solopass systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Average number of passes needed to place the catheter in each subject.
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.
Time frame
0 minutesSecondary outcomes
1
Post procedure imaging accuracy of the placement of the EVD will be performed by reviewing post procedure imaging using the Kakarla scoring system
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
Time frame
up to 7 daysOther outcomes
1
Length of time of the procedure
Number of minutes necessary to complete the procedure placement of the catheter
Time frame
Up to three hours2
Number of revision
Quantity of revisions due to the catheter malfunction
Time frame
up to 7 days3
Number of subjects with Cerebrospinal fluid (CSF) infection
CSF will be collected as part of standard of care after the procedure and tested for infection.
Time frame
up to 7 days4
Number of subjects with Superficial surgical site infection (SSI)
(The CDC defines SSI as deep and superficial. A superficial incisional SSI is an infection in the area of the skin where the incision was made. A deep incisional SSI occurs beneath the incision area in the muscle and the tissues surrounding the muscles. Signs to be monitored daily and put in a checklist will include redness, pain, unexplained fever source, pain, warmth, pus or swelling.)
Time frame
up to 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov