Ultrasound (US) Guided External Ventricular Catheter Placement

Hydrocephalus Clinical Trial

Official title:

Ultrasound (US) Guided External Ventricular Catheter Placement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06253858
• Other study ID #: STUDY00022095
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: April 2024
• Source: Milton S. Hershey Medical Center
• Contact: Micaiah Grien
• Phone: 717-531-0003
• Email: mgrien[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Catheter 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of time of the procedure	Number of minutes necessary to complete the procedure placement of the catheter	Up to three hours
Other	Number of revision	Quantity of revisions due to the catheter malfunction	up to 7 days
Other	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.	up to 7 days
Other	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.)	up to 7 days
Other	Longevity of the device function	Number of days until a subsequent catheter is placed	up to 7 days
Primary	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.	0 minutes
Secondary	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	up to 7 days