Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System

Study Overview
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Brief Summary
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Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure.Therefore a safe and fast surgical procedure is needed. Currently the landmark-based placement of intraventricular catheters is the gold standard. However it is known that more than 60% of the catheters are not accurately placed in accordance with landmark-based procedures. When the catheter is not placed accurately multiple punctures may be required. In this study, the investigators aim to investigate prospectively whether ultrasound guidance leads to a lower number of incorrect catheter placements, and whether this guidance consequently decreases the number of punctures.

Detailed Description
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Background Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed. Currently the landmark-based placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing landmark-based procedures. When the catheter is not placed accurately multiple punctures may has to be done. Puncture of the ventricular system is one of the most frequently performed neurosurgical interventions. This procedure is commonly performed in order to treat and/or measure pathologically elevated intracranial pressure. Therefore a safe and fast surgical procedure is needed.Currently the landmark-based placement of intraventricular catheters is the gold standard. Nonetheless it is known that more than 60% of the catheters are not placed accurately performing landmark-based procedures. When the catheter is not placed accurately multiple punctures may be required. Incorrectly placed intraventricular catheters may lead to undesirable side effects like catheter dysfunction,in which case a correction of the catheter position or a even a new puncture will be required. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain injuries. In this study, the investigators will prospectively investigate whether ultrasound guidance increases the number of well-placed ventricular catheters and reduces the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the lateral ventricle (ipsilateral to the burrhole) anterior of the foramen of Monro. Catheter tip position will be assessed by cranial computer tomography after the operation. The CT scans will be evaluated by an independent expert rater, blinded for the procedure type. These incorrectly placed intraventricular catheters may lead to undesirable side effects, like catheter dysfunction wherefore a correction of the catheter position or a even a new puncture has to be done. These corrections increase the risk of intracerebral hemorrhages, infections or secondary brain damages. In this study, the investigators will prospectively investigate if ultrasound guidance may raise the number of well placed ventricular catheters and may reduce the number of undesirable side effects. In this study the correct catheter position is defined when the catheter tip is located in the ipsilateral lateral ventricle (to the burrhole) anterior of the foramen of monroi and will be assessed by cranial computer tomography after operation. The CT Scans will be evaluated by an independent expert rater, blinded for the procedure type. Objective Aim of the study is to investigate whether ultrasound guidance of ventricular catheter placement leads to a lower number of incorrectly placed catheters and lower number of punctures compared to the landmark-based procedure. Methods This study is a prospective randomized controlled clinical trial. A total of 90 patients will be included in the study and randomized in two groups with 45 patients each (ultrasound-guided group and landmark-based group). The position of the ventricular catheter will be assessed using cranial computer tomography (CCT). The CT Scans will be evaluated by two independent expert raters, blinded for the procedure type.

Official Title
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Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.

Conditions
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Hydrocephalus, Intracranial Hypertension

Intervention / Treatment
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* Procedure: Ultrasound guided ventricular drain insertion
* Procedure: landmark-based ventricular drain insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 years Intraventricular catheter insertion or/and intraventricular pressure measurement indicated Written informed consent Exclusion Criteria Age < 18 years previous ventricular punction < 4 weeks bedside puncture indicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ultrasound guided arm<br> | Procedure: Ultrasound guided ventricular drain insertion<br>* Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.<br>|
| Other: Landmark-based arm<br> | Procedure: landmark-based ventricular drain insertion<br>* Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The correct ventricular catheter position (on post op CT) after single ventricular puncture. |  | 48 h after initial operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of catheter changes |  | at hospital discharge, expected to be after 10 days | 
| Number of infections |  | at hospital discharge, expected to be after 10 days | 
| Number of days in clinic |  | at hospital discharge, expected to be after 10 days | 
| Number of ventricular punctures |  | at the end of the operation, expected to be after 1 hour | 
| Number of patients with intracerebral hemorrhage |  | 24 h after initial operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative ultrasound, Ventricular System, Ventricular catheter, Ventriculostomy, Hydrocephalus, Excessive accumulation of cerebrospinal fluids within the cranium. Often associated with dilatation of cerebral ventricles, Intracranial Hypertension, increased pressure within the cranial vault. This may result from several conditions, including hydrocephalus, brain edema., Puncture