Clinical trial NCT01973764: Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
Official title: Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hydrocephalus
Intracranial Hypertension
Keywords: Intraoperative ultrasound
Ventricular System
Puncture
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.
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The correct ventricular catheter position (on post op CT) after single ventricular puncture.
timeFrame: 48 h after initial operation
Secondary outcomes:
measure: Number of catheter changes
timeFrame: at hospital discharge, expected to be after 10 days
measure: Number of infections
timeFrame: at hospital discharge, expected to be after 10 days
measure: Number of days in clinic
timeFrame: at hospital discharge, expected to be after 10 days
measure: Number of ventricular punctures
timeFrame: "at the end of the operation, expected to be after 1 hour"
measure: Number of patients with intracerebral hemorrhage
timeFrame: 24 h after initial operation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Neurosurgery, Bern University Hospital
Study officials:
affiliation: Dep. of Neurosurgery, University Hospital Bern
name: Jürgen Beck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Neurosurgery, University Hospital
name: Andreas Raabe, MD
role: STUDY_DIRECTOR
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citation: Maniker AH, Vaynman AY, Karimi RJ, Sabit AO, Holland B. Hemorrhagic complications of external ventricular drainage. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS419-24; discussion ONS424-5. doi: 10.1227/01.NEU.0000222817.99752.E6.