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

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Brief Title

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.

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.
    


Study Type

Interventional


Primary Outcome

The correct ventricular catheter position (on post op CT) after single ventricular puncture.

Secondary Outcome

 Number of catheter changes

Condition

Hydrocephalus

Intervention

Ultrasound guided ventricular drain insertion

Study Arms / Comparison Groups

 Ultrasound guided arm
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

17

Start Date

November 2013

Completion Date

May 2019

Primary Completion Date

May 2019

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jürgen Beck, MD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT01973764

Organization ID

073/13


Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne


Study Sponsor

Jürgen Beck, MD, Principal Investigator, Dep. of Neurosurgery, University Hospital Bern


Verification Date

August 2019