Trial record 19 of 38 for:    Open Studies | "Hydrocephalus"

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

This study is not yet open for participant recruitment.
Verified October 2013 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01973764
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Hydrocephalus
Intracranial Hypertension
Procedure: Ultrasound guided ventricular drain insertion
Procedure: landmark-based ventricular drain insertion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraventricular Drain Insertion:Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System. A Prospective Randomised Clinical Trial Study.

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • The correct ventricular catheter position (on post op CT) after single ventricular puncture. [ Time Frame: 48 h after initial operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of catheter changes [ Time Frame: at hospital discharge, expected to be after 10 days ] [ Designated as safety issue: No ]
  • Number of infections [ Time Frame: at hospital discharge, expected to be after 10 days ] [ Designated as safety issue: No ]
  • Number of days in clinic [ Time Frame: at hospital discharge, expected to be after 10 days ] [ Designated as safety issue: No ]
  • Number of ventricular punctures [ Time Frame: "at the end of the operation, expected to be after 1 hour" ] [ Designated as safety issue: No ]
  • Number of patients with intracerebral hemorrhage [ Time Frame: 24 h after initial operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ultrasound guided arm Procedure: Ultrasound guided ventricular drain insertion
Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.
Landmark-based arm Procedure: landmark-based ventricular drain insertion
Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01973764

Contacts
Contact: Jürgen Beck, MD 0041316322414 juergen.beck@insel.ch

Locations
Switzerland
Dep. of Neurosurgery, Bern University Hospital Not yet recruiting
Bern, Switzerland, 3000
Contact: Nicole B Porz, MD    0041 31 632 78 67    nicole.porz@insel.ch   
Contact: Anna K Krähenbühl, MD    0041 31 632 24 09    ak.kraehenbuehl@insel.ch   
Principal Investigator: Anna K Krähenbühl, MD         
Sub-Investigator: Janine Abu-Isa, MD         
Sub-Investigator: Astrid JilchMD         
Sub-Investigator: Nicole B Porz, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Jürgen Beck, MD Dep. of Neurosurgery, University Hospital Bern
Study Director: Andreas Raabe, MD Dep. of Neurosurgery, University Hospital
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01973764     History of Changes
Other Study ID Numbers: 073/13
Study First Received: October 25, 2013
Last Updated: October 31, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
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.

Additional relevant MeSH terms:
Hydrocephalus
Hypertension
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014