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

Primary Purpose

Hydrocephalus, Intracranial Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultrasound guided ventricular drain insertion
landmark-based ventricular drain insertion
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydrocephalus focused on measuring 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.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Neurosurgery, Bern University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Ultrasound guided arm

Landmark-based arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of catheter changes
Number of infections
Number of days in clinic
Number of ventricular punctures
Number of patients with intracerebral hemorrhage

Full Information

First Posted
October 25, 2013
Last Updated
August 28, 2019
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT01973764
Brief Title
Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System
Acronym
In-Vent
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to slow recruitment
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided arm
Arm Type
Other
Arm Title
Landmark-based arm
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided ventricular drain insertion
Intervention Description
Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.
Intervention Type
Procedure
Intervention Name(s)
landmark-based ventricular drain insertion
Intervention Description
Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.
Primary Outcome Measure Information:
Title
The correct ventricular catheter position (on post op CT) after single ventricular puncture.
Time Frame
48 h after initial operation
Secondary Outcome Measure Information:
Title
Number of catheter changes
Time Frame
at hospital discharge, expected to be after 10 days
Title
Number of infections
Time Frame
at hospital discharge, expected to be after 10 days
Title
Number of days in clinic
Time Frame
at hospital discharge, expected to be after 10 days
Title
Number of ventricular punctures
Time Frame
"at the end of the operation, expected to be after 1 hour"
Title
Number of patients with intracerebral hemorrhage
Time Frame
24 h after initial operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Beck, MD
Organizational Affiliation
Dep. of Neurosurgery, University Hospital Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Raabe, MD
Organizational Affiliation
Dep. of Neurosurgery, University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Neurosurgery, Bern University Hospital
City
Bern
ZIP/Postal Code
3000
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19934980
Citation
Toma AK, Camp S, Watkins LD, Grieve J, Kitchen ND. External ventricular drain insertion accuracy: is there a need for change in practice? Neurosurgery. 2009 Dec;65(6):1197-200; discussion 1200-1. doi: 10.1227/01.NEU.0000356973.39913.0B.
Results Reference
result
PubMed Identifier
7057239
Citation
Sekhar LN, Moossy J, Guthkelch AN. Malfunctioning ventriculoperitoneal shunts. Clinical and pathological features. J Neurosurg. 1982 Mar;56(3):411-6. doi: 10.3171/jns.1982.56.3.0411.
Results Reference
result
PubMed Identifier
8151359
Citation
Pang D, Grabb PA. Accurate placement of coronal ventricular catheter using stereotactic coordinate-guided free-hand passage. Technical note. J Neurosurg. 1994 Apr;80(4):750-5. doi: 10.3171/jns.1994.80.4.0750.
Results Reference
result
PubMed Identifier
18173315
Citation
Huyette DR, Turnbow BJ, Kaufman C, Vaslow DF, Whiting BB, Oh MY. Accuracy of the freehand pass technique for ventriculostomy catheter placement: retrospective assessment using computed tomography scans. J Neurosurg. 2008 Jan;108(1):88-91. doi: 10.3171/JNS/2008/108/01/0088.
Results Reference
result
PubMed Identifier
23330995
Citation
Wilson TJ, Stetler WR Jr, Al-Holou WN, Sullivan SE. Comparison of the accuracy of ventricular catheter placement using freehand placement, ultrasonic guidance, and stereotactic neuronavigation. J Neurosurg. 2013 Jul;119(1):66-70. doi: 10.3171/2012.11.JNS111384. Epub 2013 Jan 18.
Results Reference
result
PubMed Identifier
11077095
Citation
Strowitzki M, Moringlane JR, Steudel W. Ultrasound-based navigation during intracranial burr hole procedures: experience in a series of 100 cases. Surg Neurol. 2000 Aug;54(2):134-44. doi: 10.1016/s0090-3019(00)00267-6.
Results Reference
result
PubMed Identifier
17041512
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.
Results Reference
result

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

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