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

Hydrocephalus Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01973764
• Other study ID #: 073/13
• Status: Terminated
• Phase: N/A
• Start date: November 2013
• Est. completion date: May 2019

Study information

• Verified date: August 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hypertension
• Intracranial Hypertension

Intervention

Procedure:
• Ultrasound guided ventricular drain insertion
Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.
• 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.

Locations

Country	Name	City	State
Switzerland	Dep. of Neurosurgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (7)

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 — View 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. — View 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. — View Citation

Sekhar LN, Moossy J, Guthkelch AN. Malfunctioning ventriculoperitoneal shunts. Clinical and pathological features. J Neurosurg. 1982 Mar;56(3):411-6. — View 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. — View 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. — View 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.JNS1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correct ventricular catheter position (on post op CT) after single ventricular puncture.		48 h after initial operation
Secondary	Number of catheter changes		at hospital discharge, expected to be after 10 days
Secondary	Number of infections		at hospital discharge, expected to be after 10 days
Secondary	Number of days in clinic		at hospital discharge, expected to be after 10 days
Secondary	Number of ventricular punctures		"at the end of the operation, expected to be after 1 hour"
Secondary	Number of patients with intracerebral hemorrhage		24 h after initial operation