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

NCT01973764 | Terminated

• 1 other identifier: 073/13
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

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

  48 h after initial operation

Secondary Outcomes (5)

• Number of catheter changes

  at hospital discharge, expected to be after 10 days

• Number of infections

  at hospital discharge, expected to be after 10 days

• Number of days in clinic

  at hospital discharge, expected to be after 10 days

• Number of ventricular punctures

  "at the end of the operation, expected to be after 1 hour"

• Number of patients with intracerebral hemorrhage

  24 h after initial operation

Study Arms (2)

Ultrasound guided arm

OTHER

Procedure: Ultrasound guided ventricular drain insertion

Landmark-based arm

OTHER

Procedure: landmark-based ventricular drain insertion

Interventions

Ultrasound guided ventricular drain insertion PROCEDURE

Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.

Ultrasound guided arm

landmark-based ventricular drain insertion PROCEDURE

Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.

Landmark-based arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18 years
• Intraventricular catheter insertion or/and intraventricular pressure measurement indicated
• Written informed consent

You may not qualify if:

• Age \< 18 years
• previous ventricular punction \< 4 weeks
• bedside puncture indicated

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3000, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 19934980 RESULT

• 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.

  PMID: 7057239 RESULT

• 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.

  PMID: 8151359 RESULT

• 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.

  PMID: 18173315 RESULT

• 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.

  PMID: 23330995 RESULT

• 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.

  PMID: 11077095 RESULT

• 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.

  PMID: 17041512 RESULT

MeSH Terms

Conditions

Hydrocephalus; Intracranial Hypertension; Brain Edema

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jürgen Beck, MD

  Dep. of Neurosurgery, University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Andreas Raabe, MD

  Dep. of Neurosurgery, University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 1, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

CH (1)