External Ventricular Drain Placement Stealth Study

NCT03696043 | Terminated

• 4 other identifiers: 2017-1487A535700SMPH/NEURO SURG/NEURO SURGProtocol Version 8/8/2024
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

External ventricular drain (EVD) placement is performed very often in neurosurgical practices. EVD's are most commonly placed at the bedside using external anatomical landmarks to guide the catheter into the frontal horn of the ipsilateral lateral ventricle. EVDs are often placed due to acute neurological compromise and require timely insertion. Accurate catheter placement is essential to achieving effective external CSF drainage without complications or occlusion/failure of the catheter. Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent. Current methods for EVD placement do not compensate for superficial brain vessels or pathology that may alter the intracranial anatomy such as trauma, hemorrhage, or mass lesions. Some studies have attempted to use CTA imaging to identify intracranial vessels in an attempt to avoid them during placement. Image guidance is a tool used very commonly for placement of EVD's and shunts in the operating room. AxiEM Stealth is a noninvasive image localization modality that registers a CT or MRI to the individual patients facial and scalp anatomy. This study will compare the current standard of care of freehand placement of bedside external ventricular catheters to the placement of EVD catheters with AxiEM Stealth image guidance.

Conditions

External Ventricular Drain; Intracranial Pressure

Keywords

intracranial pressure; external ventricular drain; cerebrospinal fluid

Outcome Measures

Primary Outcomes (2)

• Number of catheter passes or attempts

  Collection of number of passes needed for successful catheter placement

  baseline

• Accuracy of catheter tip compared to foramen of Monro

  Measurement of accuracy for catheter tip compared to foramen of Monro with accuracy formula

  baseline

Secondary Outcomes (5)

• Occurrence of post-placement hemorrhage

  baseline and 12 months

• New neurological deficits

  baseline and 12 months

• Durability of EVD

  baseline and 12 months

• Time required catheter insertion

  baseline

• Infection rate

  baseline and 12 months

Study Arms (2)

EVD placement

ACTIVE COMPARATOR

Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent.

Other: EVD placement

Axium Stealth Image Guidance

EXPERIMENTAL

The novelty of this study is to investigate whether using image guidance technology can improve EVD catheter placement. Image guidance is used very commonly for EVD and shunt placement in the operating room with excellent accuracy and precision. We hypothesize that using this same workflow at the bedside will improve accuracy; decrease the number of passes needed for a successful placement, decrease the number of post-placement hemorrhagic events, and help improve the effectiveness of the catheter as well as patient outcomes.

Other: Axium Steatlh Image Guidance; Other: EVD placement

Interventions

Axium Steatlh Image Guidance OTHER

The Axiem Stealth imaging guidance system uses a probe (AxiEM Registration Probe) and a side mount emitter (AxiEM Side Mount Emitter) to register the patient's head in relation to the probe. A trajectory (entry point and target) is then planned. This registration process takes an estimated 5-15 minutes to perform. A separate stylet (StealthStation EM Stylet) is designed specifically for the catheter and slides down the center of the catheter. A burr-hole is created at the predefined precise location and the catheter is passed to the target under electromagnetic guidance.

Axium Stealth Image Guidance

EVD placement OTHER

A sterile field is prepared about 10-12 centimeters posterior to the eye and about 2-3 cm lateral to the midline of the skull. An incision is made at this point and a burr hole is created using a hand drill. The catheter is advanced in a trajectory perpendicular to the skull, which results in a direction that is towards the ipsilateral medial canthus and ipsilateral tragus which are other landmarks that can be used.

Axium Stealth Image Guidance; EVD placement

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing bedside external ventricular drain placement determined by attending physician
• Age ≥ 18 years and ≤ 88 years
• Male or Female
• Patients or consentable family member must sign a written informed consent prior to EVD placement
• Stealth compatible head CT or MRI

You may not qualify if:

• Patients ≤ 18 and ≥ 88 years of age
• Prisoner status
• Subjects who decline participation into the study
• Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician
• Patients who undergo emergent EVD placement via emergency consent
• Subjects for whom self-consent or consent by a LAR cannot be obtained or cannot be obtained
• Pregnant women
• Non-English speaking patients

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (7)

• Patil V, Lacson R, Vosburgh KG, Wong JM, Prevedello L, Andriole K, Mukundan S, Popp AJ, Khorasani R. Factors associated with external ventricular drain placement accuracy: data from an electronic health record repository. Acta Neurochir (Wien). 2013 Sep;155(9):1773-9. doi: 10.1007/s00701-013-1769-y. Epub 2013 May 23.

  PMID: 23700258 BACKGROUND

• Mahan M, Spetzler RF, Nakaji P. Electromagnetic stereotactic navigation for external ventricular drain placement in the intensive care unit. J Clin Neurosci. 2013 Dec;20(12):1718-22. doi: 10.1016/j.jocn.2013.03.005. Epub 2013 Aug 30.

  PMID: 23993898 BACKGROUND

• Patil V, Gupta R, San Jose Estepar R, Lacson R, Cheung A, Wong JM, Popp AJ, Golby A, Ogilvy C, Vosburgh KG. Smart stylet: the development and use of a bedside external ventricular drain image-guidance system. Stereotact Funct Neurosurg. 2015;93(1):50-8. doi: 10.1159/000368906. Epub 2015 Jan 31.

  PMID: 25662506 BACKGROUND

• Sarrafzadeh A, Smoll N, Schaller K. Guided (VENTRI-GUIDE) versus freehand ventriculostomy: study protocol for a randomized controlled trial. Trials. 2014 Dec 5;15:478. doi: 10.1186/1745-6215-15-478.

  PMID: 25480528 BACKGROUND

• Robertson FC, Abd-El-Barr MM, Mukundan S Jr, Gormley WB. Ventriculostomy-associated hemorrhage: a risk assessment by radiographic simulation. J Neurosurg. 2017 Sep;127(3):532-536. doi: 10.3171/2016.8.JNS16538. Epub 2016 Dec 2.

  PMID: 27911234 BACKGROUND

• Alan N, Lee P, Ozpinar A, Gross BA, Jankowitz BT. Robotic Stereotactic Assistance (ROSA) Utilization for Minimally Invasive Placement of Intraparenchymal Hematoma and Intraventricular Catheters. World Neurosurg. 2017 Dec;108:996.e7-996.e10. doi: 10.1016/j.wneu.2017.09.027. Epub 2017 Sep 14.

  PMID: 28919568 BACKGROUND

• Wang A, Tenner MS, Tobias ME, Mohan A, Kim D, Tandon A. A Novel Approach Using Electromagnetic Neuronavigation and a Flexible Neuroendoscope for Placement of Ommaya Reservoirs. World Neurosurg. 2016 Dec;96:195-201. doi: 10.1016/j.wneu.2016.08.127. Epub 2016 Sep 5.

  PMID: 27609447 BACKGROUND

Study Officials

• Azam Ahmed, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Target of 100 participants - 50% freehand EVD placement and 50% image guided EVD placement. Randomization is every other patient will received image guided EVD placement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Target of 100 participants - 50% freehand EVD placement and 50% image guided EVD placement. Randomization is every other patient will received image guided EVD placement

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: October 4, 2018
• Study Start: August 15, 2018
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)