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External Ventricular Drain Placement Stealth Study

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ClinicalTrials.gov Identifier: NCT03696043
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
External Ventricular Drain Intracranial Pressure Other: Axium Steatlh Image Guidance Other: EVD placement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Application of Image Guidance Technology to Bedside External Ventricular Drain Placement
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: EVD placement
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
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.

Experimental: Axium Stealth Image Guidance
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
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.

Other: EVD placement
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.




Primary Outcome Measures :
  1. Number of catheter passes or attempts [ Time Frame: baseline ]
    Collection of number of passes needed for successful catheter placement

  2. Accuracy of catheter tip compared to foramen of Monro [ Time Frame: baseline ]
    Measurement of accuracy for catheter tip compared to foramen of Monro with accuracy formula


Secondary Outcome Measures :
  1. Occurrence of post-placement hemorrhage [ Time Frame: baseline and 12 months ]
    Anotation of occurrence of hemorrhage post-catheter placement by either freehand or image guided

  2. New neurological deficits [ Time Frame: baseline and 12 months ]
    Utilization of the Glasgow Come Score and mRS scale to measure new neurological symptoms

  3. Durability of EVD [ Time Frame: baseline and 12 months ]
    Presence of clogging/ failure

  4. Time required catheter insertion [ Time Frame: baseline ]
    Anotation of time allocation for catheter insertion - both methods

  5. Infection rate [ Time Frame: baseline and 12 months ]
    Occurrence of ventriculostomy infection (meningitis, ventriculitis, cerebritis)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696043


Contacts
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Contact: Azam Ahmed, MD 608-263-0485 azam.ahmed@neurosurgery.wisc.edu
Contact: Daniel Burkett, MD 608-263-0485 burkett@neurosurgery.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Azam Ahmed, MD    608-263-0485    azam.ahmed@neurosurgery.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Azam Ahmed, MD University of Wisconsin, Madison

Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03696043     History of Changes
Other Study ID Numbers: 2017-1487
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
intracranial pressure
external ventricular drain
cerebrospinal fluid