External Ventricular Drain Placement Stealth Study

Description

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

Study Overview

Study Details

Study overview

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.

Application of Image Guidance Technology to Bedside External Ventricular Drain Placement

External Ventricular Drain Placement Stealth Study

Condition
External Ventricular Drain
Intervention / Treatment

-

Contacts and Locations

Madison

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 88 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Wisconsin, Madison,

Azam Ahmed, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

2025-12