RECRUITING

External Ventricular Drain Placement Stealth Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Application of Image Guidance Technology to Bedside External Ventricular Drain Placement

Quick Facts

Study Start:2018-08-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03696043

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.

Ages Eligible for Study:18 Years to 88 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing bedside external ventricular drain placement determined by attending physician
  2. * Age ≥ 18 years and ≤ 88 years
  3. * Male or Female
  4. * Patients or consentable family member must sign a written informed consent prior to EVD placement
  5. * Stealth compatible head CT or MRI
  1. * Patients ≤ 18 and ≥ 88 years of age
  2. * Prisoner status
  3. * Subjects who decline participation into the study
  4. * Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician
  5. * Patients who undergo emergent EVD placement via emergency consent
  6. * Subjects for whom self-consent or consent by a LAR cannot be obtained or cannot be obtained
  7. * Pregnant women
  8. * Non-English speaking patients

Contacts and Locations

Study Contact

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

Principal Investigator

Azam Ahmed, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2018-08-15
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • intracranial pressure
  • external ventricular drain
  • cerebrospinal fluid

Additional Relevant MeSH Terms

  • External Ventricular Drain
  • Intracranial Pressure