Improving the placement of external ventricular drains using advanced imaging guidance
Application of Image Guidance Technology to Bedside External Ventricular Drain Placement
NA · University of Wisconsin, Madison · NCT03696043
This study is testing a new imaging technology to see if it can help doctors place external ventricular drains more accurately for adults with high pressure in their brains.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT03696043 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of Axium Stealth Image Guidance technology to enhance the accuracy of external ventricular drain (EVD) placement in patients with increased intracranial pressure. EVDs are critical for monitoring intracranial pressure and draining cerebrospinal fluid in conditions such as hydrocephalus and trauma. The study aims to reduce complications associated with traditional freehand placement techniques by utilizing imaging guidance to ensure precise catheter positioning. Participants will be adults undergoing EVD placement, and the study will assess the effectiveness of this approach compared to standard methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 88 who require bedside EVD placement as determined by their attending physician.
Not a fit: Patients who are under 18 or over 88 years old, or those who are unable to provide consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective EVD placements, reducing complications and improving patient outcomes.
How similar studies have performed: While traditional EVD placement techniques have been widely used, the application of advanced imaging guidance in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin-Madison — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Azam Ahmed, MD — University of Wisconsin, Madison
- Study coordinator: Azam Ahmed, MD
- Email: azam.ahmed@neurosurgery.wisc.edu
- Phone: 608-263-0485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: External Ventricular Drain, Intracranial Pressure, intracranial pressure, external ventricular drain, cerebrospinal fluid