Stealth-Guided EVD Placement for Intracranial Hypertension

Overseen By Azam Ahmed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Age, Prisoner, High risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Baseline

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for placing a tube in the brain to drain fluid for individuals with brain pressure issues. Typically, doctors perform this procedure manually, using only the outside of the head for guidance, which sometimes requires multiple attempts. The trial compares this traditional method to using a special imaging tool called AxiEM Stealth, which provides an internal view of the head to aid in more accurate tube placement. Individuals needing this procedure, known as EVD placement (External Ventricular Drain), and who have a compatible scan, might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance the accuracy and safety of EVD placement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the AxiEM Stealth Image Guidance is safe for EVD placement?

Research has shown that using AxiEM Stealth image guidance for placing external ventricular drains (EVD) in brain surgery is generally well-tolerated. This method is already used in operating rooms due to its accuracy and precision. The technology aids surgeons by aligning CT or MRI brain images with the patient's anatomy, enhancing catheter placement accuracy and potentially reducing complication risks.

Studies on similar procedures indicate that image guidance can improve safety by helping surgeons avoid critical brain areas and blood vessels. Few reports of negative effects have emerged when using this technology, suggesting it is a safe option. However, like any procedure, some risk remains, but the available data suggests it is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the Axium Stealth Image Guidance technique because it promises to enhance the accuracy of EVD catheter placement for intracranial hypertension. Unlike the traditional freehand method, which relies heavily on a surgeon's skill and anatomical landmarks, this technique uses advanced image guidance to precisely locate the ventricles. This could lead to fewer placement attempts, reduced risk of bleeding, and overall better outcomes for patients. The potential for improved precision and safety at the bedside is what makes this approach stand out.

What evidence suggests that AxiEM Stealth Image Guidance is effective for EVD placement?

This trial will compare two methods for external ventricular drain (EVD) placement. Research has shown that the AxiEM Stealth image guidance system, one of the methods under study, can enhance accuracy. When doctors use this image guidance during surgery, they often achieve better precision and encounter fewer complications. Studies suggest that this method may reduce the number of attempts needed to place the catheter correctly and could also lower the risk of post-procedure bleeding. This imaging technology is promising because it helps doctors see exactly where to place the catheter, potentially leading to better patient outcomes. ^{1 3 4 6 7}

Who Is on the Research Team?

Azam Ahmed

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 88 needing an external ventricular drain (EVD) placed, as decided by their doctor. They must be able to give consent or have a family member who can, and have a Stealth-compatible head CT or MRI. It's not for minors, prisoners, those at high medical risk as determined by the physician, emergency EVD placements without standard consent, pregnant women, or non-English speakers.

Inclusion Criteria

Patients undergoing bedside external ventricular drain placement determined by attending physician

Patients or consentable family member must sign a written informed consent prior to EVD placement

Stealth compatible head CT or MRI

Exclusion Criteria

Prisoner status

Subjects determined to be medically or neurologically to high of a risk for the study, determined by attending physician

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Comparison of freehand EVD catheter placement to AxiEM Stealth image-guided placement

Baseline

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of catheter durability and occurrence of post-placement hemorrhage

12 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Axium Steatlh Image Guidance
• EVD placement

Trial Overview The study compares traditional freehand placement of EVDs at the bedside with AxiEM Stealth image guidance—a method that uses patient-specific facial and scalp anatomy registered to CT or MRI images—to see if it improves accuracy and reduces complications.

How Is the Trial Designed?

Group I: Axium Stealth Image Guidance Experimental Treatment 2 Interventions

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.

Group II: EVD placement Active Control 1 Intervention

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.

EVD placement is already approved in European Union, United States, Canada, Japan, China for the following indications:

Approved in European Union as External Ventricular Drain for:

• Hydrocephalus
• Traumatic brain injury
• Subarachnoid hemorrhage
• Meningitis
• Brain tumors

Approved in United States as External Ventricular Drain for:

• Hydrocephalus
• Traumatic brain injury
• Subarachnoid hemorrhage
• Meningitis
• Brain tumors
• Intraventricular hemorrhage

Approved in Canada as External Ventricular Drain for:

• Hydrocephalus
• Traumatic brain injury
• Subarachnoid hemorrhage
• Meningitis
• Brain tumors

Approved in Japan as External Ventricular Drain for:

• Hydrocephalus
• Traumatic brain injury
• Subarachnoid hemorrhage
• Meningitis
• Brain tumors

Approved in China as External Ventricular Drain for:

• Hydrocephalus
• Traumatic brain injury
• Subarachnoid hemorrhage
• Meningitis
• Brain tumors

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

In a study analyzing 632 external ventricular drains (EVDs) inserted across 21 medical centers, it was found that 65.9% of the catheter tips were free-floating in cerebrospinal fluid, indicating a high rate of misplacement.

Despite the use of image guidance in only 19.6% of cases, this technique did not significantly improve catheter tip positioning or reduce blockage rates, suggesting that further education on its application is needed to enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of image-guided external ventriculostomy: analysis of contemporary practice in the United Kingdom and Ireland. McLean, AL., Jamjoom, AAB., Poon, MTC., et al.[2023]

A study of 579 patients showed that bedside bolt external ventricular drain (EVD) placement is a safe and accurate method, with 66.4% of EVD tips optimally placed, compared to 61.0% for tunneled EVDs.

Bolt EVDs are significantly more cost-effective, costing £260 per kit compared to £1316 for tunneled EVDs, making them a viable option for patients with hemorrhage-related hydrocephalus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Accuracy, and Cost Effectiveness of Bedside Bolt External Ventricular Drains (EVDs) in Comparison with Tunneled EVDs Inserted in Theaters. Roach, J., Gaastra, B., Bulters, D., et al.[2019]

In a study of 479 external ventricular drains (EVDs) placed in 409 patients, the overall infection rate was 2.2%, with coagulase-negative staphylococci being the most common pathogen identified.

Key risk factors for EVD infections included prior brain surgery related to cerebrospinal fluid (CSF) diversion, CSF leaks around the catheter, and dehiscence at the insertion site, while the duration of EVD use beyond 7 days did not significantly increase infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors and outcomes associated with external ventricular drain infections. Walek, KW., Leary, OP., Sastry, R., et al.[2023]

In a study of 83 patients with external ventricular drains (EVDs), it was found that sampling the EVD more than once does not increase the risk of ventriculostomy-associated infections (VAIs), with an odds ratio of 0.47 indicating a lower risk.

Significant risk factors for VAIs included cerebrospinal fluid (CSF) leaks, concurrent infections, and EVD duration longer than 10 days, highlighting the importance of monitoring these conditions to reduce infection risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent sampling and ventriculostomy-associated infections: a case-control study. Thompson, DR., Vlachos, S., Patel, S., et al.[2019]

Electromagnetic neuronavigation guidance for external ventricular drain (EVD) placement significantly improved accuracy, achieving a 94.7% success rate in correct placements compared to a 42.9% misplacement rate with the freehand technique.

The use of navigation guidance also reduced the average number of passes required for EVD insertion, with a mean of 1.16 passes compared to 1.63 for the freehand method, indicating a more efficient procedure for severe traumatic brain injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement accuracy of external ventricular drain when comparing freehand insertion to neuronavigation guidance in severe traumatic brain injury. AlAzri, A., Mok, K., Chankowsky, J., et al.[2018]

The use of ultrasound-guided techniques for external ventricular drain (EVD) placement at the bedside allows for customized catheter trajectories, improving the accuracy of placement in challenging anatomical situations.

In three illustrative cases, ultrasound helped identify critical anatomical features in real-time, enabling successful EVD placements even in cases of unexpected complications or distorted anatomy, demonstrating its potential to enhance safety and efficacy in neurosurgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategic placement of bedside ventriculostomies using ultrasound image guidance: report of three cases. Phillips, SB., Gates, M., Krishnamurthy, S.[2021]

In a retrospective analysis of external ventricular drains (EVDs) placed from 2008 to 2013, three patients developed pseudoaneurysms due to EVD placement, highlighting that while EVDs are generally safe, they can lead to serious vascular injuries.

Endovascular treatment, using techniques like coil and glue embolization, was successfully employed to manage these pseudoaneurysms, demonstrating that effective repair options exist for EVD-associated cerebrovascular injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endovascular management of external ventricular drain-associated cerebrovascular injuries. Choudhri, O., Gupta, M., Feroze, AH., et al.[2022]

In a study of 138 patients, EVD placements in the operating room (OR) had significantly lower complication rates (6.7%) compared to those placed in the intensive care unit (ICU) (21.5%), suggesting that OR placements may be safer.

No infections occurred in patients who received pre-placement antibiotics, indicating that antibiotic prophylaxis may enhance safety during EVD procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External ventricular drain placement in the intensive care unit versus operating room: evaluation of complications and accuracy. Foreman, PM., Hendrix, P., Griessenauer, CJ., et al.[2019]

In a study of 389 patients who underwent external ventricular drain (EVD) placement, the infection rate was found to be low at 3.1%, indicating that while EVD placement is generally safe, there are specific risk factors for infection.

Independent predictors of ventriculostomy-associated infection (VAI) included female sex, EVD replacement, increased cerebrospinal fluid (CSF) output per day, and the presence of a CSF leak, suggesting that monitoring these factors could help reduce infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of ventriculostomy infection in a large single-center cohort. Sweid, A., Weinberg, JH., Abbas, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03696043

External Ventricular Drain Placement Stealth Study This study will compare the current standard of care of freehand placement of bedside external ventricular catheters to the placement of EVD catheters with ...

2. withpower.com withpower.com/trial/phase-7-2018-e2300

Stealth-Guided EVD Placement for Intracranial Hypertension This trial compares traditional freehand placement of brain catheters with a new method using the AxiEM Stealth image guidance system.

3. medtronic.com medtronic.com/se-sv/healthcare-professionals/products/neurological/surgical-navigation-imaging/neurosurgery-imaging-surgical-navigation.html

Neurosurgery Imaging and Surgical Navigation Neurosurgery imaging and neuronavigation systems from Medtronic may help to improve clinical outcomes for neurosurgical procedures and therapies.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182322/

Developing a “Fast-Track” Strategy for Interventional ... Fulminant IIH, defined as a precipitous decline in visual function within 4 weeks of diagnosis, has been reported in less than 10% of patients ...

5. vumc.org vumc.org/periop-services/sites/default/files/public_files/9733792_06_SYNERGY_CRANIAL_AXIEM_PG.pdf

Synergy® Cranial AXIEM™ Pocket Guide Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11654647/

Guided Brain Lesion Biopsies: An Institution Based ... This retrospective study examines accuracy and safety of this AXIEM™-based free-hand frameless biopsy technique in the management of deep brain space-occupying ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6863785/

A management algorithm for patients with intracranial ... A management algorithm for patients with intracranial pressure monitoring: the Seattle International Severe Traumatic Brain Injury Consensus Conference (SIBICC)