Stealth-Guided EVD Placement for Intracranial Hypertension

Overseen by Azam Ahmed

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Age, Prisoner, High risk, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial compares traditional freehand placement of brain catheters with a new method using the AxiEM Stealth image guidance system. The goal is to see if using detailed images from CT or MRI scans can help doctors place the catheters more accurately and safely in patients with conditions like hydrocephalus or brain trauma.

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 data supports the effectiveness of the treatment Axium Stealth Image Guidance for EVD placement?

Research shows that using image-guided techniques, like Axium Stealth Image Guidance, for placing external ventricular drains (EVDs) can improve accuracy and reduce the number of attempts needed compared to traditional freehand methods. This suggests that the treatment may be more effective in ensuring proper placement and reducing complications. ^{1 2 3 4 5}

Is the Stealth-Guided EVD Placement generally safe for humans?

External ventricular drain (EVD) placement is a common procedure that can be life-saving, but it carries risks such as infections and potential injuries to blood vessels. Image-guided EVD placement, like the Stealth-Guided method, is considered safer and more accurate than traditional methods, potentially reducing the risk of complications. ^{4 5 6 7 8}

How is the Stealth-Guided EVD Placement treatment different from other treatments for intracranial hypertension?

Stealth-Guided EVD Placement is unique because it uses advanced imaging techniques like neuronavigation or ultrasound to guide the placement of the external ventricular drain, improving accuracy and reducing the risk of misplacement compared to traditional freehand methods. ^{1 2 5 7 9}

Research Team

Azam Ahmed

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

I am between 18 and 88 years old.

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

Exclusion Criteria

Prisoner status

Pregnant women

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

Trial Timeline

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)

Treatment Details

Interventions

• Axium Steatlh Image Guidance (Procedure)
• EVD placement (Procedure)

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.

Participant Groups

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 Canada, Japan, China for the following indications:

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+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States 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. [2019]

2. Austria pubmed.ncbi.nlm.nih.gov

Placement accuracy of external ventricular drain when comparing freehand insertion to neuronavigation guidance in severe traumatic brain injury. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of ventriculostomy infection in a large single-center cohort. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

Recurrent sampling and ventriculostomy-associated infections: a case-control study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Utility of image-guided external ventriculostomy: analysis of contemporary practice in the United Kingdom and Ireland. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Endovascular management of external ventricular drain-associated cerebrovascular injuries. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Risk factors and outcomes associated with external ventricular drain infections. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

External ventricular drain placement in the intensive care unit versus operating room: evaluation of complications and accuracy. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Strategic placement of bedside ventriculostomies using ultrasound image guidance: report of three cases. [2021]