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Procedure

Stealth-Guided EVD Placement for Intracranial Hypertension

N/A

Recruiting

Led By Azam Ahmed, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years and ≤ 88 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

Study Summary

This trial is testing whether using AxiEM Stealth image guidance to place external ventricular drains (EVDs) is better than the current standard of care, which is placing them using external anatomical landmarks.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed for this procedure-based trial, potential risks may include discomfort at the insertion site, infection risk from catheter placement, possible damage to surrounding brain tissue during insertion and inaccurate placement leading to ineffective drainage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 88 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Accuracy of catheter tip compared to foramen of Monro

Catheter device

Secondary outcome measures

Durability of EVD

Infection rate

New neurological deficits

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Axium Stealth Image GuidanceExperimental Treatment2 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 placementActive Control1 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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,183 Previous Clinical Trials

3,167,604 Total Patients Enrolled

Azam Ahmed, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

11 Total Patients Enrolled

Media Library

EVD placement (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03696043 — N/A

External Ventricular Drain Research Study Groups: EVD placement, Axium Stealth Image Guidance

External Ventricular Drain Clinical Trial 2023: EVD placement Highlights & Side Effects. Trial Name: NCT03696043 — N/A

EVD placement (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03696043 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of thirty capable of participating in this experiment?

"This medical study is open to adults aged 18 and over, with a maximum age cutoff of 88."

Answered by AI

Are individuals currently being enrolled for this research endeavor?

"Affirmative. Clinicaltrials.gov displays that this clinical trial is currently enrolling participants, having been announced on August 15th 2018 and updated most recently in December 6th 2022. The study requires 100 individuals to be recruited from a single location."

Answered by AI

What is the upper threshold of participants for this research trial?

"Affirmative. According to the information hosted on clinicaltrials.gov, this investigation is currently recruiting participants and was initially posted on August 15th 2018. The research needs 100 patients from a single medical centre for completion."

Answered by AI

Who meets the criteria to participate in this experimental research?

"This trial seeks to recruit 100 people aged between 18 and 88 that are suffering from increased intracranial pressure. The requirements for admission include being either male or female, requiring a bedside external ventricular drain placement as judged by their attending physician, and meeting the age criteria of at least 18 years old but not older than 88."

Answered by AI

What outcomes is the research team hoping to obtain from this investigation?

"The primary objective of this trial, evaluated over a pre-established period of time, is to measure the number of catheter passes and attempts. Secondary endpoints include recording how long it takes to insert the catheter via both approaches, noting any post-placement haemorrhaging, as well assessing for new neurological deficits by employing Glasgow Coma Score and mRS scales."

Answered by AI

Recent research and studies

Acta NeurochirurgicaJournal

Factors Associated with External Ventricular Drain Placement Accuracy: Data from an Electronic Health Record Repository

Patil, Vaibhav, Ronilda Lacson, Kirby G. Vosburgh, Judith M. Wong, Luciano Prevedello, Katherine Andriole, Srinivasan Mukundan, A. John Popp, and Ramin Khorasani. 2013. “Factors Associated with External Ventricular Drain Placement Accuracy: Data from an Electronic Health Record Repository”. Acta Neurochirurgica. Springer Science and Business Media LLC. doi:10.1007/s00701-013-1769-y.

Journal of Clinical NeuroscienceJournal

Electromagnetic Stereotactic Navigation for External Ventricular Drain Placement in the Intensive Care Unit

Mahan, Mark, Robert F. Spetzler, and Peter Nakaji. 2013. “Electromagnetic Stereotactic Navigation for External Ventricular Drain Placement in the Intensive Care Unit”. Journal of Clinical Neuroscience. Elsevier BV. doi:10.1016/j.jocn.2013.03.005.

Stereotactic and Functional NeurosurgeryJournal

Smart Stylet: The Development and Use of a Bedside External Ventricular Drain Image-guidance System

Patil, Vaibhav, Rajiv Gupta, Raúl San José Estépar, Ronilda Lacson, Arnold Cheung, Judith M. Wong, A. John Popp, Alexandra Golby, Christopher Ogilvy, and Kirby G. Vosburgh. 2015. “Smart Stylet: The Development and Use of a Bedside External Ventricular Drain Image-guidance System”. Stereotactic and Functional Neurosurgery. S. Karger AG. doi:10.1159/000368906.

Journal of NeurosurgeryJournal