Clinical trial NCT06571539: Augmented Reality-Assisted Neurosurgical Drain Placement
Official title: High-accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-worn Navigation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hypertension
Keywords: Augmented reality
Neuronavigation
Computer-assisted surgery
Ventricular drain placement
Ventriculostomy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Imec
name: Orsi Academy
First posted: 2024-08-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective clinical pilot study with the goal to assess feasibility, safety and clinical performance of high-accuracy AR-guided EVD placement using a standalone head-worn navigation system in critical care settings at the Universitair Ziekenhuis Brussel over the course of one year.

Consecutive sample (n=11) of adult patients requiring EVD placement, performed with AR guidance; compared to a matched (for quantity, intervention, performing surgeons, and timeframe), non-concurrent freehand control group (n=11, retrospective outcome analysis without active enrollment to receive study treatment).
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if high-accuracy augmented reality (AR) guidance for external ventricular drain (EVD) placement using a standalone head-worn navigation system can improve current shortcomings of freehand and image-guidance techniques. It will assess safety, feasibility and clinical performance. The main questions it aims to answer are:

* Is the implementation of a standalone head-worn AR navigation system for EVD placement in critical care settings feasible and safe?
* How does it compare to the conventional freehand technique in terms of EVD placement quality, complication rate and revision rate?

Researchers will assess placement quality using the modified Kakarla scale, grading placement quality based on the position of the EVD tip on postoperative CT imaging. The amount of attempts, complications and revisions will be documented. The results of the AR-guided placements will be compared to a matched, non-concurrent freehand control group.

Participants will undergo AR-guided EVD placement in a critical care setting (i.e. the emergency room or intensive care unit).

Detailed description: External ventricular drain (EVD) placement is often performed using the freehand technique. In comparison to image-guided methods, this technique was identified as the primary risk factor of improper outcome, yielding optimal placement in only 70%. While conventional image guidance technologies introduce a distinct improvement in accuracy, these systems tend to be prohibitively large and lack mobility, restricting their use to the operating room. As such, their practical implementation in critical care settings is not always feasible due to time, availability, and cost constraints.

This study aims to address shortcomings in both conventional EVD placement and current image guidance technologies. To achieve this, first an AR headset-based navigation system was developed, providing high-accuracy inside-out infrared tracking and software features specifically focusing on EVD placement. Phantom studies were conducted, which proved successful, with a positive outcome of AR-guided EVD placement on phantom heads over the freehand technique. Given these results, the researchers aim to test the system in a clinical trial setting.

Given the additional layer of information on top of knowledge and experience regarding the freehand technique, it is hypothesized that AR guidance will result in an improved outcome, as was the case for conventional neuronavigation.

This study is a prospective clinical pilot study, with the goal to assess feasibility, safety and clinical performance of high-accuracy AR-guided EVD placement using a standalone head-worn navigation system in critical care settings at the Universitair Ziekenhuis Brussel over the course of one year. The outcome will be quantified using the modified Kakarla scale to assess EVD placement quality on postoperative CT imaging, as well as the amount of attempts, complications and revisions. The results of the AR-guided placements will be compared to a non-concurrent control group of matched (for quantity, intervention, performing surgeons and timeframe) freehand EVD placement cases that will be collected retrospectively.

The study protocol was approved by the Ethics Committee of the Universitair Ziekenhuis Brussel (ref. 2018/447) and validated by the Belgian Federal Agency of Medicines and Health Products (FAGG/AFMPS ref. 80M0764).

Eligibility criteria: Inclusion Criteria:

* Adult patient
* Indication for bedside EVD placement in a critical care setting (emergency room or intensive care unit) using a twistdrill
* EVD placement as sole cranial intervention

Exclusion Criteria:

* Other cranial intervention(s) expected within the first 24h after EVD placement
* EVD placement in the OR using a craniotome and/or conventional neuronavigation

Primary outcomes:
measure: Clinical EVD placement quality
timeFrame: Within 24 hours after surgery
Secondary outcomes:
measure: Required attempts
timeFrame: During surgery
measure: Procedure-related complications
timeFrame: Within 7 days after surgery
measure: Revision rate
timeFrame: Within 24 hours after surgery
Other outcomes:
measure: Subjective technology experience
timeFrame: Within 7 days after inclusion of the last patient
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References: