Augmented Reality-Assisted Neurosurgical Drain Placement

Not Applicable

Completed

• Conditions: Intracranial Hypertension
• Interventions: Device: AR-assisted EVD placement; Procedure: Freehand EVD placement

• Registration Number: NCT06571539
• Lead Sponsor: Universitair Ziekenhuis Brussel

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).

Study Timeline

• Status Verified: 2018-11
• Study Start: 2021-08-29
• Primary Completion: 2022-08-30
• Study Completion: 2023-08-30
• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AR-assisted EVD placement	AR-assisted EVD placement	External ventricular drain (EVD) placement using a standalone augmented reality (AR) headset equipped with high-accuracy inside-out infrared tracking and software addressing EVD placement.
AR-assisted EVD placement	Freehand EVD placement	External ventricular drain (EVD) placement using a standalone augmented reality (AR) headset equipped with high-accuracy inside-out infrared tracking and software addressing EVD placement.

Primary Outcome Measures

Name	Time	Method
Clinical EVD placement quality	Within 24 hours after surgery	External ventricular drain (EVD) placement quality assessment using the modified Kakarla scale (mKS; with grades I (a and b), II and III), grading placement quality based on the EVD tip position (identified on the postoperative CT imaging) from optimal placement (mKS grade Ia) to poor or failed placement (mKS grade III).

Secondary Outcome Measures

Name	Time	Method
Revision rate	Within 24 hours after surgery	The amount of revisions required in case of non-functional EVD placement
Procedure-related complications	Within 7 days after surgery	The amount and type of complications related to the EVD placement procedure (e.g. hemorrhage, infection)
Required attempts	During surgery	The number of attempts required for successful ventricular puncture

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium