Augmented Reality-Assisted Neurosurgical Drain Placement

NCT ID: NCT06571539

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-29
• Study Completion Date: 2023-08-30

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).

Conditions

Intracranial Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AR-assisted EVD placement

Intervention Type: DEVICE

Cfr. arm description

Freehand EVD placement

Intervention Type: PROCEDURE

External ventricular drain (EVD) placement using the conventional freehand technique. This intervention covers the matched, non-concurrent control group, retrospectively obtained without active enrollment to receive study treatment.

Interventions

AR-assisted EVD placement

Cfr. arm description

Intervention Type: DEVICE

Freehand EVD placement

External ventricular drain (EVD) placement using the conventional freehand technique. This intervention covers the matched, non-concurrent control group, retrospectively obtained without active enrollment to receive study treatment.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Imec

INDUSTRY

Sponsor Role: collaborator

Orsi Academy

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Jette, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UZB-ARANED-1

Identifier Type: -

Identifier Source: org_study_id