Augmented Reality-Assisted Neurosurgical Drain Placement

NCT06571539 | Completed DMC

• 1 other identifier: UZB-ARANED-1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracranial Hypertension

Keywords

Augmented reality; Neuronavigation; Computer-assisted surgery; Ventricular drain placement; Ventriculostomy

Outcome Measures

Primary Outcomes (1)

• Clinical EVD placement quality

  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).

  Within 24 hours after surgery

Secondary Outcomes (3)

• Required attempts

  During surgery

• Procedure-related complications

  Within 7 days after surgery

• Revision rate

  Within 24 hours after surgery

Other Outcomes (1)

• Subjective technology experience

  Within 7 days after inclusion of the last patient

Study Arms (1)

AR-assisted EVD placement

EXPERIMENTAL

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.

Device: AR-assisted EVD placement; Procedure: Freehand EVD placement

Interventions

AR-assisted EVD placement DEVICE

Cfr. arm description

AR-assisted EVD placement

Freehand EVD placement 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.

AR-assisted EVD placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• Imec: collaborator
• Orsi Academy: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 26, 2024
• Study Start: August 29, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2023
• Last Updated: August 26, 2024

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted after publication of a resulting manuscript. If approved, data will be made accessible for up to 12 months, with the possibility of extension considered on a case-by-case basis.
• Access Criteria: Requests for IPD access can be submitted by qualified researchers pursuing academic or independent scientific research on AR guidance for EVD placement. Following review of the proposed data use (through a research proposal and SAP), approval may be granted after which a data sharing agreement will be set up. For more information or to submit a request, please contact Dr. Frederick Van Gestel (frederick.vangestel@uzbrussel.be).

Locations

BE (1)