Intracranial HypertensionARANEDNCT06571539
Augmented Reality-Assisted Neurosurgical Drain Placement
A study testing AR-assisted EVD placement and Freehand EVD placement in people with Intracranial Hypertension, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- AR-assisted EVD placement and Freehand EVD placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Aug 2021to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other cranial intervention(s) expected within the first 24h after EVD placement
- EVD placement in the OR using a craniotome and/or conventional neuronavigation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-worn Navigation System
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?
Read more
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).
Read the 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
- Being tested
- AR-assisted EVD placement, Freehand EVD placement
- Keywords
- Augmented reality, Neuronavigation, Computer-assisted surgery, Ventricular drain placement, Ventriculostomy
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-assisted EVD placementDevice
Cfr. arm description
Freehand EVD placementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AR-assisted EVD placement; Procedure: Freehand EVD placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24 hours after surgery
Secondary outcomes (3)
Required attempts
The number of attempts required for successful ventricular puncture
Measured: During surgery
Procedure-related complications
The amount and type of complications related to the EVD placement procedure (e.g. hemorrhage, infection)
Measured: Within 7 days after surgery
Revision rate
The amount of revisions required in case of non-functional EVD placement
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start29 Aug 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Imec, Orsi Academy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571539
- Sponsor's protocol ID
- UZB-ARANED-1
- Acronym
- ARANED
- Status last verified
- Nov 2018
- First submitted
- 31 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data obtained through this study may be provided upon request to qualified researchers with academic interest in AR guidance for EVD placement. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. For request approval and following investigator support, contact Dr. Frederick Van Gestel (frederick.vangestel@uzbrussel.be).
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-accuracy Augmented Reality Guidance for Intracranial Drain Placement Using a Standalone Head-worn Navigation System
- ClinicalTrials.gov ID
- NCT06571539
- Acronym / sponsor ID
- ARANED / UZB-ARANED-1
- Conditions
- Intracranial Hypertension
- Keywords
- Augmented reality, Neuronavigation, Computer-assisted surgery, Ventricular drain placement, Ventriculostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Imec, Orsi Academy
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| AR-assisted EVD placement | Experimental | Device: AR-assisted EVD placement, Procedure: Freehand EVD placementExternal ventricular drain (EVD) placement using a standalone augmented reality (AR) headset equipped with high-accuracy inside-out infrared tracking and software addressing EVD placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Other cranial intervention(s) expected within the first 24h after EVD placement
- EVD placement in the OR using a craniotome and/or conventional neuronavigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-assisted EVD placementCfr. arm description | Device | AR-assisted EVD placement |
| Freehand EVD placementExternal 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. | Procedure or surgery | AR-assisted EVD placement |
Primary outcome
Clinical EVD placement quality
Time frame: 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).
3 secondary outcomes
Required attempts
Time frame: During surgery
Procedure-related complications
Time frame: Within 7 days after surgery
Revision rate
Time frame: Within 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Yes. Deidentified participant data obtained through this study may be provided upon request to qualified researchers with academic interest in AR guidance for EVD placement. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. For request approval and following investigator support, contact Dr. Frederick Van Gestel (frederick.vangestel@uzbrussel.be).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR-assisted EVD placement and Freehand EVD placement in people with Intracranial Hypertension, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical EVD placement quality (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.