Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light for Patients (Bullseye EVD)

NCT05931991 | Recruiting

• 1 other identifier: Bullseye EVD
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The placement of external ventricular drainage (EVD) is a life-saving procedure used to relieve high pressures in the brain. Often performed at the bedside, a small tube (catheter) is inserted into one ventricle of the brain to drain cerebrospinal fluid and release the pressure build up. In standard practice, EVDs are placed freehand and initial catheter malpositioning occurs in up to \~60% of procedures. Currently, there are no adequate means to verify the position of the catheter before insertion which is a significant impediment to ensure accurate positioning. This non-interventional study aims to validate a novel technology, Bullseye EVD, for verifying the position of the EVD catheter during these emergency procedures.

Conditions

Intracranial Pressure Increase

Keywords

External Ventricular Drain; Intracranial Pressure; EVD malpositioning

Outcome Measures

Primary Outcomes (1)

• Accuracy of the structured light computer vision system

  The primary study outcome will be the accuracy of the structured light computer vision system. This will be quantified as the difference between predicted and actual position of the EVD catheter measured as a combined analysis of version error (degrees), inclination error (degrees), and offset error (mm).

  Data analysis to start immediately post procedure.

Secondary Outcomes (3)

• Procedural time for Fiducial placement and optical imaging

  Time measured during procedure

• Workflow integration

  Immediately after procedure

• User feedback

  Immediately after procedure

Eligibility Criteria

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

Study Population

A total of 15 patients will be enrolled in this study at Sunnybrook Health Sciences Centre's ICU. The PI, study team members who are part of the circle of care, and study personnel will identify potential study participants. The Research Coordinator or assistant will approach for consent. Given that the clinical procedure involved- the EVD- is an urgent procedure with short timelines, s deferred consent model may also be used in this study as it satisfies the conditions for deferred consent as set out in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans - TCPS 2 (2022) Article 3.7A,.

You may qualify if:

• ≥18 years of age
• Scheduled to undergo placement of an EVD
• Located in B5 ICU or CRCU
• Existing pre-procedural head CT imaging

You may not qualify if:

• \. Set up time poses a safety risk (Clinical discretion)

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cari Whyne, PHD, FIOR

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cari Whyne, PhD, FIOR

CONTACT

416-480-6100; cari.whyne@sunnybrook.ca

Katrine Milner

CONTACT

416-480-4285; Orthores@Sunnybrook.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior scientist, PhD,FIOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 6, 2023
• Study Start: July 7, 2023
• Primary Completion: March 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)