Recruiting

Bullseye EVD

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05931991

Conditions

Intracranial Pressure Increase

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05931991

Start date

Jul 7, 2023

Status verified date

May, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥18 years of age
2. Scheduled to undergo placement of an EVD
3. Located in B5 ICU or CRCU
4. Existing pre-procedural head CT imaging

Exclusion Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Accuracy of the structured light computer vision system [ Time Frame: Data analysis to start immediately post procedure. ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Cari Whyne, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 9, 2024

Last verified

May, 2024

Keywords

  • External Ventricular Drain
  • Intracranial Pressure
  • EVD malpositioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-05-09.