Evaluating the position of external ventricular drain catheters during surgery
Intra-operative Evaluation of the External Ventricular Drain Catheter Position With Structured Light
This study is testing a new method for placing drainage tubes in the brain during surgery to see if it can help doctors position them more accurately and improve patient safety.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05931991 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the placement of external ventricular drainage (EVD) catheters, a critical procedure for relieving elevated intracranial pressure. It aims to validate a novel technology called Bullseye EVD, which provides a structured light method for verifying catheter positioning during emergency procedures. The study addresses the high rate of malpositioning associated with traditional freehand techniques, which can lead to complications such as infection and the need for revision. By improving the accuracy of catheter placement, the study seeks to enhance patient outcomes in critical care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to undergo EVD placement and have pre-procedural head CT imaging.
Not a fit: Patients for whom the setup time for the procedure poses a safety risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the rates of catheter malpositioning and associated complications in patients requiring EVD placement.
How similar studies have performed: While the approach of using structured light for catheter positioning is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Cari Whyne, PHD, FIOR — Sunnybrook Health Sciences Centre
- Study coordinator: Cari Whyne, PhD, FIOR
- Email: cari.whyne@sunnybrook.ca
- Phone: 416-480-6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.