Image Guided EVD Placement

NCT05639036 | Withdrawn

• 1 other identifier: 15534
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

Conditions

External Ventricular Drain (EVD); Image Guidance

Outcome Measures

Primary Outcomes (1)

• Study Feasibility

  Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)

  8 months

Secondary Outcomes (3)

• Accuracy of external ventricular drain (EVD) placement

  8 months

• Number of attempts

  8 months

• Complications

  8 months

Study Arms (2)

Control-Free Hand External Ventricular Drain Placement

ACTIVE COMPARATOR

This group will receive an external ventricular drain placed using the standard free-hand technique

Procedure: Free Hand External Ventricular Drain Placement

Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System

EXPERIMENTAL

This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system

Device: Image Guided External Ventricular Drain Placement Using the NAV3 System

Interventions

Image Guided External Ventricular Drain Placement Using the NAV3 System DEVICE

Nav3 image guidance system used to assist with external ventricular drain placement

Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System

Free Hand External Ventricular Drain Placement PROCEDURE

External ventricular drain will be placed with the standard free-hand technique

Control-Free Hand External Ventricular Drain Placement

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients requiring EVD placement
• patients who can safely and reasonably be randomized to either study arm
• patients with available pre-procedural head CT
• written/verbal consent obtained

You may not qualify if:

• patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)
• scenarios where the EVD must be inserted immediately and there is not time to obtain consent
• scenarios where bedside image guidance system (NAV3) is unavailable
• subjects medically or neurologically unstable to obtain pre-EVD CT scan
• EVD revisions on ipsilateral side during same admission

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

• Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0.

  PMID: 18728595 BACKGROUND

• Aljoghaiman M, Bergen B, Takroni R, Wang B, Eangles P, Farrokhyar F, Sharma S. Image-Guided versus Freehand Ventricular Drain Insertion: Systematic Review and Meta-analysis. World Neurosurg. 2022 Apr;160:85-93.e5. doi: 10.1016/j.wneu.2022.01.036. Epub 2022 Jan 13.

  PMID: 35033689 BACKGROUND

Study Officials

• Dr. Kesava Reddy

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 6, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 1, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)