A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

External Ventricular Drain Clinical Trial

Official title:

A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06139289
• Other study ID #: 102.MBSI.2022.D
• Status: Active, not recruiting
• Start date: September 19, 2022
• Est. completion date: September 19, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.

Description:

External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus. While generally regarded as safe, EVDs are associated with a significant risk of complications, such as hemorrhage, infection, and improper placement resulting in a need for replacement and the patient undergoing an additional procedure.

Significant research has been conducted reducing these complications, with a major focus on issues with the procedure itself, instruments utilized for EVD placement, or post-procedure care of the EVD. To the knowledge, few investigations have focused on the EVD placement environment ( the operating room versus the bedside). Aim to evaluate the circumstances and complications rates associated with EVD placement between these two settings at Methodist Dallas Medical Center (MDMC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 19, 2024
• Est. primary completion date: September 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• • Patients =18 years old

• Any patient undergoing EVD placement at MDMC between January 2018 and August 2022

Exclusion Criteria:

• • Any patient not meeting criteria in section 3.1

Related Conditions & MeSH terms

• External Ventricular Drain

Intervention

Procedure:
• EVD placements in the OR versus the bedside.
Reducing EVD-related complications

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Foreman PM, Hendrix P, Griessenauer CJ, Schmalz PG, Harrigan MR. External ventricular drain placement in the intensive care unit versus operating room: evaluation of complications and accuracy. Clin Neurol Neurosurg. 2015 Jan;128:94-100. doi: 10.1016/j.clineuro.2014.09.026. Epub 2014 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EVD Placement Success	development of best-practice recommendations for future EVD placements	30 Days