A Review of External Ventricular Drain Placement at the B... | NCT06139289

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

NCT06139289

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Jul 28, 2025Actual

Enrollment

200Actual

Phase

Not provided

Conditions

External Ventricular Drain

Interventions

EVD placements in the OR versus the bedside.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2022Actual

Primary Completion Date

Jul 21, 2025Actual

Completion Date

Jul 21, 2025Actual

First Submitted Date

Nov 14, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2025

Last Update Posted Date

Jul 28, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVD placements in the OR versus the bedside.	Procedure	Reducing EVD-related complications		EVD placement environment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EVD Placement Success	development of best-practice recommendations for future EVD placements	30 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients ≥18 years old Any patient undergoing EVD placement at MDMC between January 2018 and August 2022

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Meyrat, MD	Methodist Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center		Dallas	Texas	75203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25436470	Background	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.