External Ventricular DrainNCT06139289
A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room
An observational study of External Ventricular Drain, run by Methodist Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- External Ventricular Drain
- What is being tested?
- EVD placements in the OR versus the bedside.
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 21 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients ≥18 years old Any patient undergoing EVD placement at MDMC between January 2018 and August 2022
Who may be able to join
- • Patients ≥18 years old
- Any patient undergoing EVD placement at MDMC between January 2018 and August 2022
Who cannot join
- • Any patient not meeting criteria in section 3.1
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
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.
Read the 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).
- Conditions
- External Ventricular Drain
- Being tested
- EVD placements in the OR versus the bedside.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVD placements in the OR versus the bedside.Procedure or surgery
Also called EVD placement environment
Reducing EVD-related complications
What is being measured
The primary outcome is the main question the study is designed to answer.
EVD Placement Success
development of best-practice recommendations for future EVD placements
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Sep 2022
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for External Ventricular DrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Meyrat, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139289
- Sponsor's protocol ID
- 102.MBSI.2022.D
- Status last verified
- Jul 2025
- First submitted
- 14 Nov 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
Publications
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.
PubMed 25436470
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room
- ClinicalTrials.gov ID
- NCT06139289
- Acronym / sponsor ID
- 102.MBSI.2022.D
- Conditions
- External Ventricular Drain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years old Any patient undergoing EVD placement at MDMC between January 2018 and August 2022
Key inclusion criteria (2 listed)
- • Patients ≥18 years old
Key exclusion criteria (1 listed)
- • Any patient not meeting criteria in section 3.1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVD placements in the OR versus the bedside.Also: EVD placement environmentReducing EVD-related complications | Procedure or surgery | – |
Primary outcome
EVD Placement Success
Time frame: 30 Days
development of best-practice recommendations for future EVD placements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 25436470Foreman 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.
- Individual participant dataSharing planned: Yes. Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
Related trials for External Ventricular Drain
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Early Lumbar Drainage for Intraventricular Hemorrhage
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Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
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Effect of Implementing External Ventricular Drain Guidelines on Nurses' Practice and Traumatic Brain Injury Patients' Outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Meyrat, MD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of External Ventricular Drain, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVD Placement Success (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06139289, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.