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Brain Injuries,TraumaticNCT07682987

Effect of Implementing External Ventricular Drain Guidelines on Nurses' Practice and Traumatic Brain Injury Patients' Outcomes

A study testing External Ventricular Drain Guidelines in people with Brain Injuries,Traumatic, run by Mansoura University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Neurosurgical patients are more vulnerable to infections related to medical care due to their requirement for surgically inserted devices like ventriculostomies and their extended hospital stays. Introduction of a foreign device can result in infection due to insertion technique as well as postinsertion management. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Injuries,Traumatic
What is being tested?
External Ventricular Drain Guidelines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
1 siteEgypt
Study dates
7 Sep 2025to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult traumatic brain injury patients ≥ 18 years old of each gender.
  • Hemodynamically stable patients.
  • Patients who are free from an EVD related complications within 24hours

Who cannot join

  • Bleeding from the site of EVD within 24hours.
  • Hypo and hyper drainage of CSF or CSF leakage from entry site within 24hours.
  • Signs of infection related to EVD such as (fever- headache- change in CSF characteristics).
  • Coagulation disorder and who receive anticoagulant drug.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Nursing- Mansoura University

    Al Mansurah

Other trials in Egypt

About this study

Neurosurgical patients are more vulnerable to infections related to medical care due to their requirement for surgically inserted devices like ventriculostomies and their extended hospital stays. Introduction of a foreign device can result in infection due to insertion technique as well as postinsertion management. Establishing protocols of ventriculostomy drain management tools to raise nurse awareness and adherence to the most recent standards of care may greatly lower the risk of health care-associated infection in the neurosurgical population.

Based on the high demand on information and technological resources, nurses must be qualified to ensure patient safety and make more assertive decisions. For this reason, it is imperative that these nurses possess the necessary knowledge and abilities to provide assistance. The purpose of training has evolved to encompass professional development, acquiring knowledge, and the teaching and practicing of new skills

Read the detailed description

Traumatic brain injury (TBI) remains a global public health challenge. It is a major cause of death and disability across all ages worldwide (World Health Organisation, 2018; American Association for Surgery of Trauma, 2018), with substantial socio-economic consequences (Kolias, Rubiano, Figaji, Servadei \& Hutchinson, 2019). The rising global incidence of TBI is attributable to the increase in road traffic collisions and trauma-related violence in low and middle-income countries. It causes death in more than five million people annually, representing approximately 10% of the global death toll (WHO, 2014). Major trauma is a main cause of admissions to intensive care units (ICU) and consumes a significant share of ICU resources (Menon, \& Ercole, 2017).

Traumatic brain injury can be divided into primary and secondary brain injury. The primary injury occurs because of the initial physical insult. The pattern and extent of damage will depend on the nature, intensity, and duration of the impact (Carlson et al., 2024). Following a primary injury, brain oedema, disturbed cerebrospinal fluid (CSF) dynamics, and the presence of mass lesions exhaust the volume buffering compensatory mechanism mediated by CSF drainage from brain cisterns to the spinal subarachnoid space and can lead to a rise in intracranial pressure (ICP) (Chau et al., 2019).

The subsequent increase in ICP and impaired autoregulation result in reduced cerebral perfusion, exacerbating cerebral ischemia, secondary brain injury, brain tissue compression, distortion, and herniation can ultimately lead to death (Alali et al., 2013). Therefore, control of ICP is an important factor in the medical and surgical management of TBI (Winkler, Minter, Yue, \& Manley, 2016).

External ventricular drainage is a lifesaving procedure experienced in neurocritical care units (Muralidharan, 2015). It is consisting of placing a catheter into the lateral ventricles of the brain to a collection system outside of the body with the purpose of diverting the CSF flow extra-cranially or to monitor ICP (Patil et al., 2013). After insertion, the EVD monitoring, maintenance and troubleshooting essentially become a nursing responsibility. Accurate and accountable nursing care may have the ability to portend better outcomes in patients requiring CSF drainage ( Mohamed Maarouf, \& Faltas Marzouk Faltas, 2020) .

The external ventricular drain (EVD) is a medical and health technology that serves both diagnostic and therapeutic purposes (Jamjoom et al., 2018). It is widely recognized as the preferred method and is considered the gold standard for treating certain neurological conditions such as hydrocephalus, intracranial hemorrhage, tumors, meningitis. By facilitating continuous monitoring and effectively reducing ICP. Although the EVD enables drug delivery, blood or CSF drainage, and CSF collection samples when required (Carney et al., 2017).

The utilization of EVD catheters combined with ICP monitoring has seen a notable rise. This monitoring technique enables the recording of ICP values and waveform patterns while maintaining continuous CSF drainage (Chau et al., 2019). External ventricular drain is contraindicated in patients who have a coagulation disorder, receive anticoagulant medication, or have a disease on their scalp or localized abscesses. This precaution is due to the significant risk of central nervous system infections, such as meningitis and ventriculitis (Sweet \& Foley, 2019).

The EVD system must be correctly levelled and closed to CSF drainage for an appropriate amount of time to provide a precise ICP reading, which is required to assess the brain's health (Liu et al, 2020). Adjusting the height of the collection chamber regulates the flow by increasing or decreasing the amount of pressure required for the CSF to drain . The CSF drainage is dependent on the balance between ICP and the height of the reservoir. Ventricular drainage can be used to assist with controlling increased ICP by providing a temporary exit for the CSF flow (Camacho et al, 2013).

Patients undergoing EVD may encounter various complications that can impact their wellbeing. These include the possibility of infection, which can be recognized by symptoms such as elevated body temperature, redness, or the discharge of fluid or secretion. System obstruction may be observed when the drainage of CSF falls below the expected minimum level or when the CSF waveform appears flat on the monitoring device. Another potential complication is excessive CSF drainage. Furthermore, EVD can result in bleeding, problems with the ventricles, or unintentional catheter removal, requiring neurosurgical interference (Aslam, Afzal, Sarwar, \& Khan, 2022).

Nurses who are competent in the assessment and care of patients with both neurological and drain conditions should keep a close eye on patients who need an EVD. Monitoring for symptoms and signs connected to changing ICP should be part of the patient assessment process. The registered nurse should conduct and record neurological examinations on an hourly basis. This includes measuring the mean ICP, CSF drainage, color, and clarity (Kumar, Malhotra, \& Bhatia, 2021).

Being tested
External Ventricular Drain Guidelines
Keywords
External Ventricular Drain Guidelines, Nurses' Practice, Traumatic Brain Injury Patients' Outcomes
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External Ventricular Drain GuidelinesOther

    mandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation.

Study groups in NCT07682987
Study groupRoleWhat they receive
External Ventricular Drain GuidelinesExperimentalexternal ventricular drain guidelines: mandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation.
Receives: Other: External Ventricular Drain Guidelines
control groupNo interventionit will recieve routine care including Assessing the EVD level and dressing care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cerebrospinal fluid

    Absence of CSF leakage from the site of insertion.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start7 Sep 2025
  3. Primary completion7 Sep 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07682987
Sponsor's protocol ID
689
Status last verified
Jun 2026
First submitted
28 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing External Ventricular Drain Guidelines in people with Brain Injuries,Traumatic, run by Mansoura University at 1 site in Egypt.

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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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?

cerebrospinal fluid (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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