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.
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.
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).
- Conditions
- Brain Injuries,Traumatic
- 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 group | Role | What they receive |
|---|---|---|
| External Ventricular Drain Guidelines | Experimental | external 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 group | No intervention | it 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.
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.
- First posted6 Jul 2026
- Study start7 Sep 2025
- Primary completion7 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries,TraumaticStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Fadel Ali Mohammed Yousef, Mansoura University
- Investigators
- Ali, Principal investigator, Mansoura University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implementing External Ventricular Drain Guidelines on Nurses' Practice and Traumatic Brain Injury Patients' Outcomes
- ClinicalTrials.gov ID
- NCT07682987
- Acronym / sponsor ID
- 689
- Conditions
- Brain Injuries,Traumatic
- Keywords
- External Ventricular Drain Guidelines, Nurses' Practice, Traumatic Brain Injury Patients' Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 7 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Jul 2026 (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.
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
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Ventricular Drain Guidelines | Experimental | Other: External Ventricular Drain Guidelinesexternal ventricular drain guidelines: mandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation. |
| control group | No intervention | –it will recieve routine care including Assessing the EVD level and dressing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| External Ventricular Drain Guidelinesmandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation. | Other | External Ventricular Drain Guidelines |
Primary outcome
cerebrospinal fluid
Time frame: 4 months
Absence of CSF leakage from the site of insertion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Ali principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
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.