- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07682987
Effect of Implementing External Ventricular Drain Guidelines on Nurses' Practice and Traumatic Brain Injury Patients' Outcomes
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Al Mansurah, Egypt
- Faculty of Nursing- Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External Ventricular Drain Guidelines
external ventricular drain guidelines: mandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation.
|
mandatory checks, hourly documentation, leveling the EVD system, dressing changes, removal of the EVD, CSF sampling, ICP monitoring and documentation.
|
|
No Intervention: control group
it will recieve routine care including Assessing the EVD level and dressing care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cerebrospinal fluid
Time Frame: 4 months
|
Absence of CSF leakage from the site of insertion.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 689
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ohio State UniversityIRRASRecruitingSubarachnoid Hemorrhage | Intraventricular Hemorrhage | Ventriculitis | Subdural HematomaUnited States
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