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临床试验/NCT07682987
NCT07682987进行中(未招募)不适用

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
86
试验地点
1
主要终点
cerebrospinal fluid

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

cerebrospinal fluid

时间窗: 4 months

Absence of CSF leakage from the site of insertion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Fadel Ali Mohammed Yousef

Assistant Lecturer

Mansoura University

研究点 (1)

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