Effect of Percutaneous Internal Jugular Vein Catheterization on Intracranial Pressure in Patients With Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Intracranial Pressure (ICP)
研究概览
简要总结
Acute brain injury (ABI) is a serious condition that can cause a dangerous increase in pressure inside the skull (called intracranial pressure, or ICP), which can harm the brain. Patients with ABI often need a central venous catheter (CVC) - a small, flexible tube placed into a large neck vein - to receive medications, fluids, and to monitor their circulation. However, placing this catheter might temporarily affect brain pressure, either because of the patient's head position during the procedure or the procedure itself. The effect size and duration are not yet known.
The purpose of this observational study is to understand how placing a CVC in the neck (internal jugular vein) affects brain pressure in patients with acute brain injury. The study will closely monitor changes in brain pressure, blood flow, and oxygen levels in the brain during and immediately after the procedure. The study will also examine whether the brain's ability to regulate its own blood flow (called cerebral autoregulation) influences these changes.
This prospective, observational study will enroll approximately 100-120 adult patients with ABI who are in the Intensive Care Unit (ICU) and need a CVC as part of their regular medical care. The study will be conducted in two large hospitals in China. There is no experimental treatment or intervention; only observation and data recording during the standard medical procedure will be performed.
The main goal is to measure how brain pressure changes during CVC insertion. The study will also look at how long any changes last and whether the brain's blood flow regulation is affected. The results will help doctors better understand the risks of this common procedure and guide safer management of ABI patients in the ICU.
详细描述
Study Design This is a prospective, multicenter, observational cohort study. The study will be conducted in two intensive care units (ICUs) in China: Beijing Tiantan Hospital (primary center) and Guiyang Second People's Hospital (collaborating center). No experimental intervention is administered; all procedures are part of routine clinical care.
Population and Enrollment A total of 100-120 adult patients (≥18 years) with acute brain injury who require invasive intracranial pressure (ICP) monitoring and are scheduled for percutaneous internal jugular vein catheterization (central venous catheter, CVC) will be enrolled. Enrollment is expected to take 24 months (from March 2026 to February 2028). (Specific etiologies are not listed here as they are detailed in the Eligibility Criteria section.)
Exposure The exposure of interest is the performance of percutaneous internal jugular vein catheterization using the Seldinger technique. The procedure is performed by the patient's primary medical team according to institutional standards, with the patient lying supine, head turned to the contralateral side, and a shoulder roll placed if needed. Ultrasound guidance may be used at the operator's discretion.
Multimodal Monitoring
All enrolled patients already have an ICP monitor in place as part of clinical management (Codman microtransducer or external ventricular drain). Additionally, the following neuromonitoring parameters will be recorded continuously before, during, and after the CVC procedure:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admitted to the ICU with acute brain injury (including traumatic brain injury, spontaneous intracerebral hemorrhage, large hemispheric infarction, or aneurysmal subarachnoid hemorrhage) and ICU stay ≥ 24 hours
- •Invasive intracranial pressure (ICP) monitoring in place as part of clinical care
- •Scheduled to undergo percutaneous internal jugular vein catheterization (central venous catheter) as determined by the treating physician
- •Written informed consent obtained from the patient or legally authorized representative
排除标准
- •Informed consent not obtained
- •Intracranial pressure (ICP) > 22 mmHg within the past 48 hours
- •Any contraindication to internal jugular catheterization exists (severe coagulopathy with INR > 1.5 or platelets < 50×10⁹/L; neck infection, tumor, prior surgery or anatomical abnormality on either side; or bilateral jugular veins already catheterized)
- •Pregnancy or breastfeeding
结局指标
主要结局
Change in Intracranial Pressure (ICP)
时间窗: Baseline (immediately pre-procedure) to 30 minutes after catheter placement.
Change in ICP (mmHg) from baseline during and after percutaneous internal jugular vein catheterization. A clinically significant ICP elevation is defined as ≥22 mmHg sustained for more than 5 minutes.
次要结局
- Change in Cerebral Perfusion Pressure (CPP)(Measured from baseline to 30 minutes post-procedure.)
- Change in Regional Cerebral Oxygen Saturation (rSO₂)(Baseline to 30 minutes after catheter placement.)
- Change in Bispectral Index (BIS)(Baseline to 30 minutes after catheter placement.)
- Change in Cerebral Autoregulation Index(Measured from baseline to 30 minutes post-procedure.)
- Incidence of Delayed Cerebral Ischemia (DCI)(From enrollment to hospital discharge, assessed up to 30 days.)
- In-hospital all-cause mortality(From enrollment to hospital discharge, assessed up to 30 days.)
研究者
Jianfang Zhou
Associate Chief Physician
Beijing Tiantan Hospital