Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients (NCT07704528) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients
China120 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is actively enrolling but no longer recruiting new participants, is there any chance I could still be considered, or is that window completely closed for someone in my situation?
2This trial is looking at how placing a central venous catheter affects intracranial pressure — given that I already have elevated brain pressure, what does my doctor think about whether that procedure could be risky or beneficial in my specific case?
3Because this trial is listed as 'Phase NA,' meaning it's more of an observational or procedural study rather than a drug trial testing new treatments, can my doctor explain what participating would actually involve for me day-to-day and whether it changes my standard care at all?
4Since the main thing being measured is the change in intracranial pressure during catheter placement, would my doctor be monitoring my ICP in any special way as part of this study that I wouldn't otherwise receive?
5Are there standard-of-care approaches to managing my intracranial pressure that my doctor would recommend pursuing first, rather than or alongside participation in this type of observational study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Intracranial Pressure (ICP)
Timeframe: Baseline (immediately pre-procedure) to 30 minutes after catheter placement.