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Clinical Trials in China / NCT07704528
Active, not recruiting Observational

Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients

NCT07704528 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Observational
Started
2026-03-01
Last updated
2026-07-15

Condition(s) studied

Acute Brain InjuryTraumatic Brain InjuryIntracerebral HemorrhageAneurysmal Subarachnoid Hemorrhage (aSAH)Intracranial HypertensionCentral Venous Catheter

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Intracranial Pressure (ICP) — 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.

Trial sites (2)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Capital Medical University Beijing Beijing Municipality
The Second People's Hospital of Guiyang Guiyang Guizhou

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07704528 on ClinicalTrials.gov ↗ ← All trials in China