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

NCT07704528 | Active Not Recruiting DMC

• 1 other identifier: HX-B-2026001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Acute Brain Injury; Traumatic Brain Injury; Intracerebral Hemorrhage; Aneurysmal Subarachnoid Hemorrhage (aSAH); Intracranial Hypertension; Central Venous Catheter

Keywords

Acute brain injury; Intracranial hypertension; Central Venous Catheter

Outcome Measures

Primary Outcomes (1)

• Change in Intracranial Pressure (ICP)

  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.

  Baseline (immediately pre-procedure) to 30 minutes after catheter placement.

Secondary Outcomes (6)

• 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.

Study Arms (1)

ABI patients undergoing internal jugular vein catheterization

Adult patients (≥18 years) with acute brain injury (including traumatic brain injury, intracerebral hemorrhage, large hemispheric infarction, and aneurysmal subarachnoid hemorrhage) who require invasive intracranial pressure monitoring and are scheduled to undergo percutaneous internal jugular vein catheterization (central venous catheter) as part of routine clinical care. No experimental intervention is administered; the exposure of interest is the catheterization procedure itself.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with acute brain injury (including traumatic brain injury, spontaneous intracerebral hemorrhage, large hemispheric infarction, and aneurysmal subarachnoid hemorrhage) who require invasive intracranial pressure monitoring and are scheduled for clinically indicated percutaneous internal jugular vein catheterization. Patients with ICP \>22 mmHg within 48 hours prior to the procedure, contraindications to jugular catheterization (e.g., severe coagulopathy, local neck pathology, bilateral catheters already in place), or who are pregnant/breastfeeding are excluded. The study population is recruited from two ICUs in China (Beijing Tiantan Hospital and Guiyang Second People's Hospital).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (2)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

The Second People's Hospital of Guiyang

Guiyang, Guizhou, 550081, China

Location

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: July 15, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)