Effect of Internal Jugular Vein Catheterization on Intracranial Pressure and Intracranial Blood Flow

Official title

Effect of Internal Jugular Vein Catheterization on Intracranial Pressure Assessed by Optic Nerve Sheath Diameter and Carotid Doppler Ultrasonography: a Prospective Observational Study

Overview

This prospective observational study aims to evaluate the effect of internal jugular vein catheterization on intracranial pressure using optic nerve sheath diameter (ONSD) measurements and carotid artery Doppler ultrasonography in adult patients undergoing surgery under general anesthesia. ONSD will be measured noninvasively using transorbital ultrasonography, and carotid Doppler parameters will be assessed at two time points: after endotracheal intubation and approximately 5 minutes after catheterization. The primary objective is to assess short-term changes in ONSD following catheterization. Secondary objectives include evaluating changes in carotid Doppler measurements and their relationship with ONSD, as well as associations with physiological parameters such as blood pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide.

Detailed description

This prospective observational study is designed to investigate the effect of internal jugular vein catheterization on intracranial pressure using noninvasive ultrasonographic methods in adult patients undergoing elective surgery.

Internal jugular vein catheterization will be performed as part of routine clinical care in patients requiring central venous access. The study does not introduce any additional intervention beyond standard clinical practice.

Intracranial pressure will be indirectly assessed by measuring optic nerve sheath diameter (ONSD) using transorbital ultrasonography with a high-frequency linear probe. Measurements will be obtained at a standardized depth of 3 mm posterior to the optic disc.

In addition, carotid artery Doppler ultrasonography will be performed to assess hemodynamic parameters, including flow velocities and derived indices.

All ultrasonographic measurements will be performed at two predefined time points: after endotracheal intubation and approximately 5 minutes following internal jugular vein catheterization. Measurements will be obtained from the side of catheterization.

The primary outcome is the change in ONSD following internal jugular vein catheterization. Secondary outcomes include changes in carotid Doppler parameters and their relationship with ONSD, as well as associations with physiological variables such as blood pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide.

Ultrasonographic assessments are noninvasive and considered safe, with no known risk to participants. All data will be collected prospectively and analyzed to evaluate short-term physiological changes associated with the procedure.

Interventions

• Procedure Internal Jugular Vein Catheterization
  Internal jugular vein catheterization is performed in patients undergoing major surgical procedures when clinically indicated as part of routine perioperative care. The procedure is not assigned by the study. Additional non-invasive ultrasound measurements, including optic nerve sheath diameter assessment, are obtained to evaluate physiological changes associated with catheterization without altering standard clinical management. Ultrasonography is a non-invasive and safe imaging method routinel

Primary outcome measures

• Change in Optic Nerve Sheath Diameter (mm) Following Internal Jugular Vein Catheterization [Time frame: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization]

Secondary outcome measures (8)

• Change in Internal Carotid Artery Peak Systolic Velocity (PSV) Following Internal Jugular Vein Catheterization [Time frame: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization]
• Change in Internal Carotid Artery End-Diastolic Velocity (EDV) Following Internal Jugular Vein Catheterization [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in Internal Carotid Artery Time-Averaged Maximum Velocity (TAMAX) Following Internal Jugular Vein Catheterization [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in Internal Carotid Artery Pulsatility Index (PI) Following Internal Jugular Vein Catheterization [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in Internal Carotid Artery Systolic/Diastolic Ratio (S/D) Following Internal Jugular Vein Catheterization [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in Mean Arterial Pressure (MAP) [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in Heart Rate [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]
• Change in End-Tidal Carbon Dioxide (EtCO₂) [Time frame: Baseline and 5 minutes after internal jugular vein catheterization]

Eligibility criteria

Inclusion criteria

• Age ≥18 years
• Patients undergoing surgery under general anesthesia
• Patients requiring internal jugular vein catheterization as part of routine clinical care
• Ability to obtain optic nerve sheath diameter measurements using transorbital ultrasonography
• Provision of informed consent

Exclusion criteria

• Known intracranial pathology affecting intracranial pressure
• Ocular conditions preventing accurate ultrasonographic measurement (e.g., orbital trauma, ocular surgery, infection)
• Hemodynamic instability
• Contraindication to internal jugular vein catheterization
• Inability to obtain adequate ultrasound images

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital — Istanbul

Publications

• Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17. PMID 30019201
• Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20. PMID 21505900
• Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29. PMID 18509619

Identifiers

NCT: NCT07540481 · IJVC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗