University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Turkey (Türkiye)
Location contact
Aysun Edehan, MD
CONTACT
Ayça Sultan Şahin, Prof Dr
CONTACT
NCT Number: NCT07540481
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.
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Get Notified18 year and older
All sexes
Observational
Istanbul, Turkey (Türkiye)
Aysun Edehan, MD
CONTACT
Ayça Sultan Şahin, Prof Dr
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 routinely used in clinical practice.
Time frame: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization
Optic nerve sheath diameter (ONSD) will be measured in millimeters using transorbital ultrasonography at 3 mm posterior to the optic disc on the side of catheterization. The outcome is defined as the difference between measurements obtained immediately after endotracheal intubation (baseline) and 5 minutes after internal jugular vein catheterization. Higher values indicate increased optic nerve sheath diameter.
Time frame: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization
Peak systolic velocity (PSV) of the internal carotid artery will be measured in cm/s using Doppler ultrasonography. The outcome is defined as the difference between post-intubation (baseline) and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
End-diastolic velocity (EDV) of the internal carotid artery will be measured in cm/s using Doppler ultrasonography. The outcome is defined as the difference between post-intubation and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
Time-averaged maximum velocity (TAMAX) will be measured in cm/s using Doppler ultrasonography. The outcome is defined as the difference between post-intubation and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
Pulsatility index (PI) will be calculated from Doppler measurements (unitless). The outcome is defined as the difference between post-intubation and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
The systolic/diastolic (S/D) ratio will be calculated from Doppler measurements (unitless). The outcome is defined as the difference between post-intubation and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
Mean arterial pressure (MAP) will be measured in mmHg. The outcome is defined as the difference between post-intubation (baseline) and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
Heart rate will be measured in beats per minute (bpm). The outcome is defined as the difference between post-intubation and post-catheterization values.
Time frame: Baseline and 5 minutes after internal jugular vein catheterization
End-tidal carbon dioxide (EtCO₂) will be measured in mmHg. The outcome is defined as the difference between post-intubation and post-catheterization values.
Contact information is provided by the study sponsor or research team.
Aysun Edehan, MD
CONTACT
Ayça Sultan Şahin, Prof. Dr.
CONTACT
Kanuni Sultan Suleyman Training and Research Hospital
Other
Effect of Internal Jugular Vein Catheterization on Intracranial Pressure Assessed by Optic Nerve Sheath Diameter and Carotid Doppler Ultrasonography: a Prospective Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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