- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540481
Effect of Internal Jugular Vein Catheterization on Intracranial Pressure and Intracranial Blood Flow
Effect of Internal Jugular Vein Catheterization on Intracranial Pressure Assessed by Optic Nerve Sheath Diameter and Carotid Doppler Ultrasonography: a Prospective Observational Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayça Sultan Şahin, Prof. Dr.
- Phone Number: +905323100840
- Email: aycasultan@gmail.com
Study Contact Backup
- Name: Aysun Edehan, MD
- Phone Number: +905309127017
- Email: aysn.997@gmail.com
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
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Contact:
- Aysun Edehan, MD
- Phone Number: +905309127017
- Email: aysn.997@gmail.com
-
Contact:
- Ayça Sultan Şahin, Prof Dr
- Phone Number: +905323100840
- Email: aycasultan@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult Patients Undergoing Internal Jugular Vein Catheterization
Adults undergoing elective surgery under general anesthesia who require internal jugular vein catheterization as part of routine clinical care.
Intracranial pressure will be assessed noninvasively using optic nerve sheath diameter measurements obtained before and after 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 routinely used in clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
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Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
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Baseline and 5 minutes after internal jugular vein catheterization
|
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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
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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.
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Baseline and 5 minutes after internal jugular vein catheterization
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Change in Internal Carotid Artery Pulsatility Index (PI) Following Internal Jugular Vein Catheterization
Time Frame: Baseline and 5 minutes after internal jugular vein catheterization
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Pulsatility index (PI) will be calculated from Doppler measurements (unitless).
The outcome is defined as the difference between post-intubation and post-catheterization values.
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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
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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.
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Baseline and 5 minutes after internal jugular vein catheterization
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Change in Mean Arterial Pressure (MAP)
Time Frame: Baseline and 5 minutes after internal jugular vein catheterization
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Mean arterial pressure (MAP) will be measured in mmHg.
The outcome is defined as the difference between post-intubation (baseline) and post-catheterization values.
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Baseline and 5 minutes after internal jugular vein catheterization
|
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Change in Heart Rate
Time Frame: Baseline and 5 minutes after internal jugular vein catheterization
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Heart rate will be measured in beats per minute (bpm).
The outcome is defined as the difference between post-intubation and post-catheterization values.
|
Baseline and 5 minutes after internal jugular vein catheterization
|
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Change in End-Tidal Carbon Dioxide (EtCO₂)
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.
|
Baseline and 5 minutes after internal jugular vein catheterization
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IJVC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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