Intracranial PressureNCT07540481
Effect of Internal Jugular Vein Catheterization on Intracranial Pressure and Intracranial Blood Flow
An observational study of Intracranial Pressure and Ultrasonography, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure, Ultrasonography
- What is being tested?
- Internal Jugular Vein Catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 16 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing surgical procedures under general anesthesia at a tertiary care hospital, in whom internal jugular vein catheterization is performed as part of routine clinical care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Istanbul
Ayça Sultan Şahin, Prof Dr, +905323100840, aycasultan@gmail.com
Aysun Edehan, MD, +905309127017, aysn.997@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Intracranial Pressure, Ultrasonography
- Being tested
- Internal Jugular Vein Catheterization
- Keywords
- Internal Jugular Vein, Catheterization, Ultrasonography, Optic Nerve Sheath Diameter, Intracranial Pressure, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Jugular Vein CatheterizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Internal Jugular Vein Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter (mm) Following 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.
Measured: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization
Secondary outcomes (8)
Change in Internal Carotid Artery Peak Systolic Velocity (PSV) Following 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.
Measured: 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
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.
Measured: 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-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.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Change in Internal Carotid Artery Pulsatility Index (PI) Following 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.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Change in Internal Carotid Artery Systolic/Diastolic Ratio (S/D) Following 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.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Change in Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) will be measured in mmHg. The outcome is defined as the difference between post-intubation (baseline) and post-catheterization values.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Change in Heart Rate
Heart rate will be measured in beats per minute (bpm). The outcome is defined as the difference between post-intubation and post-catheterization values.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Change in End-Tidal Carbon Dioxide (EtCO₂)
End-tidal carbon dioxide (EtCO₂) will be measured in mmHg. The outcome is defined as the difference between post-intubation and post-catheterization values.
Measured: Baseline and 5 minutes after internal jugular vein catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracranial PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun Edehan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540481
- Sponsor's protocol ID
- IJVC
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policies and concerns regarding patient confidentiality and data privacy. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approvals.
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.
PubMed 30019201Dubourg 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.
PubMed 21505900Geeraerts 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.
PubMed 18509619
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07540481
- Acronym / sponsor ID
- IJVC
- Conditions
- Intracranial Pressure, Ultrasonography
- Keywords
- Internal Jugular Vein, Catheterization, Ultrasonography, Optic Nerve Sheath Diameter, Intracranial Pressure, General Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients Undergoing Internal Jugular Vein Catheterization | – | Procedure: Internal Jugular Vein CatheterizationAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing surgical procedures under general anesthesia at a tertiary care hospital, in whom internal jugular vein catheterization is performed as part of routine clinical care.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal Jugular Vein CatheterizationInternal 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. | Procedure or surgery | Adult Patients Undergoing Internal Jugular Vein Catheterization |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 30019201Robba 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.
- Background: PubMed 21505900Dubourg 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.
- Background: PubMed 18509619Geeraerts 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policies and concerns regarding patient confidentiality and data privacy. Data may be available from the corresponding author upon reasonable request and with appropriate ethical approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure and Ultrasonography, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayça Sultan Şahin, Prof. Dr. (+905323100840, aycasultan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07540481, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.