NCT07540481

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Mar 2027

First Submitted

Initial submission to the registry

March 26, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2027

Last Updated

April 20, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 26, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Internal Jugular VeinCatheterizationUltrasonographyOptic Nerve Sheath DiameterIntracranial PressureGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    Baseline and 5 minutes after internal jugular vein catheterization

  • Change in Internal Carotid Artery Time-Averaged Maximum Velocity (TAMAX) Following Internal Jugular Vein Catheterization

    Baseline and 5 minutes after internal jugular vein catheterization

  • Change in Internal Carotid Artery Pulsatility Index (PI) Following Internal Jugular Vein Catheterization

    Baseline and 5 minutes after internal jugular vein catheterization

  • Change in Internal Carotid Artery Systolic/Diastolic Ratio (S/D) Following Internal Jugular Vein Catheterization

    Baseline and 5 minutes after internal jugular vein catheterization

  • +3 more secondary outcomes

Study Arms (1)

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.

Procedure: Internal Jugular Vein Catheterization

Interventions

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.

Adult Patients Undergoing Internal Jugular Vein Catheterization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 30019201BACKGROUND
  • 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: 21505900BACKGROUND
  • 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: 18509619BACKGROUND

Central Study Contacts

Ayça Sultan Şahin, Prof. Dr.

CONTACT

Aysun Edehan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 20, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 16, 2027

Last Updated

April 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations