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Набор скоро начнётся NCT07540481

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

Наблюдательное Intracranial Pressure Ultrasonography

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Internal Jugular Vein Catheterization.
Кому может быть актуально
Состояния в реестре: Intracranial Pressure, Ultrasonography. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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

Первичные конечные точки

  • Change in Optic Nerve Sheath Diameter (mm) Following Internal Jugular Vein Catheterization [Срок оценки: Baseline (immediately after endotracheal intubation) and 5 minutes after internal jugular vein catheterization]
Вторичные конечные точки (8)
  • Change in Internal Carotid Artery Peak Systolic Velocity (PSV) Following Internal Jugular Vein Catheterization [Срок оценки: 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 [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in Internal Carotid Artery Time-Averaged Maximum Velocity (TAMAX) Following Internal Jugular Vein Catheterization [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in Internal Carotid Artery Pulsatility Index (PI) Following Internal Jugular Vein Catheterization [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in Internal Carotid Artery Systolic/Diastolic Ratio (S/D) Following Internal Jugular Vein Catheterization [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in Mean Arterial Pressure (MAP) [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in Heart Rate [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]
  • Change in End-Tidal Carbon Dioxide (EtCO₂) [Срок оценки: Baseline and 5 minutes after internal jugular vein catheterization]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • University of Health Sciences Kanuni Sultan Suleyman Training and Research Hospital — Istanbul

Публикации

  • 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

Идентификаторы

NCT: NCT07540481 · IJVC

Первоисточники (государственные реестры)

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