- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07773506
Ultrasound Assessment of Internal Jugular Vein for Cannulation and Venous Pressure Prediction
Ultrasound Guidance for Internal Jugular Vein Cannulation: Can Doppler Ultrasound Predict Jugular Venous Pressure Changes by Assessment of Internal Jugular Vein Diameter and Collapsibility?
This prospective observational study aims to evaluate the diagnostic utility of vascular ultrasound for internal jugular vein (IJV) assessment in adult patients undergoing clinically indicated IJV cannulation.
Traditionally, bedside clinical assessment of jugular venous pressure (JVP) is challenging and frequently imprecise in critically ill or obese individuals. This study investigates whether non-invasive ultrasound parameters, specifically IJV diameter, collapsibility index, and Doppler flow patterns, can reliably estimate central venous pressure (CVP) and identify elevated JVP.
Participants admitted to the Intensive Care Unit, Emergency Department, or Operating Theatres who require right IJV catheterization will receive a standardized pre-procedural vascular ultrasound evaluation in a supine position (0-30° head elevation) prior to routine, ultrasound-guided cannulation. Ultrasound measurements will then be compared to direct central venous pressure readings to assess diagnostic accuracy and correlation.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients admitted to the Intensive Care Unit (ICU), Emergency Department, or Operating Theatres who require internal jugular vein (IJV) cannulation for clinical indications.
- Patients in whom ultrasound-guided right internal jugular vein cannulation is planned.
- Patients who are hemodynamically stable enough to undergo ultrasound examination before cannulation.
- Patients able to undergo vascular ultrasound examination in the supine position (0-30° head elevation according to the study protocol).
- Patients in whom complete ultrasound assessment of the internal jugular vein can be performed (including maximum diameter, minimum diameter, cross-sectional area, and collapsibility/distensibility index).
- Patients with a clinically indicated assessment of central venous pressure (CVP) or jugular venous pressure (JVP) allowing comparison with ultrasound measurements.
- Patients providing written informed consent, or consent obtained from a legally authorized representative when applicable.
Exclusion Criteria:
- Patients younger than 18 years of age.
- Previous surgery, radiotherapy, or significant trauma involving the neck.
- Known thrombosis, stenosis, or congenital anomalies of the internal jugular vein.
- Local infection, cellulitis, burn, or hematoma at the intended cannulation site.
- Large neck masses, thyroid enlargement, or cervical pathology causing distortion of neck anatomy.
- Severe coagulopathy or uncontrolled bleeding disorders contraindicating internal jugular vein cannulation.
- Patients with cervical spine instability or those in whom proper positioning for ultrasound examination is not possible.
- Inadequate ultrasound visualization of the internal jugular vein.
- Severe tricuspid valve disease or conditions causing marked alterations in central venous hemodynamics that interfere with accurate interpretation of IJV measurements.
- Refusal of the patient or legally authorized representative to provide informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Ultrasound-Guided IJV Cannulation Cohort
Adult patients in the Intensive Care Unit, Emergency Department, or Operating Theatres requiring ultrasound-guided right internal jugular vein (IJV) cannulation for clinical indications.
Participants undergo pre-procedural vascular ultrasound to assess IJV diameter, collapsibility index, and Doppler flow characteristics in the supine position (0-30° head elevation), followed by ultrasound-guided catheterization and comparison with central venous pressure measurements.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Internal Jugular Vein Collapsibility Index Percentage
Časové okno: Baseline
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The Internal Jugular Vein (IJV) collapsibility index is evaluated by bedside vascular ultrasound and calculated using the formula: [(maximum anterior-posterior diameter during expiration - minimum anterior-posterior diameter during inspiration) / maximum anterior-posterior diameter during expiration] * 100.
The outcome is reported as a continuous percentage from 0% to 100%, where higher values indicate greater vein collapsibility
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Baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- US-Guided IJV Access and JVP
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