- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07691554
Comparison of Short-Axis and Long-Axis Internal Jugular Vein Cannulation for First-Pass Success
Comparison Between Short Axis and Long Axis For Cannulation Of Internal Jugular Vein in Terms Of First Pass Success
Přehled studie
Postavení
Podmínky
Detailní popis
This randomized controlled trial aims to compare the effectiveness of short-axis and long-axis ultrasound-guided approaches for cannulation of the internal jugular vein (IJV) in terms of first-pass success. Central venous catheterization is a commonly performed procedure for invasive monitoring and administration of medications and fluids. Ultrasound guidance has improved the safety and success of IJV cannulation compared with traditional landmark-based techniques; however, uncertainty remains regarding the optimal ultrasound imaging approach.
A total of 60 eligible patients undergoing IJV cannulation will be enrolled and randomly allocated into two equal groups. Participants in Group A will undergo ultrasound-guided IJV cannulation using the short-axis approach, while participants in Group B will undergo cannulation using the long-axis approach. All procedures will be performed by the researcher under direct supervision using standardized ultrasound-guided techniques.
The primary objective is to compare the frequency of first-pass success between the two approaches. First-pass success is defined as successful IJV cannulation with a single skin puncture and without needle redirection. Baseline demographic and clinical characteristics will be recorded before the procedure. The findings of this study may help identify the preferred ultrasound-guided technique for maximizing first-pass success during IJV cannulation and potentially reducing procedure-related complications associated with multiple cannulation attempts.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Waleed Noor, MBBS FCPS
- Telefonní číslo: +923154960902
- E-mail: mrwaleed2394@gmail.com
Studijní záloha kontaktů
- Jméno: Shahida Khawaja, MBBS FCPS
- Telefonní číslo: +92 300 8462091
- E-mail: khawaja.shahida@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- National Hospital and Medical Center
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Kontakt:
- National Hospital and Medical Center
- Telefonní číslo: +9242 111 17 18 19
- E-mail: info@nationalhospital.org
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age 25-70 years.
- Either male or female gender.
- Undergoing cannulation of IJV.
Exclusion Criteria:
- Patients who will be on hemodialysis therapy through double lumen catheter in IJV, assessed by reviewing previous medical records.
- Patients who will have history of previous insertion of IJV line, assessed by reviewing previous medical records.
- Patients with history of neck surgery, assessed by reviewing previous medical records.
- Uncooperative patient.
- Platelet count < 50,000/mm3.
- International normalized ration 3 times upper normal limit (1.1).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Group A (Short-Axis Approach)
In this approach, IJV will be visualized by placing the transducer in a transverse orientation on the patient neck at the level of the cricoid cartilage.
The needle will be inserted at 60° to the vertical and will be advanced toward the vein employing gentle aspiration on the attached syringe.
Entry to the vein will be confirmed by visualizing indentation of the anterior wall of the vein followed by blood in the syringe and by visualizing the tip of the needle inside the vein.
Guide wire will be passed followed by dilator insertion and finally central vein line.
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Internal jugular vein cannulation performed under ultrasound guidance using the short-axis approach.
The transducer is placed in a transverse orientation at the level of the cricoid cartilage, allowing visualization of the internal jugular vein and carotid artery during needle insertion.
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Aktivní komparátor: Group B (Long-Axis Approach)
In this approach, the probe will be centered on the IJV and rotated through 90° in a clockwise direction resulting in long axis image of the vein.
The needle insertion point will be directly beneath the most proximal end of the ultrasound probe.
The needle will be inserted at 30° to the vertical and will be advanced toward the vein employing gentle aspiration.
Entry to the vein will be confirmed by visualizing needle entry into the vein followed by aspiration of blood in the syringe.
Guide wire will be inserted followed by dilator insertion and finally central vein line.
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Internal jugular vein cannulation performed under ultrasound guidance using the long-axis approach.
The transducer is rotated to obtain a longitudinal view of the internal jugular vein, allowing continuous visualization of the needle during vessel cannulation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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First-Pass Success Rate of Ultrasound-Guided Internal Jugular Vein Cannulation
Časové okno: Assessed during the cannulation procedure (within 5 minutes of initiation of cannulation).
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First-pass success rate of ultrasound-guided internal jugular vein cannulation, defined as successful venous cannulation with a single skin puncture and needle pass.
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Assessed during the cannulation procedure (within 5 minutes of initiation of cannulation).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total Cannulation Success Rate
Časové okno: Assessed during the procedure (within 15 minutes).
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Total cannulation success rate, defined as successful placement of the internal jugular venous catheter.
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Assessed during the procedure (within 15 minutes).
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Number of Needle Passes Required for Successful Cannulation
Časové okno: Recorded during the procedure.
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Total number of needle insertion attempts required to achieve successful ultrasound-guided internal jugular vein cannulation.
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Recorded during the procedure.
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Incidence of Hematoma Formation at the Cannulation Site
Časové okno: Assessed immediately after the procedure and within 24 hours.
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Occurrence of hematoma at the internal jugular vein cannulation site following ultrasound-guided catheter insertion.
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Assessed immediately after the procedure and within 24 hours.
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Incidence of Posterior Vessel Wall Puncture
Časové okno: Assessed during the procedure.
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Occurrence of unintended puncture of the posterior wall of the internal jugular vein during ultrasound-guided cannulation.
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Assessed during the procedure.
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Incidence of Pneumothorax Following Cannulation
Časové okno: Assessed within 24 hours following cannulation.
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Occurrence of pneumothorax associated with ultrasound-guided internal jugular vein cannulation.
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Assessed within 24 hours following cannulation.
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Overall Procedure-Related Complications
Časové okno: Assessed during the procedure and up to 24 hours after cannulation.
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Frequency of procedure-related adverse events, including hematoma, posterior vessel wall puncture, pneumothorax, or other complications occurring during or after ultrasound-guided internal jugular vein cannulation.
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Assessed during the procedure and up to 24 hours after cannulation.
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Shahida Khawaja, MBBS, FCPS, National Hospital and Medical Center
Publikace a užitečné odkazy
Obecné publikace
- Shrestha GS, Gurung A, Koirala S. Comparison between long- and short-axis techniques for ultrasound-guided cannulation of internal jugular vein. Ann Card Anaesth. 2016 Apr-Jun;19(2):288-92. doi: 10.4103/0971-9784.179629.
- Rath A, Mishra SB, Pati B, Dhar SK, Ipsita S, Samal S, Azim A. Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial. Am J Emerg Med. 2020 Apr;38(4):731-734. doi: 10.1016/j.ajem.2019.06.010. Epub 2019 Jun 14.
- Tolson OW. Should central venous pressure be used to guide critical care management? Br J Hosp Med (Lond). 2022 Oct 2;83(10):1-3. doi: 10.12968/hmed.2022.0167. Epub 2022 Oct 11.
Užitečné odkazy
- Should central venous pressure be used to guide critical care management?
- Central venous catheterization in cancer patients with severe thrombocytopenia: Ultrasound-guide improves safety avoiding prophylactic platelet transfusion
- Short versus long axis ultrasound guided approach for internal jugular vein cannulations: A prospective randomized controlled trial
- Comparing 1st Pass Success Rate and Number of Attempts for Internal Jugular Vein Cannulation by USG Guided Approach: Short Axis versus Long Axis Technique
- A Comparative Study of Internal Jugular Vein Cannulation under Ultrasound Guidance Using Short Axis or Long Axis View Approach
- Comparison between long- and short-axis techniques for ultrasound-guided cannulation of internal jugular vein
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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