Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization

Central Venous Catheter Placement Clinical Trial

Official title:

Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization: Jugular Venous Catheterization With Oblique Approach and Brachiocephalic Catheterization Using Y-shape Image

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04256564
• Other study ID #: 2019/06OBLVSYSHAPE
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Kutahya Medical Sciences University
• Contact: Onur Balaban, MD..
• Phone: +90 274 231 6660
• Email: obalabandr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Eighty patients are planned to include in this study. Patients will be assigned to two groups: Oblique visualization Group (central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique) and Y-shape visualization Group (central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique). Two groups will be compared in terms of number of puncture attempts, procedural time, time of preprocedural ultrasound scanning, overall success rate, complications, the ease of the catheterization process and ultrasound visibility.

Description:

Central venous catheters are frequently placed in the operating rooms, intensive care units and emergency departments for various indications such as intravenous fluid, drug infusion, measurement of cardiac parameters and lack of vascular access. Ultrasound guidance has become a standard for central venous catheterization. The use of ultrasound has reduced the number of puncture attempts, increased success rate and reduced complications. While the central venous catheter is inserted by ultrasound, the vessels and the needle can be imaged in real-time. In plane and out-of-plane imaging techniques can be used during catheterization. The in-plane technique ensures the entire needle visualization in ultrasound images. With the linear ultrasound probe, the vessel and needle are imaged longitudinally in the in-plane technique. When an endocavity (micro-convex) ultrasound probe is used, three central vessels (jugular, subclavian and brachiocephalic veins) are displayed as Y-shape. The advantage of the endocavity (micro-convex) probe is that it can visualize deeper tissues and deep veins, and more tissues can be imaged in wider angle. Both techniques have been successfully applied in central catheter placement. In-plane technique also ensures syringe-free cannulation where blood aspiration with a syringe attached to the needle is not necessary.

The aim of this study is to compare two different ultrasound guided in-plane techniques for central venous catheterization. The investigators planned to compare jugular venous catheterization using a linear probe and lateral oblique approach to brachiocephalic catheterization using a micro-convex probe and Y-shape imaging.

The primary outcomes are number of puncture attempts, success rate at first attempt, overall success rate, procedure time, ultrasound scanning time and rate of complications. Secondary outcomes are visibility of the veins and the needle in ultrasound images.

The trial is a comparison of two different interventional technique and planned as prospective randomized and single-blind study. Patients aged between 18-85 years that are planned central venous catheter placement will be included in the study. Patients included in the study will be assigned into two groups by computer-assisted randomization. In the first group (Oblique visualization Group), central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique. In the second group (Y-shape visualization Group), central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique Linear ultrasound probe will be used in the first group, and endocavity (micro-convex) ultrasound probe will be used in the second group.

In both groups, the number of puncture attempts, the number of needle redirections, and the procedure time will be recorded. The time of preprocedural ultrasound scanning will be recorded in both groups. In addition, complications during the procedure such as bleeding, hemothorax, pneumothorax, hematoma and carotid vascular injury will be recorded. Overall success rates will be assessed in each group at the end of the study. A catheterization procedure will be considered as "unsuccessful" after third puncture attempt or more than 10 needle redirections are needed or requires a procedure time more than 3 minutes. At this moment, the catheter will be placed to a different region or the investigators will switch to a different approach. The ease of the catheterization process will be scored between 0 and 10 by the investigator performing the process (0: the hardest, 10: the easiest). The ultrasound visibility of the needle, vessels, guide wire and catheter will be scored between 0 and 4 (4: excellent view, 3: good view, 2: Medium, 1: difficult 0: impossible to image). The recorded data will be compared between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients that are planned a central venous catheter placement

Exclusion Criteria:

• Morbid obese patients (body mass index> 40)

• People with severe coagulopathy

• Severe deformity at the neck

• Skin deformity or infection at catheterization site

• Congenital anomalies of central veins

Related Conditions & MeSH terms

• Central Venous Catheter Placement

Intervention

Procedure:
• Central venous catheterization
A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University, Evliya CelebiHospital	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Medical Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Baidya DK, Chandralekha, Darlong V, Pandey R, Goswami D, Maitra S. Comparative Sonoanatomy of Classic "Short Axis" Probe Position with a Novel "Medial-oblique" Probe Position for Ultrasound-guided Internal Jugular Vein Cannulation: A Crossover Study. J Emerg Med. 2015 May;48(5):590-6. doi: 10.1016/j.jemermed.2014.07.062. Epub 2015 Jan 24. — View Citation

Ince I, Ari MA, Sulak MM, Aksoy M. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance]. Rev Bras Anestesiol. 2018 May - Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23. Portuguese. — View Citation

Ital I, Balaban O, Aydin T. Old probe, new method: Y-shape visualization of central veins using endocavitary transducer via omoclavicular acoustic window. Am J Emerg Med. 2018 Mar;36(3):511-513. doi: 10.1016/j.ajem.2017.07.096. Epub 2017 Jul 31. — View Citation

Kim SC, Heinze I, Schmiedel A, Baumgarten G, Knuefermann P, Hoeft A, Weber S. Ultrasound confirmation of central venous catheter position via a right supraclavicular fossa view using a microconvex probe: an observational pilot study. Eur J Anaesthesiol. 2015 Jan;32(1):29-36. doi: 10.1097/EJA.0000000000000042. — View Citation

Mallin M, Louis H, Madsen T. A novel technique for ultrasound-guided supraclavicular subclavian cannulation. Am J Emerg Med. 2010 Oct;28(8):966-9. doi: 10.1016/j.ajem.2009.07.019. Epub 2010 Jan 28. — View Citation

Matias F, Semedo E, Carreira C, Pereira P. [Ultrasound-guided central venous catheterization - "Syringe-Free" approach]. Rev Bras Anestesiol. 2017 May - Jun;67(3):314-317. doi: 10.1016/j.bjan.2016.08.005. Epub 2016 Sep 17. Portuguese. — View Citation

Schmidt GA, Maizel J, Slama M. Ultrasound-guided central venous access: what's new? Intensive Care Med. 2015 Apr;41(4):705-7. doi: 10.1007/s00134-014-3628-6. Epub 2015 Jan 8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of puncture attempts	Number of needle insertions to the catheterization region for placing a catheter	During the whole cannulation procedure, starting from the 1st minute until the end of the procedure
Primary	Cannulation procedural time	Duration of the whole cannulation procedure	From the 1st minute through withdrawal of the needle, up to 3 minutes
Primary	Catheterization procedural time	Duration of the whole catheterization procedure	During the procedure, starting from the 1st minute through placement of the catheter; up to 3 minutes
Primary	Number of needle redirections	Redirections of the needle towards the vessel	During the whole cannulation procedure, starting from the 1st minute through the procedure; assessed up to 3 minutes
Primary	Success rate	Overall success rates of the procedures in each group	Through study completion, an average of 4 months
Primary	Success rate at first attempt	Success rate at first attempt of the procedures in each group	Through study completion, an average of 4 months
Primary	Complications	Rate of complications that occur during catheterization procedure	Through study completion, an average of 4 months
Secondary	Vessel visualization	Visualization of the vessels in dynamic ultrasound images	Throughout the procedure; up to 3 minutes
Secondary	Needle visualization	Visualization of the needle in dynamic ultrasound images	Throughout the procedure; up to 3 minutes
Secondary	Guide-wire visualization	Visualization of the guide-wire in dynamic ultrasound images	Throughout the procedure; up to 3 minutes
Secondary	Catheter visualization	Visualization of the catheter in dynamic ultrasound images	At the end of catheterization procedure
Secondary	Ease of the catheterization process	A subjective score assigned by the operator on a scale with a minimum value of 0 and maximum value of 10. Higher scores mean a better outcome.	Throughout the procedure; up to 3 minutes
Secondary	Ultrasound time	The duration of pre-procedural ultrasound scanning	Throughout the pre-procedural ultrasonography; up to 10 minutes