Comparison of Two Approach in Ultrasound Guided Central Venous Catheterizations

Central Venous Catheterization Clinical Trial

Official title:

Comparison of Short Axis Out of Plane Method and Anteroposterior Short Axis in Plane Method in Ultrasound-guided Central Venous Catheterizations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409768
• Other study ID #: AIBU-TF-AR-II-001
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Abant Izzet Baysal University
• Contact: Ilker Ital, MD
• Phone: (0374) 253 46 56
• Email: ilkerital[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ultrasound guidance in central venous catheterization has become the standard for clinical practice. Many approaches have been described in ultrasound guided catheterization procedures. The aim of this study is to compare the classical short axis out of plane (SAX-OOP) approach and the new anteroposterior short axis in plane (APSAX-IP approach in central jugular venous catheterization. The study was planned as prospective randomized and controlled. One hundred patients were planned to be included in this study.

Patients will be divided into two groups: Central jugular vein catheterization will be performed with the short axis out of plane group (ultrasound transducer will be positioned classically from medial to lateral in the neck) and anteroposterior short axis in plane group (ultrasound transducer will be positioned laterally from anterior to posterior on the neck). The two groups will be compared in terms of number of puncture attempts, duration of the procedure, ultrasound scan time before the procedure, number of needle redirection, overall success rate, complications, ease of catheterization and ultrasound visibility.

Description:

Central venous catheterization is a method frequently used in intensive care patients and patients to be operated. With classical methods, this central venous vascular access procedure in the landmark method can be performed or it can be successfully performed under ultrasound guidance.

Ultrasound-guided central venous catheterization is a safer and recommended approach. During venous catheterization with ultrasound the vein and its neighborhood can be easily visualized and it can be followed while the needle is directed to the target in vein puncture. Undesirable complications (hematoma, pneumothorax, arterial puncture) also decrease with the decrease in the number of punctures under ultrasound guidance. Ultrasound guided central catheterization which facilitates safer and faster procedures constitutes an important area for patient care. With the development of technology and the increase in accessibility it constitutes an important and useful area in the interventions made with ultrasound. The internal jugular vein is a frequently chosen central venous structure.

Many ultrasound-guided imaging and intervention methods have been described for catheterization of the internal jugular vein with the Seldinger method. These are described as longitudinal (long axis), transverse (short axis) and oblique methods for imaging and probe position. The image taken with the position of the needle relative to the ultrasound probe is described as in plane and out of plane.

Each method may have advantages over each other and can be preferred according to the patient's condition and the experience of the practitioner. Successful and safe catheterizations can be performed in the internal jugular vein with the short axis out-of-plane (SAX-OOP) method which is especially used in adults . Short axis out of plane is a successful method that can almost be called a classic that comes to mind first. Compared to other needle imaging methods out of plane tracking of the needle (as a point) seems to be a disadvantage in the user's imaging compared to the in-plane tracking method. Of course, it is easier and faster to capture the short axis when imaging the venous structure as long axis or short axis with ultrasound.

The " Anteroposterior short axis in plane" (APSAX-IP) technique is first reported by Aithal G. et al. in 2019. The use of both short axis and in-plane approaches has been described.The difference of the anteroposterior short axis in plane (APSAX-IP ) technique from the classical short axis out of plane (SAX-OOP) technique is that the location of the ultrasound is lateral to the neck, the needle is about 2-3 cm away from the ultrasound, the entry area from the skin, the needle is advanced subcutaneously in the anteroposterior direction, not medially, and the needle is not as a point in ultrasound that can be viewed longitudinally. It is thought that the APSAX-IP method has advantages such as easier follow-up of the needle, easier monitoring of the progression of the needle without damaging the posterior wall by seeing a large anterior posterior diameter of the vessel. It is stated that the APSAX-IP method will be more ergonomic in patients with short neck anatomy, obese and pediatric patients due to the location of the ultrasound probe. One method may be preferred over the other in patients. Although the definition of the method has been made, it has not been compared with any catheterization method. The aim of our study is to compare the classical SAX-OOP method and the newly defined APSAX-IP method in terms of difficulty, needle puncture time, needle procedure time and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 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

• Emergency operations

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

Procedure:
• Short axis out of plane
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 short axis visualisation out of plane approaches.
• Anteroposterior short axis in plane
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 anteroposterior short axis visualisation in plane approaches.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal Education and Training Hospital	Bolu	Merkez
Turkey	Bolu Abant Izzet Baysal University Faculty of Medicine	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Aithal G, Muthuswamy G, Latif Z, Bhaskaran V, Haji Sani HS, Shindhe S, Manap NBA, Vadaje KS, Dato Paduka Buntar WS, Daiwajna RG. An Alternate In-Plane Technique of Ultrasound-Guided Internal Jugular Vein Cannulation. J Emerg Med. 2019 Dec;57(6):852-858. doi: 10.1016/j.jemermed.2019.08.029. Epub 2019 Oct 18. — View Citation

Aydin T, Balaban O, Turgut M, Tokur ME, Musmul A. A Novel Method for Ultrasound-Guided Central Catheter Placement-Supraclavicular Brachiocephalic Vein Catheterization Versus Jugular Catheterization: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2022 Apr;36(4):998-1006. doi: 10.1053/j.jvca.2021.06.010. Epub 2021 Jun 12. — 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]. Braz J Anesthesiol. 2018 May-Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23. — View Citation

Rossi UG, Rigamonti P, Ticha V, Zoffoli E, Giordano A, Gallieni M, Cariati M. Percutaneous ultrasound-guided central venous catheters: the lateral in-plane technique for internal jugular vein access. J Vasc Access. 2014 Jan-Feb;15(1):56-60. doi: 10.5301/jva.5000177. Epub 2013 Oct 7. — View Citation

Troianos CA, Hartman GS, Glas KE, Skubas NJ, Eberhardt RT, Walker JD, Reeves ST; Councils on Intraoperative Echocardiography and Vascular Ultrasound of the American Society of Echocardiography; Society of Cardiovascular Anesthesiologists. Special articles: guidelines for performing ultrasound guided vascular cannulation: recommendations of the American Society of Echocardiography and the Society Of Cardiovascular Anesthesiologists. Anesth Analg. 2012 Jan;114(1):46-72. doi: 10.1213/ANE.0b013e3182407cd8. Epub 2011 Nov 29. No abstract available. — 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	From the 1st second through withdrawal of the needle, up to 3 minutes
Primary	Cannulation procedural time	Duration of the whole cannulation procedure	During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes
Primary	Catheterization procedural time	Duration of the whole catheterization procedure	During the procedure, starting from the 1st second 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
Primary	Success rate	Correct placement of the catheter over the guidewire after central vein puncture	Through catheterizations 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 minute
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