Comparison of Two Approach in Ultrasound Guided Central Venous Catheterizations

NCT05409768 | Unknown DMC

• 1 other identifier: AIBU-TF-AR-II-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Central Venous Catheterization

Keywords

Ultrasound Guided Short; Central Venous Catheterization; Short Axis in-plane

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• Number of needle redirections

  Redirections of the needle towards the vessel

  During the whole cannulation procedure

• Success rate

  Correct placement of the catheter over the guidewire after central vein puncture

  Through catheterizations completion, an average of 4 months

• Success rate at first attempt

  Success rate at first attempt of the procedures in each group

  Through study completion, an average of 4 months

• Complications

  Rate of complications that occur during catheterization procedure

  Through study completion, an average of 4 months ]

Secondary Outcomes (5)

• Vessel visualization

  Throughout the procedure; up to 3 minutes

• Needle visualization

  Throughout the procedure; up to 3 minutes

• Guide-wire visualization

  Throughout the procedure; up to 3 minute

• Ease of the catheterization process

  Throughout the procedure; up to 3 minutes

• Ultrasound time

  Throughout the pre-procedural ultrasonography; up to 10 minutes

Study Arms (2)

Short axis, out of plane approach

EXPERIMENTAL

A linear ultrasound probe will be utilized to place the central catheter into the jugular vein with a short axis out of the plane method

Procedure: Short axis out of plane

Short axis, anteroposterior in plane approach

EXPERIMENTAL

A linear ultrasound probe will be utilized to place the central catheter into the jugular vein with an anteroposterior short axis in-plane method

Procedure: Anteroposterior short axis in plane

Interventions

Short axis out of plane PROCEDURE

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.

Also known as: Ultrasound guided central venous catheterization with short axis out of plane approach

Short axis, out of plane approach

Anteroposterior short axis in plane PROCEDURE

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.

Also known as: Ultrasound guided central venous catheterization with anteroposterior short axis in plane approach

Short axis, anteroposterior in plane approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that are planned a central venous catheter placement

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Abant İzzet Baysal Education and Training Hospital

Bolu, Merkez, Turkey (Türkiye)

RECRUITING

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, 14030, Turkey (Türkiye)

COMPLETED

Related 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.

  PMID: 31635927 BACKGROUND

• 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.

  PMID: 29478705 BACKGROUND

• 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.

  PMID: 34247928 BACKGROUND

• 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.

  PMID: 24101418 BACKGROUND

• 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.

  PMID: 22127816 BACKGROUND

MeSH Terms

Interventions

Aircraft

Intervention Hierarchy (Ancestors)

Aviation; Transportation; Technology, Industry, and Agriculture

Study Officials

• Ilker Ital, MD

  Bolu Abant Izzet Baysal University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilker Ital, MD

CONTACT

(0374) 253 46 56; ilkerital@gmail.com

Murat Bilgi, MD

CONTACT

(0374) 253 46 56; drmuratbilgi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: June 8, 2022
• Study Start: August 1, 2022
• Primary Completion: September 10, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

TU (2)