CClinicalTrials.gg
Status unknownNCT05409768Updated Feb 15, 2023

Comparison of Two Approach in Ultrasound Guided Central Venous Catheterizations

An interventional study of Short axis out of plane and Anteroposterior short axis in plane in Central Venous Catheterization, sponsored by Abant Izzet Baysal University. Status unknown at 2 sites in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Central Venous Catheterization

Keywords

  • Ultrasound Guided Short
  • Central Venous Catheterization
  • Short Axis in-plane
03

In context

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 242 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients that are planned a central venous catheter placement

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Short axis, out of plane approach

    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

  • Experimental
    Short axis, anteroposterior in plane approach

    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

  • ProcedureShort 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.

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

  • ProcedureAnteroposterior 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.

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

06

What researchers measure

Primary outcomes

  1. Number of puncture attempts

    Number of needle insertions to the catheterization region for placing a catheter

    Time frame: From the 1st second through withdrawal of the needle, up to 3 minutes

  2. Cannulation procedural time

    Duration of the whole cannulation procedure

    Time frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes

  3. Catheterization procedural time

    Duration of the whole catheterization procedure

    Time frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes

  4. Number of needle redirections

    Redirections of the needle towards the vessel

    Time frame: During the whole cannulation procedure

  5. Success rate

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

    Time frame: Through catheterizations completion, an average of 4 months

  6. Success rate at first attempt

    Success rate at first attempt of the procedures in each group

    Time frame: Through study completion, an average of 4 months

  7. Complications

    Rate of complications that occur during catheterization procedure

    Time frame: Through study completion, an average of 4 months ]

Secondary outcomes

  1. Vessel visualization

    Visualization of the vessels in dynamic ultrasound images

    Time frame: Throughout the procedure; up to 3 minutes

  2. Needle visualization

    Visualization of the needle in dynamic ultrasound images

    Time frame: Throughout the procedure; up to 3 minutes

  3. Guide-wire visualization

    Visualization of the guide-wire in dynamic ultrasound images

    Time frame: Throughout the procedure; up to 3 minute

  4. 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

    Time frame: Throughout the procedure; up to 3 minutes

  5. Ultrasound time

    The duration of pre-procedural ultrasound scanning

    Time frame: Throughout the pre-procedural ultrasonography; up to 10 minutes

07

Study locations

1 of 2 sites recruiting
  • Abant İzzet Baysal Education and Training Hospital
    Bolu, Merkez, Turkey
    Recruiting
  • Bolu Abant İzzet Baysal University Faculty of Medicine
    Bolu, 14030, Turkey
    Completed
08

References and documents

Publications

  • 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. PubMed 31635927 ↗
  • 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. PubMed 29478705 ↗
  • 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. PubMed 34247928 ↗
  • 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. PubMed 24101418 ↗
  • 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. PubMed 22127816 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05409768
Lead sponsor
Abant Izzet Baysal University
Responsible party
Ilker Ital (Assistant Professor Doctor, Abant Izzet Baysal University) — Principal investigator
First posted
Jun 8, 2022
Start date
Aug 1, 2022
Primary completion
Sep 10, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Feb 15, 2023

Study contacts

Ilker Ital, MD
Contact
ilkerital@gmail.com
(0374) 253 46 56
Murat Bilgi, MD
Contact
drmuratbilgi@gmail.com
(0374) 253 46 56
Ilker Ital, MD
principal investigator · Bolu Abant Izzet Baysal University Medical School

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion