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

NCT04256564 | Unknown

• 1 other identifier: 2019/06OBLVSYSHAPE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Catheter Placement

Keywords

Central venous catheter; Ultrasound; Jugular vein; Brachiocephalic vein; Endocavity micro-convex probe; Y-Shape

Outcome Measures

Primary Outcomes (7)

• 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

• Cannulation procedural time

  Duration of the whole cannulation procedure

  From the 1st minute through withdrawal of the needle, up to 3 minutes

• 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

• 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

• Success rate

  Overall success rates of the procedures in each group

  Through study 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 (6)

• 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 minutes

• Catheter visualization

  At the end of catheterization procedure

• Ease of the catheterization process

  Throughout the procedure; up to 3 minutes

Study Arms (2)

Oblique visualization linear probe

EXPERIMENTAL

A linear ultrasound probe will be utilized to place the central catheter into the jugular vein

Procedure: Central venous catheterization

Y-shape visualization micro-convex probe

EXPERIMENTAL

A micro-convex endocavity ultrasound probe will be utilized to place the central catheter into the brachiocephalic vein

Procedure: Central venous catheterization

Interventions

Central venous catheterization 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

Oblique visualization linear probe; Y-shape visualization micro-convex probe

Eligibility Criteria

• Age: 19 Years - 85 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University, Evliya CelebiHospital

Kütahya, 43040, Turkey (Türkiye)

Location

Related Publications (7)

• 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. No abstract available.

  PMID: 25567384 BACKGROUND

• 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.

  PMID: 25630474 BACKGROUND

• 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.

  PMID: 20887917 BACKGROUND

• 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. No abstract available.

  PMID: 28789889 BACKGROUND

• 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.

  PMID: 24384583 BACKGROUND

• 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.

  PMID: 27650385 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

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Onur Balaban, MD.

  Kutahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Onur Balaban, MD..

CONTACT

+90 274 231 6660; obalabandr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will not be aware of the catheterization technique used.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: There will be two parallel groups in each a different central catheterization method will be performed.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TU (1)