Ultrasound Guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique

NCT05399108 | Completed

• 1 other identifier: UltrasoundLateralCannulation
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Central venous access is one of the most frequently used venous accesses in intensive care units. Insertion of the central venous catheter belongs to the basic skills of an intensivist. One of the veins that are available for catheterization is the internal jugular vein. It is recommended to perform jugular vein catheterization along with real-time ultrasound guidance. Imaging of the jugular vein is usually performed in two ways: on the short axis or on the long axis. The puncture method is described based on the type of needle imaging technique, out-of-plane or in-plane method. Traditionally, catheterization is performed by a medium approach during imaging the vein on a short axis using the out-of-plane technique. The main advantage of this procedure is proper imaging of the jugular vein and surrounding anatomical structures. However, the limited needle display is rather inconvenient, as only the needle tip can be displayed. This method of central venous catheterization has a first attempt success rate of 80%. This study is going to concentrate on discussing the performing of jugular vein catheterization by a novel lateral approach in-plane technique during imaging of the vein on the short axis. This procedure for placement of a central venous catheter into the internal jugular vein has not yet been described nor investigated. The above-mentioned method combines the advantage of reliable jugular vein imaging together with proper imaging of the whole needle. At the same time, the fixation of the catheter in the supraclavicular region allows for a better nursing routine, hence increasing the patient's comfort.

Conditions

Central Vein Catheter

Keywords

ultrasound guided catheterization; central vein catheterization; jugular vein catheterization; in-plane catheterization

Outcome Measures

Primary Outcomes (1)

• Success rate of first attempt

  Primary outcome is to prove that first attempt success rate by the novel approach is comparable with the success rate of the first attempt success rate of the conventional approach.

  Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.

Secondary Outcomes (3)

• Rate of complications

  Measured from the start of cannulation (local anesthetic infiltration) till extraction of the catheter, up to 45 days.

• Risk of neurological impairment assessed by Neurological Impairment Scale

  Measured from insertion the catheter till the extraction of the catheter, up to 45 days.

• Functional time of the catheter

  Measured from inserting the catheter till the extraction of the catheter, up to 45 days.

Study Arms (2)

The Novel Lateral Approach

EXPERIMENTAL

In this arm, the catheterization of the internal jugular vein is done with ultrasound guidance displaying the vein on its short axis using a lateral approach and in-plane technique. The catheterization is done according to the newest international recommendations for good clinical practice.

Procedure: Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein

The Conventional Approach

ACTIVE COMPARATOR

In this group catheterization of the jugular internal vein is done by conventional approach with ultrasound guidance using displaying on its short axis and using the out-of-plane technique.

Procedure: Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein

Interventions

Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein PROCEDURE

The jugular internal vein is displayed on its short axis. On the image are displayed the trapezius muscle and layers of skin. Just above the trapezius muscle using the in-plane technique is done puncture of the vein. By Seldinger's technique, catheterization is done. The whole procedure is done according to the newest international recommendations for central vein catheterization.

The Novel Lateral Approach

Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein PROCEDURE

The jugular internal vein is displayed on its short axis. The cannulation is done by the conventional approach (middle approach - the most frequently used).

The Conventional Approach

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years with an indication of central venous catheter placement

You may not qualify if:

• Not signing the informed consent
• BMI under 16,5
• Contraindication of central venous catheter placement into internal jugular vein (thrombosis, site infection, bleeding diseases, anticoagulation or antiaggregation therapy)
• hypersensitivity to sterile ultrasound gel
• neurological impairment on upper limbs
• neurodegenerative disorder

Sponsors & Collaborators

• Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.: lead

Study Sites (1)

Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.

Ústí nad Labem, Ústí Nad Labem Region, 40001, Czechia

Location

Study Officials

• Michal Kalina, MUDr.

  Krajská Zdravotní a.s. Masarykova Nemocnice v Ústí nad Labem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 1, 2022
• Study Start: July 25, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)