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OpenTrials
Completed

NCT Number: NCT04683302

3D Guided Internal Jugular Vein Catheterization

Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4.

For long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings.

Three dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce.

Recently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures.

The investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective cardiothoracic surgery with need for central venous catheter placement
  • written informed consent

Exclusion criteria

  • no informed consent
  • other site for central line placement (eg subclavian vein)
  • emergency surgery

Treatment and study plan

3DUS biplanar catheterization

Device

biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization

2D US catheterization

Device

2D short axis internal jugular vein catheterization

Primary outcomes

  1. first pass success

    Time frame: during procedure/surgery

    successful entry in internal jugular vein within one skin break and fluid motion

Secondary outcomes

  1. imaging time

    Time frame: during procedure/surgery

    time from placing USprobe until start needling (in seconds)

  2. needling time

    Time frame: during procedure/surgery

    time from puncturing skin until access in vein (in seconds)

  3. number of skin punctures

    Time frame: during procedure/surgery

    total skin breaks needed before successful entry in vein

  4. number of needle withdrawals

    Time frame: during procedure/surgery

    redirections of needle >5mm without needing new skin breaks

  5. number of posterior wall punctures

    Time frame: during procedure/surgery

    puncture of posterior wall of jugular vein

  6. operator satisfaction

    Time frame: procedure/surgery

    satisfaction of operator with visual feedback from US, rated on Likert Scale 1-5 with 1 no satisfaction at all and 5 totally satisfied

  7. needle visibility

    Time frame: procedure/surgery

    visualization of needle during procedure on US screen, rating from good - adequate - poor

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Eindhoven University of Technology

Registry information

Official study title

3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients

Acronym: 3D Givenchy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2020
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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