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3D Guided Internal Jugular Vein Catheterization (3D Givenchy)

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ClinicalTrials.gov Identifier: NCT04683302
Recruitment Status : Completed
First Posted : December 24, 2020
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
Eindhoven University of Technology
Information provided by (Responsible Party):
Harm Scholten, Catharina Ziekenhuis Eindhoven

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Catheter Related Complication Ultrasound; Complications Device: 3DUS biplanar catheterization Device: 2D US catheterization Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial (RCT)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: coded (e)crf's and anonymized and coded ultrasound clips
Primary Purpose: Prevention
Official Title: 3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients
Actual Study Start Date : March 15, 2021
Actual Primary Completion Date : August 15, 2021
Actual Study Completion Date : September 15, 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: control
conventional 2D guided internal jugular vein catheterization
 Device: 2D US catheterization
2D short axis internal jugular vein catheterization
Experimental: intervention
3D biplanar guided internal jugular vein catheterization
 Device: 3DUS biplanar catheterization
biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization


Outcome Measures
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Primary Outcome Measures :
  1. first pass success [ Time Frame: during procedure/surgery ]
    successful entry in internal jugular vein within one skin break and fluid motion


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683302


Locations
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Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Eindhoven University of Technology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Harm Scholten, MD, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT04683302    
Other Study ID Numbers: 3DJUG
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Harm Scholten, Catharina Ziekenhuis Eindhoven:
ultrasound
internal jugular vein
cardiothoracic surgery