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3D Guided Internal Jugular Vein Catheterization

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04683302
Acronym
3D Givenchy
Enrollment
126
Registered
2020-12-24
Start date
2021-03-15
Completion date
2021-09-15
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Complication, Ultrasound; Complications

Keywords

ultrasound, internal jugular vein, cardiothoracic surgery

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

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.

Interventions

DEVICE3DUS 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

DEVICE2D US catheterization

2D short axis internal jugular vein catheterization

Sponsors

Eindhoven University of Technology
CollaboratorOTHER
Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

coded (e)crf's and anonymized and coded ultrasound clips

Intervention model description

randomized clinical trial (RCT)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
first pass successduring procedure/surgerysuccessful entry in internal jugular vein within one skin break and fluid motion

Secondary

MeasureTime frameDescription
needling timeduring procedure/surgerytime from puncturing skin until access in vein (in seconds)
number of skin puncturesduring procedure/surgerytotal skin breaks needed before successful entry in vein
number of needle withdrawalsduring procedure/surgeryredirections of needle \>5mm without needing new skin breaks
imaging timeduring procedure/surgerytime from placing USprobe until start needling (in seconds)
operator satisfactionprocedure/surgerysatisfaction of operator with visual feedback from US, rated on Likert Scale 1-5 with 1 no satisfaction at all and 5 totally satisfied
needle visibilityprocedure/surgeryvisualization of needle during procedure on US screen, rating from good - adequate - poor
number of posterior wall puncturesduring procedure/surgerypuncture of posterior wall of jugular vein

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026