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Clinical Trials/NCT04683302
NCT04683302CompletedNot Applicable

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

Catharina Ziekenhuis Eindhoven1 site in 1 country126 target enrollmentStarted: March 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
126
Locations
1
Primary Endpoint
first pass success

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

control

Active Comparator

conventional 2D guided internal jugular vein catheterization

Intervention: 2D US catheterization (Device)

intervention

Experimental

3D biplanar guided internal jugular vein catheterization

Intervention: 3DUS biplanar catheterization (Device)

Outcomes

Primary Outcomes

first pass success

Time Frame: during procedure/surgery

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

Secondary Outcomes

  • needling time(during procedure/surgery)
  • number of posterior wall punctures(during procedure/surgery)
  • needle visibility(procedure/surgery)
  • imaging time(during procedure/surgery)
  • number of skin punctures(during procedure/surgery)
  • number of needle withdrawals(during procedure/surgery)
  • operator satisfaction(procedure/surgery)

Investigators

Sponsor
Catharina Ziekenhuis Eindhoven
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harm Scholten

MD

Catharina Ziekenhuis Eindhoven

Study Sites (1)

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