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CompletedNCT03841968Updated Feb 28, 2020

Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization

An interventional study of Dynamic needle tip positioning under ultrasound-guidance and Conventional long-axis view in Cardiac Surgical Procedures, Central Venous Catheterization and Ultrasonography, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization.

SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel.

The aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.

02

Conditions studied

  • Cardiac Surgical Procedures
  • Central Venous Catheterization
  • Ultrasonography
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Elective cardiac surgery where central venous catheterization is required.

Exclusion criteria

Exclusion Criteria:

  • skin infection or trauma
  • Shock
  • Patients on ECMO or IABP support
  • Morbid obesity
  • Profound coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
146 participants (actual)

Study arms

  • Active comparator
    Dynamic needle tip positioning

    Dynamic needle tip positioning

    Procedure: Dynamic needle tip positioning under ultrasound-guidance

  • Active comparator
    Conventional long-axis

    Conventional long-axis

    Procedure: Conventional long-axis view

Interventions

  • ProcedureDynamic needle tip positioning under ultrasound-guidance

    The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.

  • ProcedureConventional long-axis view

    The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

06

What researchers measure

Primary outcomes

  1. First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor

    First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor

    Time frame: Intraoperative

Secondary outcomes

  1. Total procedure time

    Total procedure time

    Time frame: Intraoperative

  2. Rate of posterior wall puncture_assessed by ultrasound

    Rate of posterior wall puncture_assessed by ultrasound

    Time frame: Intraoperative

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03841968
Lead sponsor
Seoul National University Hospital
Collaborators
SMG-SNU Boramae Medical Center
Responsible party
Sponsor
First posted
Feb 15, 2019
Start date
Mar 11, 2019
Primary completion
Dec 9, 2019
Completion
Dec 9, 2019
Last update
Feb 28, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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