Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization

February 26, 2020 updated by: Seoul National University Hospital

Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective cardiac surgery where central venous catheterization is required.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dynamic needle tip positioning
Procedure: Dynamic needle tip positioning under ultrasound-guidance
The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
Active Comparator: Conventional long-axis
Procedure: Conventional long-axis view
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
Time Frame: Intraoperative
First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedure time
Time Frame: Intraoperative
Total procedure time
Intraoperative
Rate of posterior wall puncture_assessed by ultrasound
Time Frame: Intraoperative
Rate of posterior wall puncture_assessed by ultrasound
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

December 9, 2019

Study Completion (Actual)

December 9, 2019

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DNTP IJV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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