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Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization

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ClinicalTrials.gov Identifier: NCT03841968
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Seoul National University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Cardiac Surgical Procedures Central Venous Catheterization Ultrasonography Procedure: Dynamic needle tip positioning under ultrasound-guidance Procedure: Conventional long-axis view Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : March 2, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: Intraoperative ]
    Total procedure time

  2. Rate of posterior wall puncture_assessed by ultrasound [ Time Frame: Intraoperative ]
    Rate of posterior wall puncture_assessed by ultrasound



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03841968


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03841968     History of Changes
Other Study ID Numbers: DNTP IJV
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No