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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03841968
Other study ID # DNTP IJV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2019
Est. completion date December 9, 2019

Study information

Verified date February 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date December 9, 2019
Est. primary completion date December 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Dynamic needle tip positioning under ultrasound-guidance
The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
Conventional long-axis view
The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intraoperative
Secondary Total procedure time Total procedure time Intraoperative
Secondary Rate of posterior wall puncture_assessed by ultrasound Rate of posterior wall puncture_assessed by ultrasound Intraoperative
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