Adequate Insertion Depth of Dilator During Central Venous Catheterization

NCT04279808 | Unknown

• 1 other identifier: 10-2019-3
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time ultrasonography.

Conditions

Central Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• hematoma realted with the dilator

  hematoma from the vascular wall puncture by the dilator

  1 Day (on the study day for each patient)

Secondary Outcomes (1)

• distance between skin puncture site and the outside of the anterior wall of the internal jugular vein

  1 Day (on the study day for each patient)

Study Arms (2)

measured distance

EXPERIMENTAL

In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will measure the distance between the skin puncture site and the outside of anterior wall of the jugular vein. Next, we will insert the dilator on the guidewire by the measured length."

Procedure: dilator depth

conventional method

NO INTERVENTION

In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will insert the dilator on the guidewire as commonly used method of the practitioners."

Interventions

dilator depth PROCEDURE

For soft tissue dilation just after guidewire insertion in central venous catheterization through the right internal jugular vein, investigators will measure the distance between the skin puncture site and outside of anterior wall of the vein with real-time ultrasonography in the measured depth group. Next, practitioner will insert the dilator by the measured length and continue to insert the central venous catheter. For the conventional group as a control group, practitioner will perform the central venous catheterization with a manner used routinely by the practitioner.

measured distance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients requiring central venous catheterization through the right internal jugular vein

You may not qualify if:

• suspicion for infection of the right neck site

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Officials

• Jung-Man Lee, M.D.,PhD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung-Man Lee, M.D.,PhD.

CONTACT

+82-2-870-2513; jungman007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: March 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 6, 2020

Record last verified: 2020-02