Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Central Venous Catheterization

NCT01902355 | Completed DMC

• 2 other identifiers: modifiedSeldingerH1305617491
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two needle insertion techniques(Seldinger vs. modified Seldinger technique) on success rate and complications during central venous catheterization.

Conditions

Complications of Central Venous Catheterization

Keywords

Central Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• number of attempts of guidewire advance

  after desired vessel is punctured guidewire is advanced through the lumen of the needle or guiding sheath

  after internal jugular vein puncture

Secondary Outcomes (1)

• complications of internal jugular vein central catheterization

  after central catheter placement

Study Arms (2)

modified Seldinger technique

EXPERIMENTAL

Use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

Procedure: modified Seldinger technique

Seldinger technique

ACTIVE COMPARATOR

The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel.

Procedure: Seldinger technique

Interventions

modified Seldinger technique PROCEDURE

modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

modified Seldinger technique

Seldinger technique PROCEDURE

The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel.

Seldinger technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled for surgery and internal jugular vein central catheterization

You may not qualify if:

• Patient who doesn't agree to the study
• Catheterization site inflammation
• Contralateral diaphragmatic dysfunction
• Anatomic anomalies of carotid artery or vein
• Previous neck surgical history
• Recent(less than 1 month) right internal jugular vein central catheterization

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University of Hospital

Seoul, 110-744, South Korea

Location

Study Officials

• Deok Man Hong, M.D., Ph. D.

  Seoul National University Hospital

  STUDY CHAIR

• Tae Kyong Kim, M.D.

  Seoul National University of Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

KR (1)