We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

UGIST: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling (UGIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00639197
Recruitment Status : Unknown
Verified March 2008 by McMaster University.
Recruitment status was:  Recruiting
First Posted : March 20, 2008
Last Update Posted : April 11, 2008
Information provided by:

Study Description
Brief Summary:

The purpose of the study is to determine if tunneling standard short-term central lines for a short distance under the skin, with the assistance of ultrasound imaging, reduces the risk of central line infections for catheters placed in the neck vein.

Previous work has shown that these lines can be tunneled without ultrasound guidance. We wish to determine if the use of ultrasound makes the tunneling procedure safer and easier.

Condition or disease Intervention/treatment
Infection Bacteremia Procedure: To tunnel Procedure: Standard (not to tunnel)

Detailed Description:

More than 250,000 vascular catheter-related bloodstream infections occur annually in the USA with a mortality ranging from 12% to 25% in critically ill patients.

It is also widely accepted that the internal jugular site is associated with a higher risk of catheter related infection if compared with the subclavian site.

Therefore, the benefit of catheter tunneling was best seen at the internal jugular site as described by J F Timsit in 1996 in his prospective randomized multicentre study where it significantly decreased the rate of catheter related sepsis from 11.4% to 3.4%.

At the same time, tunneling catheters did not increase the rate of mechanical complications such as pneumothorax, hematoma, or arterial puncture, but it almost doubled the rate of technical difficulties, such as problems with advancing the catheter or multiple puncture sites, at that time it was a blind technique.

Now, and with the introduction of the ultrasound guidance in our routine central line insertions, we would like to evaluate its benefit in reducing the technical difficulty and mechanical complications that used to be encountered while tunneling the short term central venous catheters at the internal jugular site.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications?
Study Start Date : March 2008
Estimated Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
To Tunnel
Procedure: To tunnel
Using the standard Seldinger technique and under the guidance of ultrasound, the catheter will pass through a 3-5cm subcutaneous tunnel before it is eventually secured to reside at the internal jugular vein.
Active Comparator: 2
Not to tunnel
Procedure: Standard (not to tunnel)
Using the standard Seldinger technique and under the guidance of ultrasound, the catheter is secured to reside at the internal jugular vein, without a subcutaneous tunnel.

Outcome Measures

Primary Outcome Measures :
  1. Reduction in Technical difficulty [ Time Frame: 6-8 weeks for the whole 20 pts. ]

Secondary Outcome Measures :
  1. Signs of line related blood stream infection/bacteremia. [ Time Frame: 6-8 weeks for all 20 pts. ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Adult ICU patients.
  • Likely to need the line for 48 hours.
  • Standard central venous catheter.

Exclusion Criteria:

  • Mechanical impedance (e.g C-spine protection).
  • Absent Internal jugular vessel on U/S.
  • Previous line still in place.
  • Presence of overlying skin or tissue infection or mass.
  • Tricuspid valve vegetation.
  • Tumor extending to the right atrium.
  • Persistent coagulopathy.
  • Newly inserted Pacemaker leads.
  • Recent carotid endarterectomy on same side.
  • No ultrasound facility available.
  • Patients requiring special lines (e.g. Dialysis).
Contacts and Locations

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): NCT00639197

Contact: Salah A Taqi, MBChB 905-521-2100 ext 75170 sataqi@hotmail.com
Contact: Corey Sawchuk, MD 905-527-4322 ext 46698 ctw_sawchuk@yahoo.com

Canada, Ontario
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Central investigators         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Salah A Taqi, MBChB McMaster Health Sciences
More Information

Responsible Party: SALAH ALI TAQI, McMaster University
ClinicalTrials.gov Identifier: NCT00639197     History of Changes
Other Study ID Numbers: 08-007
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: March 2008

Keywords provided by McMaster University:
Short term
central venous catheters
Ultrasound Guided
Internal jugular
Assess safety and improve technical difficulty

Additional relevant MeSH terms:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes