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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00639197
First received: March 11, 2008
Last updated: April 10, 2008
Last verified: March 2008
  Purpose

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 Intervention
Infection
Bacteremia
Procedure: To tunnel
Procedure: Standard (not to tunnel)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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?

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Reduction in Technical difficulty [ Time Frame: 6-8 weeks for the whole 20 pts. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Signs of line related blood stream infection/bacteremia. [ Time Frame: 6-8 weeks for all 20 pts. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639197

Contacts
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

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

No publications provided

Responsible Party: SALAH ALI TAQI, McMaster University
ClinicalTrials.gov Identifier: NCT00639197     History of Changes
Other Study ID Numbers: 08-007
Study First Received: March 11, 2008
Last Updated: April 10, 2008
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 27, 2014