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Sponsored by: |
Hamilton Health Sciences |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00639197 |
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 |
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Infection Bacteremia |
Procedure: To tunnel Procedure: Standard (not to tunnel) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications? |
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 |
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1: Active Comparator
To Tunnel
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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.
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2: Active Comparator
Not to tunnel
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Salah A Taqi, MBChB | McMaster Health Sciences |
Responsible Party: | McMaster University ( SALAH ALI TAQI ) |
Study ID Numbers: | 08-007 |
Study First Received: | March 11, 2008 |
Last Updated: | April 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00639197 |
Health Authority: | Canada: Ethics Review Committee |
Tunneling Short term central venous catheters |
Ultrasound Guided Internal jugular Assess safety and improve technical difficulty |
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis Bacteremia Inflammation |
Pathologic Processes Infection |