UGIST: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling (UGIST)
Recruitment status was: Recruiting
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.
|Infection Bacteremia||Procedure: To tunnel Procedure: Standard (not to tunnel)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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?|
- Reduction in Technical difficulty [ Time Frame: 6-8 weeks for the whole 20 pts. ]
- Signs of line related blood stream infection/bacteremia. [ Time Frame: 6-8 weeks for all 20 pts. ]
|Study Start Date:||March 2008|
|Estimated Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639197
|Contact: Salah A Taqi, MBChB||905-521-2100 ext firstname.lastname@example.org|
|Contact: Corey Sawchuk, MD||905-527-4322 ext email@example.com|
|Hamilton Health Sciences Corporation||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator: Central investigators|
|Principal Investigator:||Salah A Taqi, MBChB||McMaster Health Sciences|