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

Infection Clinical Trial

— UGIST  

Official title:

UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00639197
• Other study ID #: 08-007
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2008
• Last updated: April 10, 2008
• Start date: March 2008

Study information

• Verified date: March 2008
• Source: McMaster University
• Contact: Salah A Taqi, MBChB
• Phone: 905-521-2100
• Email: sataqi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Infection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Technical difficulty		6-8 weeks for the whole 20 pts.	Yes
Secondary	Signs of line related blood stream infection/bacteremia.		6-8 weeks for all 20 pts.	No