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

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00639197

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:	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?

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

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
1: Active Comparator 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.
2: Active Comparator 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

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

Investigators

Principal Investigator:

Salah A Taqi, MBChB

McMaster Health Sciences

More Information

No publications provided

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 History of Changes
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

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Bacteremia
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Pathologic Processes

Bacteremia
Infection
Inflammation

ClinicalTrials.gov processed this record on September 10, 2009