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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bacteremia; Infection
• Intervention / Treatment: Procedure: To tunnel; Procedure: Standard (not to 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton Health Sciences Corporation
      • Principal Investigator: Central investigators

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in Technical difficulty	6-8 weeks for the whole 20 pts.

Secondary Outcome Measures

Outcome Measure	Time Frame
Signs of line related blood stream infection/bacteremia.	6-8 weeks for all 20 pts.

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Investigators: Principal Investigator: Salah A Taqi, MBChB, McMaster Health Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): June 1, 2008

Study Registration Dates

• First Submitted: March 11, 2008
• First Submitted That Met QC Criteria: March 14, 2008
• First Posted (Estimate): March 20, 2008

Study Record Updates

• Last Update Posted (Estimate): April 11, 2008
• Last Update Submitted That Met QC Criteria: April 10, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: central venous catheters; Ultrasound Guided; Tunneling; Short term; Internal jugular; Assess safety and improve technical difficulty
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: 08-007