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

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Unknown status
CT.gov ID
NCT00639197
Collaborator
(none)
20
1
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: To tunnel
  • Procedure: Standard (not to tunnel)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (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?
Study Start Date :
Mar 1, 2008
Anticipated Primary Completion Date :
Jun 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Reduction in Technical difficulty [6-8 weeks for the whole 20 pts.]

Secondary Outcome Measures

  1. Signs of line related blood stream infection/bacteremia. [6-8 weeks for all 20 pts.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Hamilton Health Sciences Corporation Hamilton Ontario Canada L8L 2X2

Sponsors and Collaborators

  • Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Salah A Taqi, MBChB, McMaster Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00639197
Other Study ID Numbers:
  • 08-007
First Posted:
Mar 20, 2008
Last Update Posted:
Apr 11, 2008
Last Verified:
Mar 1, 2008

Study Results

No Results Posted as of Apr 11, 2008