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

Primary Purpose

Infection, Bacteremia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
To tunnel
Standard (not to tunnel)
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection focused on measuring Tunneling, Short term, central venous catheters, Ultrasound Guided, Internal jugular, Assess safety and improve technical difficulty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hamilton Health Sciences CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

To Tunnel

Not to tunnel

Outcomes

Primary Outcome Measures

Reduction in Technical difficulty

Secondary Outcome Measures

Signs of line related blood stream infection/bacteremia.

Full Information

First Posted
March 11, 2008
Last Updated
April 10, 2008
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00639197
Brief Title
UGIST: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling
Acronym
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?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Bacteremia
Keywords
Tunneling, Short term, central venous catheters, Ultrasound Guided, Internal jugular, Assess safety and improve technical difficulty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
To Tunnel
Arm Title
2
Arm Type
Active Comparator
Arm Description
Not to tunnel
Intervention Type
Procedure
Intervention Name(s)
To tunnel
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard (not to tunnel)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Technical difficulty
Time Frame
6-8 weeks for the whole 20 pts.
Secondary Outcome Measure Information:
Title
Signs of line related blood stream infection/bacteremia.
Time Frame
6-8 weeks for all 20 pts.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salah A Taqi, MBChB
Phone
905-521-2100
Ext
75170
Email
sataqi@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Corey Sawchuk, MD
Phone
905-527-4322
Ext
46698
Email
ctw_sawchuk@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah A Taqi, MBChB
Organizational Affiliation
McMaster Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences Corporation
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Central investigators

12. IPD Sharing Statement

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

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