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

NCT ID: NCT00639197

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

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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

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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.

Conditions

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Infection Bacteremia

Keywords

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Tunneling Short term central venous catheters Ultrasound Guided Internal jugular Assess safety and improve technical difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

To Tunnel

Group Type ACTIVE_COMPARATOR

To tunnel

Intervention Type PROCEDURE

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

Not to tunnel

Group Type ACTIVE_COMPARATOR

Standard (not to tunnel)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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McMaster University

Principal Investigators

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Salah A Taqi, MBChB

Role: PRINCIPAL_INVESTIGATOR

McMaster Health Sciences

Locations

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Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Salah A Taqi, MBChB

Role: CONTACT

Phone: 905-521-2100

Email: [email protected]

Corey Sawchuk, MD

Role: CONTACT

Phone: 905-527-4322

Email: [email protected]

Other Identifiers

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08-007

Identifier Type: -

Identifier Source: org_study_id