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

NCT00639197 | Unknown

• 1 other identifier: 08-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Bacteremia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Reduction in Technical difficulty

  6-8 weeks for the whole 20 pts.

Secondary Outcomes (1)

• Signs of line related blood stream infection/bacteremia.

  6-8 weeks for all 20 pts.

Study Arms (2)

1

ACTIVE COMPARATOR

To Tunnel

Procedure: To tunnel

2

ACTIVE COMPARATOR

Not to tunnel

Procedure: Standard (not to tunnel)

Interventions

To tunnel 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.

1

Standard (not to tunnel) 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ICU patients.
• Likely to need the line for 48 hours.
• Standard central venous catheter.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences Corporation

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

MeSH Terms

Conditions

Infections; Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Salah A Taqi, MBChB

  McMaster Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salah A Taqi, MBChB

CONTACT

905-521-2100; sataqi@hotmail.com

Corey Sawchuk, MD

CONTACT

905-527-4322; ctw_sawchuk@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 20, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: April 11, 2008

Record last verified: 2008-03

Locations

CA (1)