Recruiting

Ultrasound Guidance

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00639197

Conditions

Infection

Bacteremia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

To tunnel

Standard (not to tunnel)

Study Details

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

Study ID

NCT00639197

Start date

Mar, 2008

Status verified date

Mar, 2008

Primary completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

To Tunnel

active comparator: 2

Not to tunnel

Interventions

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.

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.

Primary outcome measure

  • Reduction in Technical difficulty [ Time Frame: 6-8 weeks for the whole 20 pts. ]

Central Contacts and Locations

Central contacts

Locations

Hamilton Health Sciences Corporation

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Central investigators

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 11, 2008

Last verified

Mar, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2008-04-11.