InfectionUGISTNCT00639197
UGIST: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling
A study testing To tunnel and Standard (not to tunnel) in people with Infection and Bacteremia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bacteremia
- What is being tested?
- To tunnel and Standard (not to tunnel)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ICU patients.
- Likely to need the line for 48 hours.
- Standard central venous catheter.
Who cannot join
- 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.
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- Persistent coagulopathy.
- Newly inserted Pacemaker leads.
- Recent carotid endarterectomy on same side.
- No ultrasound facility available.
- Patients requiring special lines (e.g. Dialysis).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences Corporation
Hamilton, Ontario, L8L 2X2
Central investigators
About this study
Official title: UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications?
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.
Read the 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.
- Conditions
- Infection, Bacteremia
- Being tested
- To tunnel, Standard (not to tunnel)
- Keywords
- Tunneling, Short term, central venous catheters, Ultrasound Guided, Internal jugular, Assess safety and improve technical difficulty
- Medical subject headings
- Infections, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To tunnelProcedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | To Tunnel Receives: Procedure: To tunnel |
| 2 | Active comparator | Not to tunnel Receives: Procedure: Standard (not to tunnel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Technical difficulty
Measured: 6-8 weeks for the whole 20 pts.
Secondary outcomes (1)
Signs of line related blood stream infection/bacteremia.
Measured: 6-8 weeks for all 20 pts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Salah A Taqi, MBChB, Principal investigator, McMaster Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639197
- Sponsor's protocol ID
- 08-007
- Acronym
- UGIST
- Status last verified
- Mar 2008
- First submitted
- 11 Mar 2008
- Last updated
- 11 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications?
- ClinicalTrials.gov ID
- NCT00639197
- Acronym / sponsor ID
- UGIST / 08-007
- Conditions
- Infection, Bacteremia
- Keywords
- Tunneling, Short term, central venous catheters, Ultrasound Guided, Internal jugular, Assess safety and improve technical difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (estimated)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: To tunnelTo Tunnel |
| 2 | Active comparator | Procedure: Standard (not to tunnel)Not to tunnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult ICU patients.
- Likely to need the line for 48 hours.
- Standard central venous catheter.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To tunnelUsing 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. | Procedure or surgery | 1 |
| 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. | Procedure or surgery | 2 |
Primary outcome
Reduction in Technical difficulty
Time frame: 6-8 weeks for the whole 20 pts.
1 secondary outcome
Signs of line related blood stream infection/bacteremia.
Time frame: 6-8 weeks for all 20 pts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah A Taqi, MBChB principal investigator
McMaster Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To tunnel and Standard (not to tunnel) in people with Infection and Bacteremia, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salah A Taqi, MBChB (905-521-2100 ext. 75170, sataqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Technical difficulty (time frame: 6-8 weeks for the whole 20 pts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2008.