Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000101088
Ethics application status
Approved
Date submitted
16/01/2010
Date registered
1/02/2010
Date last updated
15/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-guided axillary vein approach to the subclavian vein versus traditional infraclavicular subclavian vein cannulation for central venous access: a prospective randomised pilot study in intensive care patients
Scientific title
Comparing the success rate of ultrasound-guided axillary vein approach to the subclavian vein versus traditional infraclavicular subclavian vein cannulation for central venous access: a prospective randomised pilot study in intensive care patients
Secondary ID [1] 1323 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
central venous cannulation 256565 0
Condition category
Condition code
Anaesthesiology 256735 256735 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided axillary vein cannulation for central venous access in intensive care patients compared to traditional infraclavicular subclavian vein cannulation for central venous access . Study to be conducted over 1 year, with 40 patients in each arm. Each adult patient requiring a subclavian vein central venous cannulation (CVC) to potentially be enrolled (if no exclusion criteria), then randomised to either intervention. CVC to take approx 20 minutes from initial skin puncture, using the Seldinger technique for cannulation and will occur only once in each participant. Success/Failure of procedure, duration of intervention (from skin puncture to blood flashback) to be recorded, number of skin punctures recorded, if assistance required and any complications (e.g. pneumothorax) recorded. Post-procedure Chest Xray to determine position of catheter tip (ie in Superior Vena Cava).
Intervention code [1] 255833 0
Treatment: Devices
Comparator / control treatment
Traditional infraclavicular subclavian vein cannulation for central venous access. Study to be conducted over 1 year, with 40 patients in control group. Each adult patient requiring a subclavian vein central venous cannulation (CVC) to potentially be enrolled (if no exclusion criteria), then randomised to either intervention. CVC to take approx 20 minutes from initial skin puncture, using the Seldinger technique for cannulation and will occur only once in each participant. Success/Failure of procedure, duration of intervention (from skin puncture to blood flashback) to be recorded, number of skin punctures recorded, if assistance required and any complications (e.g. pneumothorax) recorded. Post-procedure Chest Xray to determine position of catheter tip (ie in Superior Vena Cava).
Control group
Active

Outcomes
Primary outcome [1] 257617 0
1. Success/Failure of central venous cannulation - success indicated by flashback of venous blood into catheter ports, failure indicated if unable to aspirate blood from catheter ports following attempted insertion.
Timepoint [1] 257617 0
1. At end of cannulation procedure
Primary outcome [2] 257618 0
2. Position of cannula: if tip in Superior Vena Cava = correct position, any other position = misplaced
Timepoint [2] 257618 0
2. At end of cannulation procedure, after Chest Xray performed
Primary outcome [3] 257619 0
3. Number of skin punctures before successful cannulation (>3 = difficult and procedure recorded as Failed)
Timepoint [3] 257619 0
3. Recorded from start of first skin puncture until successful cannulation
Primary outcome [4] 257620 0
4. Time taken for successful cannulation (>20 mins = difficult and procedure to be abandoned and recorded as Failed)
Timepoint [4] 257620 0
4. Clock commenced when the first skin puncture is made and stopped when blood flashback in to the syringe is seen
Primary outcome [5] 257621 0
5. Complications of procedure e.g. local bleeding/haematoma or pneumothorax
Timepoint [5] 257621 0
5. Recorded during procedure or immediately after the procedure e.g. pneumothorax evidenced on post-procedure Chest Xray
Secondary outcome [1] 262891 0
nil
Timepoint [1] 262891 0
nil

Eligibility
Key inclusion criteria
All patients requiring a subclavian central venous cannula as part of their treatment/monitoring in the Intensive Care Unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring a central venous cannula but with overlying infection, burn or skin damage at puncture site; coagulopathy; pneumothorax on contralateral side; distorted anatomy or trauma at cannulation site

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256325 0
Hospital
Name [1] 256325 0
The Northern Hospital Intensive Care Unit
Country [1] 256325 0
Australia
Primary sponsor type
Individual
Name
Dr Robert Melvin
Address
Emergency Registrar
The Northern Hospital
185 Cooper Street
Epping
VIC 3076
Country
Australia
Secondary sponsor category [1] 251643 0
Individual
Name [1] 251643 0
Dr DeVillers Smit
Address [1] 251643 0
Emergency Physician
The Northern Hospital
185 Cooper Street
Epping
VIC 3076
Country [1] 251643 0
Australia
Other collaborator category [1] 1038 0
Individual
Name [1] 1038 0
Dr Graham Duke
Address [1] 1038 0
Intensive Care Director
The Northern Hospital
185 Cooper Street
Epping
VIC 3076
Country [1] 1038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258406 0
Ethics committee address [1] 258406 0
Ethics committee country [1] 258406 0
Date submitted for ethics approval [1] 258406 0
20/01/2010
Approval date [1] 258406 0
Ethics approval number [1] 258406 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30715 0
Address 30715 0
Country 30715 0
Phone 30715 0
Fax 30715 0
Email 30715 0
Contact person for public queries
Name 13962 0
Dr Robert Melvin
Address 13962 0
The Northern Hospital
185 Cooper Street
Epping
VIC 3076
Country 13962 0
Australia
Phone 13962 0
+61384058000
Fax 13962 0
Email 13962 0
[email protected]
Contact person for scientific queries
Name 4890 0
Dr Robert Melvin
Address 4890 0
The Northern Hospital
185 Cooper Street
Epping
VIC 3076
Country 4890 0
Australia
Phone 4890 0
+61384058000
Fax 4890 0
Email 4890 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.