Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000223538
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
2/06/2006
Date last updated
2/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of success rate, speed of insertion and acute complication rates of central venous catheter (CVC) insertion between using ultrasound guidance technique and traditional anatomical landmark technique in elective surgery
Scientific title
Comparison of success rate, speed of insertion and acute complication rates of central venous catheter (CVC) insertion between using ultrasound guidance technique and traditional anatomical landmark technique in elective surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective surgery with planned central venous catheter (CVC) insertion 1201 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Central venous catheter (CVC) insertion by using ultrasound guidance technique in the immediate perioperative period of elective surgery
Intervention code [1] 1043 0
Other interventions
Comparator / control treatment
Central venous catheter (CVC) insertion by using traditional anatomical landmark technique in the immediate perioperative period of elective surgery
Control group
Active

Outcomes
Primary outcome [1] 1743 0
Success rate of CVC insertion during perioperative period
Timepoint [1] 1743 0
At time of insertion and chest X-ray assessment that occurs within 24 hour
Primary outcome [2] 1744 0
Speed of CVC insertion during perioperative period
Timepoint [2] 1744 0
At time of insertion and chest X-ray assessment that occurs within 24 hour
Primary outcome [3] 1745 0
Acute complication rate within 24 hours
Timepoint [3] 1745 0
At time of insertion and chest X-ray assessment that occurs within 24 hour
Secondary outcome [1] 3099 0
No secondary outcome
Timepoint [1] 3099 0

Eligibility
Key inclusion criteria
Patients for elective planned CVC in operating theatres.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unplanned CVC insertion. Known difficult CVC insertion or neck abnormality.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
190
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1412 0
Charities/Societies/Foundations
Name [1] 1412 0
St Vincent's Health Research Grant
Country [1] 1412 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St Vincent's Hospital , Melbourne
Address
Country
Australia
Secondary sponsor category [1] 1238 0
None
Name [1] 1238 0
Nil
Address [1] 1238 0
Country [1] 1238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2769 0
Victorian Department of Human Services, Human Research Ethics Committee
Ethics committee address [1] 2769 0
Ethics committee country [1] 2769 0
Australia
Date submitted for ethics approval [1] 2769 0
Approval date [1] 2769 0
Ethics approval number [1] 2769 0
A002/05

Summary
Brief summary
A prospective randomised controlled trial to assess the potential benefits and acute complication rates of ultrasound guided CVC insertion with traditional anatomical landmark insertion technique
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35901 0
Address 35901 0
Country 35901 0
Phone 35901 0
Fax 35901 0
Email 35901 0
Contact person for public queries
Name 10232 0
Lisa Chih-Mei Lin
Address 10232 0
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 10232 0
Australia
Phone 10232 0
+61 3 92882211
Fax 10232 0
Email 10232 0
[email protected]
Contact person for scientific queries
Name 1160 0
Lisa Chih-Mei Lin
Address 1160 0
Department of Anaesthesia
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 1160 0
Australia
Phone 1160 0
+61 3 92882211
Fax 1160 0
Email 1160 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.