Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000525886
Ethics application status
Approved
Date submitted
16/05/2012
Date registered
17/05/2012
Date last updated
11/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Measurement of vein size using ultrasound in patients prior to Peripherally Inserted Central Catheter insertion.
Scientific title
Vein size and rates of symptomatic deep vein thrombosis (DVT) in patients who have a Peripherally Inserted Central Catheter (PICC).
Secondary ID [1] 280492 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic deep vein thrombosis 286473 0
Risk of thrombus for patients recieving a PICC insertion 286477 0
Condition category
Condition code
Blood 286732 286732 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The diameter of the basilic, brachial and cephalic veins of both arms will be measured using ultrasound prior to PICC insertion.
After vein measurement is complete the researcher will ask the participant to indicate their dominant arm. At this point the PICC inserter will chose the largest vein identified on ultrasound to insert the device and the vein used will be measured at the insertion site. PICC diameter will be obtained from manufacturer information to determine the vein occupation ratio.
At approximately nine weeks post insertion, the unit record number of each patient will be used to gain access to medical records to gather treatment management information as well as be matched to DVT reports generated by the Radiology Department.
Intervention code [1] 284860 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287128 0
To test for an association between catheter/vein occupation ratio and rates of symptomatic DVT. Vein diameter will be determined using ultrasound, catheter diameter will be obtained from manufacturer information. Cases of DVT will be collected from Radiology reports.
Timepoint [1] 287128 0
Medical records and Radiology reports will be accessed at nine weeks post-insertion
Secondary outcome [1] 297445 0
To determine whether the diameter of the basilic, brachial and cephalic veins is larger in the dominant arm compared to the non-dominant arm of patients booked for PICC insertion in a public teaching hospital population. The diameter of veins will be measured using ultrasound.
Timepoint [1] 297445 0
The measurement of both arms with ultrasound will be prior insertion of a PICC

Eligibility
Key inclusion criteria
All adult patients who are to have a single, double or triple lumen PICC inserted above the ante-cubital fossa region (as per normal practice) by the PICC nurse inserter in the Radiology Department
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent due to neurological or language barriers (diagnosis of dementia; uncontrolled mental illness or deficits; inability to read, write or understand English).

Participants with factors that prevent the consideration of one arm for PICC insertion (lymphoedema, amputation, thrombosis, neck surgery, lymph clearance).

Participants who are ambidextrous.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1264 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 285251 0
Self funded/Unfunded
Name [1] 285251 0
Ms. Rebecca Sharp
PhD candidate
Country [1] 285251 0
Australia
Primary sponsor type
Individual
Name
Ms. rebecca Sharp
Address
c/o - School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 284113 0
None
Name [1] 284113 0
Address [1] 284113 0
Country [1] 284113 0
Other collaborator category [1] 277521 0
Individual
Name [1] 277521 0
Ms. Melita Cummings
Address [1] 277521 0
C/- Radiology Department
Royal Adelaide Hospital,
North Terrace,
Adelaide, SA, 5000.
Country [1] 277521 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287261 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 287261 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 287261 0
Australia
Date submitted for ethics approval [1] 287261 0
21/01/2013
Approval date [1] 287261 0
26/03/2013
Ethics approval number [1] 287261 0

Summary
Brief summary
This research will explore the effect of arm dominance on vein diameter and whether vein occupation ratio is predictive of DVT. This will inform current practice and assist in the development of an evidence based protocol for vein assessment and choice to enhance patient safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34181 0
Ms Rebecca Sharp
Address 34181 0
School of Nursing and Midwifery,
Division of Health Sciences,
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country 34181 0
Australia
Phone 34181 0
+61 8 830 21378
Fax 34181 0
Email 34181 0
[email protected]
Contact person for public queries
Name 17428 0
Rebecca Sharp
Address 17428 0
School of Nursing and Midwifery,
Division of Health Sciences,
University of South Australia,
GPO Box 2471 Adelaide SA 5001
Country 17428 0
Australia
Phone 17428 0
+61 8 830 21378
Fax 17428 0
Email 17428 0
[email protected]
Contact person for scientific queries
Name 8356 0
Adrian Esterman
Address 8356 0
Biostatics, division of Health Sciences,
City East Campus of University of South Australia
North Terrace Adelaide,
South Australia, 5000
Australia
Country 8356 0
Australia
Phone 8356 0
+61 8 830 22163
Fax 8356 0
Email 8356 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.