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Trial registered on ANZCTR
Registration number
ACTRN12608000353392
Ethics application status
Not yet submitted
Date submitted
2/07/2008
Date registered
24/07/2008
Date last updated
24/07/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective Cohort Observational Study of Peripheral Inserted Central Catheters using Ultrasound
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Scientific title
Ultrasound reduces time for insertion of Peripheral inserted central catheters in patients requiring peripheral inserted central catheters at the discretion of their treating doctors by referal
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Universal Trial Number (UTN)
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Trial acronym
PICCUP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insertion of Peripheral Inserted Central Catheters
3356
0
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Condition category
Condition code
Anaesthesiology
3513
3513
0
0
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Anaesthetics
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Use of ultrasound to facilitate Peripheral Inserted Central Catheter insertion by locating the vein to be cannulated and by facilitating needle insertion under direct ultrasonic vision
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Intervention code [1]
3091
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Treatment: Devices
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Comparator / control treatment
Peripheral Inserted Central Catheters without ultrasound
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Control group
Active
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Outcomes
Primary outcome [1]
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Time for insertion of peripheral inserted central catheter
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Assessment method [1]
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Timepoint [1]
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At time of insertion
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Secondary outcome [1]
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Vein visibility to the naked eye
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Assessment method [1]
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Timepoint [1]
7450
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at time of insertion
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Secondary outcome [2]
7451
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number of attempts
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Assessment method [2]
7451
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Timepoint [2]
7451
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at time of insertion
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Secondary outcome [3]
7452
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patient satisfaction with questionnaire
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Assessment method [3]
7452
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Timepoint [3]
7452
0
4 weeks post peripheral inserted central catheter insertion
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Secondary outcome [4]
7453
0
PICC complications ie thrombosis of upper limb veins (clinical evaluation), occlusion of lumens of peripheral inserted central catheter, local or systemic infection (clinical evaluation)
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Assessment method [4]
7453
0
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Timepoint [4]
7453
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4 weeks post peripheral inserted central catheter insertion
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Eligibility
Key inclusion criteria
All peripheral inserted central catheters at Royal Melbourne Hospital
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Minimum age
18
Years
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Maximum age
N/A
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Pregnancy and lactation
refusal
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
3548
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Ruari M Orme
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Address [1]
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RMH 300 Grattan Street Parkville 3050
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Country [1]
3548
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Australia
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Primary sponsor type
Hospital
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Name
Royal Melbourne Hospital
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Address
300 Grattan Street Parkville 3050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
3186
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Country [1]
3186
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Other collaborator category [1]
324
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Individual
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Name [1]
324
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Keat Lee
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Address [1]
324
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300 Grattan Street Parkville 3050
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Country [1]
324
0
Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
5589
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Ethics committee address [1]
5589
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Ethics committee country [1]
5589
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Date submitted for ethics approval [1]
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10/07/2008
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Approval date [1]
5589
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Ethics approval number [1]
5589
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2008.125
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Summary
Brief summary
Observation of difference in insertion time, complications and patient satisfaction of Peripheral inserted central catheters with and without ultrasound
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Trial website
No
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
28721
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Address
28721
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Country
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Phone
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Fax
28721
0
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Email
28721
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Contact person for public queries
Name
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Dr Ruari Orme
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Address
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300 Grattan Street Parkville 2050
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Country
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Australia
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Phone
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03 93427000
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Fax
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03 93427540
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Email
11878
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[email protected]
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Contact person for scientific queries
Name
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Dr Ruari Orme
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Address
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300 Grattan Street Parkville 3050
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Country
2806
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Australia
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Phone
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03 93427000
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Fax
2806
0
03 93427540
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Email
2806
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[email protected]
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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.
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