Trial Review

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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
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
Universal Trial Number (UTN)
Trial acronym
PICCUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insertion of Peripheral Inserted Central Catheters 3356 0
Condition category
Condition code
Anaesthesiology 3513 3513 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 3091 0
Treatment: Devices
Comparator / control treatment
Peripheral Inserted Central Catheters without ultrasound
Control group
Active

Outcomes
Primary outcome [1] 4414 0
Time for insertion of peripheral inserted central catheter
Timepoint [1] 4414 0
At time of insertion
Secondary outcome [1] 7450 0
Vein visibility to the naked eye
Timepoint [1] 7450 0
at time of insertion
Secondary outcome [2] 7451 0
number of attempts
Timepoint [2] 7451 0
at time of insertion
Secondary outcome [3] 7452 0
patient satisfaction with questionnaire
Timepoint [3] 7452 0
4 weeks post peripheral inserted central catheter insertion
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)
Timepoint [4] 7453 0
4 weeks post peripheral inserted central catheter insertion

Eligibility
Key inclusion criteria
All peripheral inserted central catheters at Royal Melbourne Hospital
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy and lactation
refusal

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
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)

Funding & Sponsors
Funding source category [1] 3548 0
Self funded/Unfunded
Name [1] 3548 0
Ruari M Orme
Country [1] 3548 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street Parkville 3050
Country
Australia
Secondary sponsor category [1] 3186 0
None
Name [1] 3186 0
Address [1] 3186 0
Country [1] 3186 0
Other collaborator category [1] 324 0
Individual
Name [1] 324 0
Keat Lee
Address [1] 324 0
300 Grattan Street Parkville 3050
Country [1] 324 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5589 0
Ethics committee address [1] 5589 0
Ethics committee country [1] 5589 0
Date submitted for ethics approval [1] 5589 0
10/07/2008
Approval date [1] 5589 0
Ethics approval number [1] 5589 0
2008.125

Summary
Brief summary
Observation of difference in insertion time, complications and patient satisfaction of Peripheral inserted central catheters with and without ultrasound
Trial website
No
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28721 0
Address 28721 0
Country 28721 0
Phone 28721 0
Fax 28721 0
Email 28721 0
Contact person for public queries
Name 11878 0
Dr Ruari Orme
Address 11878 0
300 Grattan Street Parkville 2050
Country 11878 0
Australia
Phone 11878 0
03 93427000
Fax 11878 0
03 93427540
Email 11878 0
[email protected]
Contact person for scientific queries
Name 2806 0
Dr Ruari Orme
Address 2806 0
300 Grattan Street Parkville 3050
Country 2806 0
Australia
Phone 2806 0
03 93427000
Fax 2806 0
03 93427540
Email 2806 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.