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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12613000090718
Ethics application status
Approved
Date submitted
22/01/2013
Date registered
23/01/2013
Date last updated
24/01/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Prospective Audit of PICC (Peripheral Inserted Central Catheter) insertion by Nurse led service, comparison with adhoc insertion by Anaesthestists and Trainees.
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Scientific title
Patients at the Royal Melbourne Hospital scheduled for Peripherally inserted Central catheters will be recruited to observe the quality of insertion, success and complication rate.
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Secondary ID [1]
281821
0
None
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Universal Trial Number (UTN)
U1111-1138-7673
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Requirement for PICC insertion
288171
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Condition category
Condition code
Anaesthesiology
288533
288533
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0
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Other anaesthesiology
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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
Follow-up of all PICC lines placed by the Department of Anaesthesia and Pain management in patients booked on emergency theatre booking system (ETBS). During insertion data will be recorded by an independent observer. Baseline data including age, sex, ASA physical status, previous PICC insertion and indication for PICC will be recorded At 4 weeks patient history will be reviewed for complications and the patient telephoned for satisfaction with PICC line.
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Intervention code [1]
286372
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Not applicable
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Comparator / control treatment
Previous data from ad-hoc specialists at same institution 2008
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Control group
Historical
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Outcomes
Primary outcome [1]
288692
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Insertion time that is time from skin preparation until application n of the skin dressing, by an independent observer using standardised form.
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Assessment method [1]
288692
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Timepoint [1]
288692
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this outcome will be assessed by an independent observer during the procedure (medical student).
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Secondary outcome [1]
300772
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complications at the time of insertion - that is failure of insertion, arterial puncture, acute thrombosis, inability to insert catheter, this will be assessed prospectively at the time of procedure using audit data
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Assessment method [1]
300772
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Timepoint [1]
300772
0
this will be assessed prospectively at the time of procedure
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Secondary outcome [2]
300794
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A 4 week interview via phone call to patient to review patient satisfaction and reason for removal
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Assessment method [2]
300794
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Timepoint [2]
300794
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This outcome will be assessed at 4 weeks post insertion of the peripheral inserted central catheter
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Eligibility
Key inclusion criteria
All Patients presenting for PICC insertion at RMH
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Minimum age
18
Years
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Maximum age
No limit
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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
Refusal to participate
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Study design
Purpose
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Duration
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Selection
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Timing
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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
4/03/2013
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Actual
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Date of last participant enrolment
Anticipated
5/08/2013
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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
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
457
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
6212
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3050 - Royal Melbourne Hospital
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Funding & Sponsors
Funding source category [1]
286606
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Self funded/Unfunded
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Name [1]
286606
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Ruari Orme
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Address [1]
286606
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300 Grattan Street Parkville, Vic 3050
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Country [1]
286606
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Australia
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Primary sponsor type
Individual
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Name
Ruari M Orme
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Address
300 Grattan Street, Parkville, Vic, 3050
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Country
Australia
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Secondary sponsor category [1]
285393
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None
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Name [1]
285393
0
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Address [1]
285393
0
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Country [1]
285393
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288680
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Melbourne Health
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Ethics committee address [1]
288680
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300 Grattan Street, Parkville, Vic, 3050
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Ethics committee country [1]
288680
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Australia
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Date submitted for ethics approval [1]
288680
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Approval date [1]
288680
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20/12/2012
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Ethics approval number [1]
288680
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QA 2012144
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Summary
Brief summary
All patients presenting for PICC line insertion will be offered follow-up in this audit of Nurse led PICC insertion at the RMH. Time of insertion, success, complications and patient satisfaction will be measured and this data will be compared to same data subsets acquired from same patient population in 2008, but when the service was physcian led.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
37242
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Dr Ruari M Orme
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Address
37242
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300 Grattan Street, Parkville, Vic, 3050
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Country
37242
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Australia
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Phone
37242
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+61 3 9342 7000
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Fax
37242
0
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Email
37242
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[email protected]
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Contact person for public queries
Name
37243
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Dr Ruari M Orme
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Address
37243
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300 Grattan Street, Parkville, Vic, 3050
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Country
37243
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Australia
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Phone
37243
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+61 3 9342 7000
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Fax
37243
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Email
37243
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[email protected]
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Contact person for scientific queries
Name
37244
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Dr Ruari M Orme
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Address
37244
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300 Grattan Street, Parkville, Vic, 3050
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Country
37244
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Australia
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Phone
37244
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+61 3 9342 7000
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Fax
37244
0
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Email
37244
0
[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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