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.
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.
Secondary ID [1] 281821 0
None
Universal Trial Number (UTN)
U1111-1138-7673
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Requirement for PICC insertion 288171 0
Condition category
Condition code
Anaesthesiology 288533 288533 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286372 0
Not applicable
Comparator / control treatment
Previous data from ad-hoc specialists at same institution 2008
Control group
Historical

Outcomes
Primary outcome [1] 288692 0
Insertion time that is time from skin preparation until application n of the skin dressing, by an independent observer using standardised form.
Timepoint [1] 288692 0
this outcome will be assessed by an independent observer during the procedure (medical student).
Secondary outcome [1] 300772 0
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
Timepoint [1] 300772 0
this will be assessed prospectively at the time of procedure
Secondary outcome [2] 300794 0
A 4 week interview via phone call to patient to review patient satisfaction and reason for removal
Timepoint [2] 300794 0
This outcome will be assessed at 4 weeks post insertion of the peripheral inserted central catheter

Eligibility
Key inclusion criteria
All Patients presenting for PICC insertion at RMH
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Refusal to participate

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
Date of last participant enrolment
Anticipated
5/08/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 457 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 6212 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 286606 0
Self funded/Unfunded
Name [1] 286606 0
Ruari Orme
Country [1] 286606 0
Australia
Primary sponsor type
Individual
Name
Ruari M Orme
Address
300 Grattan Street, Parkville, Vic, 3050
Country
Australia
Secondary sponsor category [1] 285393 0
None
Name [1] 285393 0
Address [1] 285393 0
Country [1] 285393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288680 0
Melbourne Health
Ethics committee address [1] 288680 0
300 Grattan Street, Parkville, Vic, 3050
Ethics committee country [1] 288680 0
Australia
Date submitted for ethics approval [1] 288680 0
Approval date [1] 288680 0
20/12/2012
Ethics approval number [1] 288680 0
QA 2012144

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37242 0
Dr Ruari M Orme
Address 37242 0
300 Grattan Street, Parkville, Vic, 3050
Country 37242 0
Australia
Phone 37242 0
+61 3 9342 7000
Fax 37242 0
Email 37242 0
ruari.orme@mh.org.au
Contact person for public queries
Name 37243 0
Dr Ruari M Orme
Address 37243 0
300 Grattan Street, Parkville, Vic, 3050
Country 37243 0
Australia
Phone 37243 0
+61 3 9342 7000
Fax 37243 0
Email 37243 0
ruari.orme@mh.org.au
Contact person for scientific queries
Name 37244 0
Dr Ruari M Orme
Address 37244 0
300 Grattan Street, Parkville, Vic, 3050
Country 37244 0
Australia
Phone 37244 0
+61 3 9342 7000
Fax 37244 0
Email 37244 0
ruari.orme@mh.org.au

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
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Documents added automatically
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