Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000253000
Ethics application status
Approved
Date submitted
12/03/2010
Date registered
24/03/2010
Date last updated
8/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Peripherally Inserted Central Catheters
Prospective Study of Complications and Parental/Child Satisfaction
Scientific title
Peripherally Inserted Central Catheters
Prospective Study of Complications and Parental/Child Satisfaction
Secondary ID [1] 286671 0
not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complications of peripeherally inserted central venous catheters and patient satisfaction 256960 0
Condition category
Condition code
Anaesthesiology 257103 257103 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Insertion of a peripherally inserted central venous catheter (PICC), study duration 12 months.
Duration of procedure 15-120 min.
Intervention code [1] 256137 0
Not applicable
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257998 0
The frequency of early removal of peripherally inserted central vernous catheters, which is prior to intended treatment finishing, due to complications with the PICC or accidental removal
Outcome assessment by clinical monitoring and follow-up phone calls.
Timepoint [1] 257998 0
Time of insertion and then weekly until removal of device
Secondary outcome [1] 263552 0
The frequency of catheter-related bloodstream infections are defined as bacteraemia/fungaemia in a patient with an intravascular catheter with at least one positive blood culture obtained from a peripheral vein, and/or clinical manifestations of infection (i.e. fever, chills, and/or hypotension), and no apparent course for the bloodstream infection except the catheter. Where this cannot clearly be determined the information will be reviewed by an independent reviewer.
Assessed by clinical examination and follow-up phone calls.
Timepoint [1] 263552 0
Time of insertion and then weekly until removal of device
Secondary outcome [2] 263616 0
The frequency of phlebitis, thrombosis, PICC occlusion
Assessed by clinical examination and follow-up phone calls.
Timepoint [2] 263616 0
Time of insertion and then weekly until removal of device
Secondary outcome [3] 263617 0
mechanical complications (leaking, broken device), accidental dislodgement, haemorrhage, migration, procedure related trauma (pneumothorax, haemothorax and accidental arterial puncture) and death.
Assessed by clinical examination and follow-up phone calls.
Timepoint [3] 263617 0
Time of insertion and then weekly until removal of device
Secondary outcome [4] 263618 0
Child/parental satisfaction with the device.Assessed by clinical examination and follow-up phone calls.
Timepoint [4] 263618 0
Time of insertion and then weekly until removal of device

Eligibility
Key inclusion criteria
insertion of peripherally inserted central venous catheters (PICC) in theatre or paediatric intensive care unit (PICU)
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
6/03/2012
Date of last participant enrolment
Anticipated
Actual
4/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3778 0
Princess Margaret Hospital - Subiaco

Funding & Sponsors
Funding source category [1] 256640 0
Hospital
Name [1] 256640 0
Princess Margaret Hospital for Children
Country [1] 256640 0
Australia
Primary sponsor type
Individual
Name
Britta Regli-von Ungern-Sternberg
Address
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country
Australia
Secondary sponsor category [1] 255927 0
Individual
Name [1] 255927 0
Neil Chambers
Address [1] 255927 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country [1] 255927 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292809 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 292809 0
Ethics committee country [1] 292809 0
Australia
Date submitted for ethics approval [1] 292809 0
Approval date [1] 292809 0
12/02/2012
Ethics approval number [1] 292809 0
GEKO 3630

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30926 0
Prof Britta Regli-von Ungern-Sternberg
Address 30926 0
Department of Anaesthesia
Princess Margaret Hospital
Roberts Road
SUBIACO
WA 6008
Country 30926 0
Australia
Phone 30926 0
+61893408109
Fax 30926 0
Email 30926 0
[email protected]
Contact person for public queries
Name 14173 0
Britta Regli-von Ungern-Sternberg
Address 14173 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 14173 0
Australia
Phone 14173 0
+61893408109
Fax 14173 0
Email 14173 0
[email protected]
Contact person for scientific queries
Name 5101 0
Britta Regli-von Ungern-Sternberg
Address 5101 0
Department of Anaesthesia
Roberts Road
SUBIACO, WA 6008
Country 5101 0
Australia
Phone 5101 0
+61893408109
Fax 5101 0
Email 5101 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
SourceTitleYear of PublicationDOI
EmbaseA prospective journey of the peripherally inserted central catheter service, at a tertiary paediatric centre in Western Australia.2020https://dx.doi.org/10.1111/aas.13539
N.B. These documents automatically identified may not have been verified by the study sponsor.