Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000563763
Ethics application status
Not yet submitted
Date submitted
14/05/2013
Date registered
17/05/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Cyanoacrylate Adhesive and Polyurethane Dressings in Arterial Catheter Securement
Scientific title
The securement of arterial lines in intensive care patients comparing cyanoacrylate adhesive and polyurethane dressings in terms of failure rate
Secondary ID [1] 282505 0
Nil
Universal Trial Number (UTN)
U1111-1143-0797
Trial acronym
CAPDACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial catheter securement in intensive care patients 289159 0
Condition category
Condition code
Anaesthesiology 289486 289486 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cyanoacrylate adhesive - n-butyl cyanoacrylate (Histoacryl, B Braun)

Adhesive is applied to the arterial catheter in order to secure it. Adhesive is applied on initial insertion and every three days thereafter. A maximum of 0.5ml of adhesive is to be used during any one application. The adhesive should be applied to the hub of the catheter and the entry site only.
Intervention code [1] 287157 0
Treatment: Devices
Comparator / control treatment
Standard intravenous catheter dressing - Tegaderm IV 1633 (3M)

This dressing is applied on initial insertion and every three days thereafter. Clinicians may use one dressing in a manner of their discretion.
Control group
Active

Outcomes
Primary outcome [1] 289586 0
Failure rate of arterial catheters in %. Failure rate is defined as overt dislodgement of catheter, loss of pressure reading or waveform or inability to aspirate blood from catheter
Timepoint [1] 289586 0
During insertion of arterial catheter, up to one week post-insertion
Secondary outcome [1] 302782 0
Skin damage/irritation - clinical assessment
Timepoint [1] 302782 0
At any time following insertion of catheter and securement until 48 hours post removal of catheter

Eligibility
Key inclusion criteria
Intensive care patients who require an arterial catheter to be inserted in the radial artery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intensive care patients who require an arterial catheter to be inserted in an artery other than the radial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered concealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator on internet
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
8/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1010 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 6884 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 287286 0
Hospital
Name [1] 287286 0
Sir Charles Gairdner Hospital
Country [1] 287286 0
Australia
Funding source category [2] 287287 0
Commercial sector/Industry
Name [2] 287287 0
B Braun Australia
Country [2] 287287 0
Australia
Primary sponsor type
Individual
Name
Dr Tom Ryan
Address
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 286039 0
None
Name [1] 286039 0
Address [1] 286039 0
Country [1] 286039 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289263 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 289263 0
2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 289263 0
Australia
Date submitted for ethics approval [1] 289263 0
01/05/2013
Approval date [1] 289263 0
Ethics approval number [1] 289263 0
2013-084

Summary
Brief summary
The insertion of an arterial catheter is a common intervention in the intensive care unit, allowing continuous haemodynamic monitoring as well as easy access for blood samples and blood gas analysis. Arterial catheterisation is recognised as being a safe procedure, with major complications such as arterial occlusion occurring in less than 1% of cases. Partial or complete dislodgement of arterial catheters, with the attendant risks of re-insertion such as infection and trauma remains an ongoing problem in the intensive care unit. Much effort has been made to improve the standard of securement, with studies focussing on alternative methods of fixation.

The study will compare the rate of failure of arterial catheters secured with cyanoacrylate tissue adhesive (tissue glue) with those secured with traditional bordered polyurethane dressings. Dislodgement and subsequent failure of arterial lines is a relatively common problem in the intensive care unit, with associated costs for replacement in terms of staff time, equipment and consumables used and patient comfort.

Arterial catheters will be randomised to receive either fixation with cyanoacrylate adhesive or traditional dressings. The primary outcome is the rate of failure of arterial catheters. The secondary outcome is skin reactions or injuries secondary to the fixation method used. The study population will be adult patients admitted to the SCGH ICU. The number of patients for this study will be calculated from the previous audit on arterial catheter failure rates. Inclusion criteria will be arterial catheters inserted in the radial artery. Exclusion criteria will be arterial catheters inserted into an artery other than the radial. Failure is defined as the inability to obtain an arterial waveform and subsequent pressure reading via the catheter, the inability to aspirate blood from the catheter or overt physical dislodgement of the catheter from the artery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40054 0
Dr Tom Ryan
Address 40054 0
Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 40054 0
Australia
Phone 40054 0
+61439306337
Fax 40054 0
Email 40054 0
[email protected]
Contact person for public queries
Name 40055 0
Dr Tom Ryan
Address 40055 0
Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 40055 0
Australia
Phone 40055 0
+61439306337
Fax 40055 0
Email 40055 0
[email protected]
Contact person for scientific queries
Name 40056 0
Dr Tom Ryan
Address 40056 0
Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 40056 0
Australia
Phone 40056 0
+61439306337
Fax 40056 0
Email 40056 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.