ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

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]

During insertion of arterial catheter, up to one week post-insertion

Secondary outcome [1]

Skin damage/irritation - clinical assessment

Timepoint [1]

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?

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)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Recruitment postcode(s) [1]

6009 - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands WA 6009

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

B Braun Australia

Address [2]

17 Lexington Drive
Bella Vista NSW 2153

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Sir Charles Gairdner Group Human Research Ethics Committee

Ethics committee address [1]

2nd Floor A Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2013

Approval date [1]

Ethics approval number [1]

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

Dr Tom Ryan

Address

Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61439306337

Fax

tom.ryan55@gmail.com

Contact person for public queries

Name

Tom Ryan

Address

Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61439306337

Fax

tom.ryan55@gmail.com

Contact person for scientific queries

Name

Tom Ryan

Address

Department of Intensive Care
4th Floor, G Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009

Country

Australia

Phone

+61439306337

Fax

tom.ryan55@gmail.com

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.

Trial Review

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