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Trial registered on ANZCTR


Registration number
ACTRN12618000599279
Ethics application status
Approved
Date submitted
11/04/2018
Date registered
18/04/2018
Date last updated
15/07/2022
Date data sharing statement initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an integrated securement device (ISD) or tissue adhesive (TA) versus standard care (bordered polyurethane) dressings on arterial catheter failure in paediatric patients
Scientific title
Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to evaluate an integrated securement device and tissue adhesive for arterial catheters in paediatric patients
Secondary ID [1] 292696 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The SMILE trial: Paediatrics arterial
Linked study record
This is an follow-up trial to ACTRN12616001073493, which compared similar interventions for Peripheral Venous Catheters.

Health condition
Health condition(s) or problem(s) studied:
Arterial device failure prior to completion of therapy 304450 0
Condition category
Condition code
Public Health 303782 303782 0 0
Health service research
Infection 303783 303783 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will have intra-arterial catheters (IAC) inserted in paediatric intensive care departments and operating theatres. Consenting patients will have their IAC dressed and secured with one of the three following randomly assigned options:

Arm 1 (Control): Bordered polyurethane dressing (BPU), with foam applied as per hospital policy.

Arm 2 (Intervention): Integrated securement device, with a sterile foam cushioning applied. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product.

Arm 3 (Intervention): Tissue Adhesive (TA). TA is a medical grade 'superglue' (cyanoacrylate) used mainly to close skin lacerations/wounds as an alternative to sutures and staples. A bordered polyurethane dressing (with foam) will also applied as per hospital policy.

Patients will be monitored daily to ensure protocol adherence and assess for any complications. The randomly allocated dressing will be applied from device insertion and changed as clinically indicated until removal of device.
Intervention code [1] 300467 0
Prevention
Intervention code [2] 300469 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their arterial catheter secured with a bordered foam polyurethane dressing as per standard care (defined by most common practice among clinicians), at the time of PVC insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 305471 0
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). Feasibility (as a composite outcome) will be defined by a measures including: patient eligibility (more than 80% of those screened); consent (more than 80% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); retention (less than 5% of enrolled patients lost to follow up) and staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [1] 305471 0
On device removal or at the time of trial completion (as appropriate).
Primary outcome [2] 305472 0
All cause IAC failure.

A composite of infection (laboratory confirmed local or bloodstream infection), occlusion, dislodgement (complete or partial), infiltration / extravasation, local arterial inflammation, thrombosis, and inaccurate arterial pressure trace. This composite measure incorporates the multifocal path to the same endpoint; IAC failure. These will be assessed by either the Research Nurse (during daily checks); recorded on a 1 page data collection sheet at the patient's bedside by the treating clinician; or identified in a review of the patient's medical record.
Timepoint [2] 305472 0
At the time of IAC removal.
Secondary outcome [1] 345369 0
Infection (laboratory confirmed local or bloodstream infection): IAC skin and tip samples for culture may be collected by RNs upon IAC removal if clinical suspicion of local infection. Blood cultures may be be collected by RNs throughout the life of the device if clinical suspicion of systemic infection.
Timepoint [1] 345369 0
Whilst the IAC is insitu and on device removal
Secondary outcome [2] 345370 0
Occlusion: Defined as the IAC will not aspirate, infuse, or leakage occurs when fluid is infused.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [2] 345370 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [3] 345371 0
Dislodgement (a composite of partial or complete):
Partial - Change in IAC length at insertion site (inner catheter visible). This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Complete - IAC completely leaves the artery. This will be recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record by the treating clinician.
Timepoint [3] 345371 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [4] 345372 0
Local inflammation of the artery: defined as 2 or more of pain, redness, swelling and a palpable cord.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [4] 345372 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [5] 345373 0
Thombosis (either suspected or confirmed): A composite measure of:
Suspected - As per treating clinician. This will be assessed by the treating clinician, recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Confirmed - Ultrasound confirmed thrombosed vessel at the IAC site. This will be identified by a review of the patient's medical records (including ultrasound findings).
Timepoint [5] 345373 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [6] 345374 0
Interruption of arterial pressure trace: unable to accurately measure blood pressure via device

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [6] 345374 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [7] 345375 0
IAC dwell time: Research staff will calculate time (in hours) from device insertion until removal using relevant information as recorded by clinical staff on a 1 page data collection sheet at the patients bedside and in the patients medical record.
Timepoint [7] 345375 0
At the time of IAC removal
Secondary outcome [8] 345376 0
Skin safety: Skin reactions related to dressings and securements will be monitored including itch; rash (raised or not raised); maceration; blistering; skin tearing; bruising; and pressure areas.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [8] 345376 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [9] 345377 0
Infiltration and Extravasation: A composite measure defined as an infusion leaking into subcutaneous tissue with/without surrounding tissue damage.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [9] 345377 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [10] 345378 0
First dressing duration: time until first dressing requires changing due to non-routine causes.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [10] 345378 0
Daily from IAC insertion until the time of first dressing change.
Secondary outcome [11] 345379 0
Non-routine dressing change frequency.

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [11] 345379 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [12] 345380 0
Staff acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [12] 345380 0
At the time of IAC removal.
Secondary outcome [13] 345381 0
Adhesion: Is the dressing intact, dressing lifting (slightly on the edges) or dressing lifting (a great deal).

This will be assessed by either the Research Nurse (during daily checks), or (if identified by the treating clinician) recorded on a 1 page data collection sheet at the patient's bedside or in the patient's medical record.
Timepoint [13] 345381 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [14] 345582 0
Patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [14] 345582 0
At the time of IAC removal

Eligibility
Key inclusion criteria
1. Informed written consent
2. IAC to be inserted
3. IAC scheduled/expected use >24 hours
4. Patient aged 18 years or below
5, Patients admitted to the Intensive Care Unit
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known, current bloodstream infection (within 48 hours)
2. Non-English speakers without interpreter
3. IACs inserted through diseased, burned or scarred skin
4, IACs inserted into the femoral artery
5. Current skin tear/‘papery’ skin at high risk of tear
6. Known allergy to any study product
7. Previous enrolment in the current study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research nurses (RNs) will screen patients daily and liaise heavily with the staff responsible for inserting the majority of IACs (anaesthetists, intensive care doctors). All eligible patients and their representatives will be approached for written informed consent by the RN. If this is given, the staff member will log in to a centralised web-based randomisation service customised for the trial and be advised of group allocation. Computer generated allocation is provided by an independent randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Randomisation will be in a 1:1:1 ratio between the three study groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/08/2019
Actual
17/09/2020
Date of last participant enrolment
Anticipated
30/08/2021
Actual
5/11/2021
Date of last data collection
Anticipated
3/09/2021
Actual
8/11/2021
Sample size
Target
120
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10630 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 22348 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 297337 0
Commercial sector/Industry
Name [1] 297337 0
Centurion Medical Products
Country [1] 297337 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 296310 0
None
Name [1] 296310 0
Not applicable
Address [1] 296310 0
Not applicable
Country [1] 296310 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298438 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298438 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane, QLD, 4101
Ethics committee country [1] 298438 0
Australia
Date submitted for ethics approval [1] 298438 0
19/04/2016
Approval date [1] 298438 0
26/05/2016
Ethics approval number [1] 298438 0
HREC/16/QRCH/75
Ethics committee name [2] 300117 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 300117 0
Office for Research
Bray Centre, Nathan Campus
Nathan, QLD, 4111
Ethics committee country [2] 300117 0
Australia
Date submitted for ethics approval [2] 300117 0
26/05/2016
Approval date [2] 300117 0
17/06/2016
Ethics approval number [2] 300117 0
NRS/2016/487

Summary
Brief summary
The primary aim of this study is to pilot test the feasibility of a randomised trial that compares the effectiveness of new generation securement and dressing products for intra-arterial catheters (IAC). The RCT aims to (i) identify clinical, cost-effective methods to prevent catheter failure due to infection, inflammation, occlusion, infiltration/extravasation, dislodgement and/or poor trace; (ii) compare usual care dressings with two novel methods; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles.

You or your child may be eligible to participate in this trial if you are an intensive care patient under the age of 18 and are having an intra-arterial catheter inserted as part of your required therapy (which is expected to remain in place for at least 24 hours).

All participants enrolled in this trial will be randomly allocated (by chance) to receive one of three IAC securement options. This will be either the standard bordered polyurethane dressing; medical grade superglue, or an integrated securement device.

The allocated dressing will be applied from device insertion until the time of device removal. Participants and families will be asked to rate the acceptability of the device and dressing, and the device will be observed closely to examine side effects, and device failures. It is hoped that the findings of this trial will provide information on which IAC securements are most effective in preventing IAC failure among paediatric patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77090 0
Prof Claire Rickard
Address 77090 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 77090 0
Australia
Phone 77090 0
+61 7 3735 6460
Fax 77090 0
Email 77090 0
[email protected]
Contact person for public queries
Name 77091 0
Emily Larsen
Address 77091 0
Centre for Clinical Nursing (Nursing and Midwifery Research Centre)
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 77091 0
Australia
Phone 77091 0
+61 7 36468725
Fax 77091 0
Email 77091 0
[email protected]
Contact person for scientific queries
Name 77092 0
Claire Rickard
Address 77092 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 77092 0
Australia
Phone 77092 0
+61 7 3735 6460
Fax 77092 0
Email 77092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per ethical approval conditions, IPD is not available for this trial.


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.