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Trial registered on ANZCTR


Registration number
ACTRN12616001074482
Ethics application status
Approved
Date submitted
5/08/2016
Date registered
10/08/2016
Date last updated
29/01/2020
Date data sharing statement initially provided
29/01/2020
Date results information initially provided
29/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to improve the dressing and securement of arterial catheters inserted in the adult intensive care unit.
Scientific title
Pilot randomised controlled trial testing alternative securement (integrated securement device) to prevent arterial catheter failure for catheters inserted in the adult intensive care unit.
Secondary ID [1] 289862 0
None
Universal Trial Number (UTN)
U1111-1186-1790
Trial acronym
The SMILE Trial: Adult Arterial Catheters
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial device failure prior to completion of therapy 299805 0
Condition category
Condition code
Public Health 299733 299733 0 0
Health service research
Infection 299734 299734 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 adult intensive care departments. Consenting patients will have their IAC dressed and secured with one of the two following randomly assigned options:

Arm 1 (Control): Simple polyurethane dressing (SP), with gauze/foam applied as per hospital policy

Arm 2: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product.

Patients will be monitored daily to ensure protocol adherence. The randomly allocated dressing will be applied from device insertion and changed as clinically indicated until removal of device.
Intervention code [1] 295546 0
Prevention
Intervention code [2] 295547 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their arterial catheter secured with a simple polyurethane dressing, with gauze/foam applied as per hospital policy, (standard care) at the time of catheter insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 299190 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. Feasibility measures will include: 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] 299190 0
On device removal or at the time of trial completion (as appropriate).
Primary outcome [2] 299191 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] 299191 0
At the time of IAC removal.
Secondary outcome [1] 326464 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] 326464 0
Whilst the IAC is insitu and on device removal
Secondary outcome [2] 326465 0
Occlusion: Defined as the IAC will not aspirate, infuse, or leakage occurs when fluid is infused.
Timepoint [2] 326465 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [3] 326466 0
Dislodgement (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] 326466 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [4] 326467 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] 326467 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [5] 326468 0
Thombosis (either suspected or confirmed):
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] 326468 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [6] 326469 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] 326469 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [7] 326470 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] 326470 0
At the time of IAC removal
Secondary outcome [8] 326471 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] 326471 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [9] 326472 0
Infiltration and Extravasation: 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] 326472 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [10] 326473 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] 326473 0
Daily from IAC insertion until the time of first dressing change.
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
Secondary outcome [11] 326474 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] 326474 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [12] 326475 0
Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale .
Timepoint [12] 326475 0
At the time of IAC removal.
Secondary outcome [13] 342527 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] 342527 0
Daily from IAC insertion until the time of IAC removal.
Secondary outcome [14] 348824 0
Uncontrolled bleeding: Defined as continuous blood loss (ooze) resulting in device removal and/or replacement.
Timepoint [14] 348824 0
Daily from IAC insertion until 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 16 years or above
5, Patients admitted to the Intensive Care Unit
Minimum age
16 Years
Maximum age
No limit
Gender
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 (or their representative) will be approached for written informed consent by the RN or inserter. 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 ratio between the two 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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6422 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 8995 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 17497 0
4032 - Chermside
Recruitment postcode(s) [2] 13963 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 294239 0
University
Name [1] 294239 0
Griffith University
Address [1] 294239 0
Menzies Health Institute Queensland
Griffith University
179 Kessels Road
Nathan, QLD, 4111
Country [1] 294239 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Menzies Health Institute Queensland
Griffith University
170 Kessels Road
Nathan, QLD, 4111
Country
Australia
Secondary sponsor category [1] 293068 0
None
Name [1] 293068 0
Not applicable
Address [1] 293068 0
Not applicable
Country [1] 293068 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295662 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 295662 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] 295662 0
Australia
Date submitted for ethics approval [1] 295662 0
19/04/2016
Approval date [1] 295662 0
26/05/2016
Ethics approval number [1] 295662 0
HREC/16/QRCH/75
Ethics committee name [2] 295663 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 295663 0
Office for Research
Bray Centre, Nathan Campus
170 Kessels Rd
Nathan, QLD, 4111
Ethics committee country [2] 295663 0
Australia
Date submitted for ethics approval [2] 295663 0
26/05/2016
Approval date [2] 295663 0
17/06/2016
Ethics approval number [2] 295663 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, phlebitis, occlusion, and dislodgement; (ii) compare usual care dressings with a novel method; (iii) evaluate the acceptability of these devices to patients and health professionals; and (iv) study adverse effect profiles.

You may be eligible to participate in this trial if you are an intensive care patient over the age of 16 and are having an intra-arterial catheter inserted as part of your 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 two IAC securement options. These will be either (i) the standard simple polyurethane dressing; or (ii) an integrated securement device and simple polyurethane dressing combined into a single device

The allocated dressing will be applied from device insertion until the time of device removal. Participants 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68058 0
Prof Claire Rickard
Address 68058 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68058 0
Australia
Phone 68058 0
+61 7 3735 4886
Fax 68058 0
Email 68058 0
c.rickard@griffith.edu.au
Contact person for public queries
Name 68059 0
Ms Amanda Ullman
Address 68059 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68059 0
Australia
Phone 68059 0
+61737357854
Fax 68059 0
Email 68059 0
a.ullman@griffith.edu.au
Contact person for scientific queries
Name 68060 0
Ms Amanda Ullman
Address 68060 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68060 0
Australia
Phone 68060 0
+61737357854
Fax 68060 0
Email 68060 0
a.ullman@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary