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Trial registered on ANZCTR


Registration number
ACTRN12616000985482
Ethics application status
Approved
Date submitted
18/07/2016
Date registered
27/07/2016
Date last updated
1/11/2017
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 in an adult intensive care population.
Scientific title
Factorial, superiority, pilot randomised controlled trial testing alternative (1) dressing (chlorhexidine impregnated disc) and (2) securement (integrated securement device) to prevent arterial catheter failure and catheter associated bloodstream infection in an adult intensive care population.
Secondary ID [1] 289698 0
None
Universal Trial Number (UTN)
Trial acronym
The SMILE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial device failure prior to completion of therapy 299513 0
Condition category
Condition code
Public Health 299490 299490 0 0
Health service research
Infection 299523 299523 0 0
Other infectious diseases

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

Arm 1 (Control): Simple polyurethane dressing (SP).

Arm 2: Securement device; simple polyurethane dressing and a chlorhexidine impregnated (CHG) disc.

Arm 3: Integrated securement device. Integrated securement devices (ISDs) are simple polyurethane dressings which combine both dressing and securement properties into one product.

Arm 4: Integrated securement device and a chlorhexidine impregnated disc.

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] 295325 0
Treatment: Devices
Intervention code [2] 295326 0
Prevention
Comparator / control treatment
Control group patients will have their arterial catheter secured with a simple polyurethane dressing (as per standard care) at the time of catheter insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 298967 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); and retention (less than 5% of enrolled patients lost to follow up).
Timepoint [1] 298967 0
At the time of trial completion.
Primary outcome [2] 298968 0
Securement Hypothesis: All cause IAL failure

A composite of infection (laboratory confirmed local or bloodstream infection), occlusion, dislodgement (complete or partial), phlebitis, or thrombosis. This composite measure incorporates the multifocal path to the same endpoint; IAL 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] 298968 0
At the time of IAL removal.
Primary outcome [3] 298969 0
Dressing Hypothesis: Catheter-associated bloodstream infection, as defined by CDC NHSN criteria.

This will be confirmed by a blinded infectious diseases specialist using de-identified clinical and microbiological data.
Timepoint [3] 298969 0
At the time of IAL removal.
Secondary outcome [1] 325774 0
Infection (laboratory confirmed local or bloodstream infection): PVC skin and tip samples for culture may be collected by RNs upon PVC 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] 325774 0
Whilst the IAL is insitu and on device removal
Secondary outcome [2] 325775 0
Occlusion: Defined as the IAL will not infuse, or leakage occurs when fluid is infused.
Timepoint [2] 325775 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [3] 325776 0
Dislodgement (partial or complete)
Partial - Change in IAL 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 - IAL completely leaves the vein. 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] 325776 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [4] 325777 0
Phlebitis: 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] 325777 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [5] 325779 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/venographic confirmed thrombosed vessel at the IAL site. This will be identified by a review of the patient's medical records (including ultrasound findings).
Timepoint [5] 325779 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [6] 325780 0
IAL 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 [6] 325780 0
At the time of IAL removal.
Secondary outcome [7] 325781 0
Safety and adverse events; Skin reactions related to dressings and securements will be monitored including itch; rash (raised or not raised); 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 [7] 325781 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [8] 325782 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 [8] 325782 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [9] 325783 0
IAL function loss: Clinical staff unable to assess blood pressure or sample blood. 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] 325783 0
Daily from IAL insertion until the time of IAL removal.
Secondary outcome [10] 325988 0
Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale .
Timepoint [10] 325988 0
At the time of IAL removal.

Eligibility
Key inclusion criteria
1. Informed written consent
2. IAL in situ
3. IAL scheduled/expected use >24 hours
4. Patient aged 16 years or above
5, Patients admitted (or being 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. IALs inserted through diseased, burned or scarred skin
4. Other types of vascular access devices
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 IALs (anaesthetists, intensive care nurses). 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 1:1:1:1 ratio between the four study groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Participants will be allocated to:
1. Standard care (no intervention): SP (no CHG disc)
2. One intervention: a. SP+CHG disc; or b. ISD (no CHG disc)
3. Both interventions: ISD+CHG disc.

Blinded microbiologist and infectious diseases physicians will assign infectious outcomes (including Primary Outcome (1) catheter-associated bloodstream infection).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All randomised patients will be analysed on an Intention to Treat (ITT) basis. The patient is the unit of measurement with one IAL per patient being analysed. For this pilot trial, we will test the feasibility of the statistical analysis that will be used in the definitive trial. Comparability of groups at baseline will be assessed using clinical parameters. Relative incidence rates of device failure per 100 devices and per 1,000 device days with 95% confidence intervals (CIs) will summarise the impact of each dressing regimen, and to test difference between groups. Kaplan-Meier survival curves (with log rank test) will compare device failure over time. Secondary endpoints including dwell-time, dislodgement, infection and safety will be compared between groups using parametric or nonparametric techniques as appropriate. In addition to group, multivariate regression (Cox) models will test the effect of patient and device variables associated with device failure e.g. insertion site, dwell time, length of stay, diagnostic group, age, sex, mobility, co-morbidities and IV medications. Data will be exported into PASW 22.0 (SPSS Inc, Chicago, IL). Prior to analysis, data cleaning of outlying figures, missing, and implausible data will be undertaken, and a random 5% sample of source data re-entered and checked. All attempts will be made to collect the primary endpoint. Missing data will be modelled for best- and worst-case outcomes to assess for effect on overall results. A per-protocol analysis will assess the effect of protocol violations. P values of <0.05 will be considered significant.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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] 6189 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 13623 0
4006 - Herston
Recruitment postcode(s) [2] 13624 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 294082 0
Commercial sector/Industry
Name [1] 294082 0
Centurion Medical Products
Address [1] 294082 0
100 Centurion Way
Williamston MI USA 48895

*Unrestricted donation to Griffith University
Country [1] 294082 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] 292912 0
None
Name [1] 292912 0
Not applicable
Address [1] 292912 0
Not applicable
Country [1] 292912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295497 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 295497 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] 295497 0
Australia
Date submitted for ethics approval [1] 295497 0
19/04/2016
Approval date [1] 295497 0
26/05/2016
Ethics approval number [1] 295497 0
HREC/16/QRCH/75
Ethics committee name [2] 295498 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 295498 0
Office for Research
Bray Centre, Nathan Campus
170 Kessels Rd
Nathan, QLD, 4111
Ethics committee country [2] 295498 0
Australia
Date submitted for ethics approval [2] 295498 0
26/05/2016
Approval date [2] 295498 0
17/06/2016
Ethics approval number [2] 295498 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 (IAL). 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 four IAL dressing/securement options. These will be either (i) the standard simple polyurethane dressing; (ii) the standard simple polyurethane dressing and a chlorhexidine impregnated disc; (iii) an integrated securement device and simple polyurethane dressing combined into a single device; (iv) or an integrated securement device and chlorhexidine impregnated disc.

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, device failures and infections. It is hoped that the findings of this trial will provide information on which IAL securements and dressings are most effective in preventing IAL failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67486 0
Prof Claire Rickard
Address 67486 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 67486 0
Australia
Phone 67486 0
+61 7 37356460
Fax 67486 0
+61 7 37355431
Email 67486 0
c.rickard@griffith.edu.au
Contact person for public queries
Name 67487 0
Ms Emily Larsen
Address 67487 0
Centre for Clinical Nursing (Research and Development Unit)
Level 2, Building 34
Royal Brisbane and Women's Hospital
Cnr Bowen Bridge Road & Butterfield Street
Herston, QLD, 4029
Country 67487 0
Australia
Phone 67487 0
+61 7 36468725
Fax 67487 0
Email 67487 0
emily.larsen@health.qld.gov.au
Contact person for scientific queries
Name 67488 0
Prof Claire Rickard
Address 67488 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 67488 0
Australia
Phone 67488 0
+61 7 37356460
Fax 67488 0
+61 7 37355431
Email 67488 0
c.rickard@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results