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Trial registered on ANZCTR


Registration number
ACTRN12616001073493
Ethics application status
Approved
Date submitted
5/08/2016
Date registered
10/08/2016
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Secure My Intravascular Line Effectively (SMILE): a pilot randomised controlled trial to evaluate an integrated securement device and tissue adhesive for peripheral intravenous catheters in paediatric patients
Scientific title
Randomised controlled trial of an integrated securement device (ISD) or tissue adhesive (TA) versus standard care (bordered polyurethane) dressings on intravascular catheter failure in paediatric patients
Secondary ID [1] 289861 0
Nil known
Universal Trial Number (UTN)
U1111-1186-1758
Trial acronym
The SMILE trial: Paediatrics
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous device failure prior to completion of therapy 299803 0
Condition category
Condition code
Public Health 299731 299731 0 0
Health service research
Infection 299732 299732 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have peripheral venous catheters (PVC) used in paediatric medical, cardiac and surgical departments. Consenting participants (consent achieved from legal guardian) will have their PVC secured with either the interventions or control dressing and securements. This dressing and securement will be applied by either the Research Nurse or the treating clinician (dependent upon who inserts the PVC).

Arm 1 (Control): Bordered Polyurethane Dressing. Bordered polyurethane dressings (BPUs) retain the central polyurethane component of standard polyurethane dressings with an added external adhesive border of foam or cloth fabric.

Arm 2 (Intervention): Integrated Securement Device. An Integrated Securement Device is a polyurethane dressing which combines both SP (simple polyurethane) and SD (securement device) 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 will also be applied.

The randomly allocated dressing will be applied at the time of PVC insertion until device removal. There will be daily checks of the PVC site and dressings/securements to monitor protocol adherence and assess for any complications.
Intervention code [1] 295543 0
Prevention
Intervention code [2] 295544 0
Treatment: Devices
Comparator / control treatment
Control group patients will have their peripheral venous catheters secured with a bordered polyurethane dressing (as per standard care) at the time of PVC insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 299188 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 peripheral intravenous 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). Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [1] 299188 0
Feasibility measures: On device removal or at the time of trial completion (whichever occurs first).
Primary outcome [2] 299189 0
All cause PVC failure A composite of infection (laboratory confirmed local or bloodstream infection), occlusion, dislodgement (complete or partial), phlebitis, infiltration or thrombosis (suspected or confirmed). This composite measure incorporates the multifocal path to the same endpoint; PVC 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] 299189 0
At the time of PVC removal.
Secondary outcome [1] 326456 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] 326456 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [2] 326457 0
Occlusion: Defined as the PVC will not infuse, or leakage occurs when fluid is infused.
Timepoint [2] 326457 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [3] 326458 0
Dislodgement (either partial or total):
Partial - Change in PVC 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.
Total - PVC 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] 326458 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [4] 326459 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] 326459 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [5] 326460 0
Thombosis (either suspected on confirmed):
Suspected - 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 PVC site. This will be assessed by a review of the patient's medical records (including ultrasound findings).
Timepoint [5] 326460 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [6] 326461 0
PVC 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] 326461 0
At the time of PVC removal.
Secondary outcome [7] 326462 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; maceration, itching, 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] 326462 0
Daily from PVC insertion until the time of PVC removal. If an adverse event occurs the patient will be monitored until the skin reaction has resolved.
Secondary outcome [8] 326463 0
Staff and patient acceptability of the intervention - assessed on a 0-10 Likert scale.
Timepoint [8] 326463 0
At the time of PVC removal.
Secondary outcome [9] 338254 0
Infiltration: Defined as pain, swelling and discomfort caused by IV fluids leaking into the tissues surrounding the PVC
Timepoint [9] 338254 0
Daily from PVC insertion until the time of PVC removal.
Secondary outcome [10] 342526 0
Adhesion: Is the dressing intact, lifting slightly or 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 [10] 342526 0
Daily from PVC insertion until the time of PVC removal.

Eligibility
Key inclusion criteria
1. Informed written consent
2. PVC in situ
3. PVC scheduled/expected use >24 hours
4. Patient aged 18 years or less.
5, Patient admitted to a Medical, Cardiac or Surgical ward
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. PVCs 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 PVCs (vascular access management service, medical registrars and anaesthetists). All eligible patient representatives 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)
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
All randomised patients will be analysed on an Intention to Treat (ITT) basis. The patient is the unit of measurement with one PVC per patient being analysed. 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
Completed
Date of first participant enrolment
Anticipated
3/10/2016
Actual
1/02/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
10/05/2018
Date of last data collection
Anticipated
13/04/2018
Actual
14/05/2018
Sample size
Target
330
Accrual to date
Final
330
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6421 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 13962 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 294237 0
Commercial sector/Industry
Name [1] 294237 0
Centurion Medical Products
Country [1] 294237 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] 293066 0
None
Name [1] 293066 0
Not applicable
Address [1] 293066 0
Not applicable
Country [1] 293066 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295659 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 295659 0
Ethics committee country [1] 295659 0
Australia
Date submitted for ethics approval [1] 295659 0
19/04/2016
Approval date [1] 295659 0
26/05/2016
Ethics approval number [1] 295659 0
HREC/16/QRCH/75

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68054 0
Prof Claire Rickard
Address 68054 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68054 0
Australia
Phone 68054 0
+61 7 3735 6460
Fax 68054 0
Email 68054 0
c.rickard@griffith.edu.au
Contact person for public queries
Name 68055 0
Amanda Ullman
Address 68055 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68055 0
Australia
Phone 68055 0
+61737357854
Fax 68055 0
Email 68055 0
a.ullman@griffith.edu.au
Contact person for scientific queries
Name 68056 0
Amanda Ullman
Address 68056 0
NHMRC Centre for Research Excellence in Nursing
Griffith University, Nathan Campus
170 Kessels Road
Nathan, QLD, 4111
Country 68056 0
Australia
Phone 68056 0
+61737357854
Fax 68056 0
Email 68056 0
a.ullman@griffith.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseSmile - Secure my intravenous line effectively: A pilot randomised controlled trial of peripheral intravenous catheter securement in paediatrics.2020https://dx.doi.org/10.1016/j.jtv.2020.03.006
N.B. These documents automatically identified may not have been verified by the study sponsor.