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Trial registered on ANZCTR


Registration number
ACTRN12619001026112
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
18/07/2019
Date last updated
25/01/2022
Date data sharing statement initially provided
18/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.
Scientific title
Paediatric Reduction in Emergency Cannula Accidental REmoval (PRECARE) Trial: Randomised controlled trial of an integrated securement device or tissue adhesive versus standard care (bordered polyurethane) dressings on peripheral intravenous cannula failure in paediatric patients.
Secondary ID [1] 298021 0
Nil
Universal Trial Number (UTN)
U1111-1232-0316
Trial acronym
PRECARE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral IntraVenous Cannula failure prior to completion of therapy 312473 0
Condition category
Condition code
Public Health 311020 311020 0 0
Health service research
Emergency medicine 311336 311336 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study will have a Peripheral Intravenous Cannula (PIVC) inserted in the emergency department by paediatric specialised Doctors and Nurses. Consented patients will have their PIVC dressed and secured with one of the three following randomly assigned options:

1) Standard care (CONTROL): Bordered polyurethane dressing (BPU) (Tegaderm Advanced®; 3M) – standard care most commonly used at Logan and Ipswich hospital Emergency Department

2) Advanced dressing: SorbaView SHIELD® (Centurion Medical Products)

3) Advanced dressing with tissue adhesive: SorbaView SHIELD® (Centurion Medical Products) and Tissue Adhesive (SecurePortIV™ (Adhezion Biomedical®)

Patients will be monitored daily for a maximum of 4 weeks 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 the PIVC.
Intervention code [1] 314250 0
Prevention
Intervention code [2] 314251 0
Treatment: Devices
Comparator / control treatment
Control group patients will receive standard care (defined as most common practice among clinicians at Logan and Ipswich hospital Emergency Departments). Standard care is defined as a Bordered polyurethane dressing (BPU) (Tegaderm Advanced®; 3M) applied to secure a PIVC insertion until device removal.
Control group
Active

Outcomes
Primary outcome [1] 319815 0
The primary aim of this study is to test PIVC failure: composite of any unplanned PIVC removal, where reinsertion is required. This includes complete dislodgement, infection, occlusion (PIVC cannot be flushed, or leakage occurs when fluid infused), infiltration (fluid perfusion into the surrounding tissue), phlebitis (2 or more of pain, redness, swelling). A composite measure, that will increase trial precision and efficiency, was chosen since PIVC failure is the outcome of importance to patients, with poor securement leading to the same endpoint. This will be measured through iEMR records, FLACC and FACES pain tool and documented nursing observations.
Timepoint [1] 319815 0
On removal of the PIVC as decided by the treating doctor as no longer required for up to 4 weeks or at the time of loss of PIVC from complications such as accidental removal or occlusion (as appropriate).
Secondary outcome [1] 369591 0
As a composite secondary outcome, PIVC complications: as defined previously (dislodgement, occlusion, infiltration, infection, phlebitis) will all be treated as one. An analysis of the individual causes of PIVC complications will also be examined by review of medical records, Pain face and numeric rating scales, and documented paediatric specific staff observations.
Timepoint [1] 369591 0
Whilst the PIVC is in-situ and on device removal
Secondary outcome [2] 369592 0
PIVC longevity: time from PIVC insertion to removal due to completion of treatment or complication that will be measured by the cannula log used on iEMR electronic patient records.
Timepoint [2] 369592 0
On removal of the PIVC as decided by the treating doctor as no longer required or at the time of loss of PIVC from complications such as accidental removal or occlusion (as appropriate).
Secondary outcome [3] 369593 0
Pain and distress: associated with PIVC and dressing removal, measured using validated FLACC and Wong - baker FACES scales appropriate to patient age and development.
Timepoint [3] 369593 0
Observations will be documented whilst the PIVC is in-situ looking for signs of pain and distress and on device removal a final pain and distress score will be documented.
Secondary outcome [4] 369594 0
Healthcare costs will be measured by mapping the resource pathways through estimating costs for the staff time and equipment associated with insertion, management, removal and complications during PIVC treatment. This will be assessed via cost data linkage to medical records.
Timepoint [4] 369594 0
All participants will cease trial participation at PIVC removal.
Secondary outcome [5] 369595 0
Staff satisfaction: measured on a scale of 0 (min.) to 10 (max.)
Timepoint [5] 369595 0
On device removal.

Eligibility
Key inclusion criteria
• Aged greater than 6 months to 8 years inclusive
• Anticipated requirement for a PIVC for more than 24hours
• Hospital admission to the inpatient unit requiring an expected stay of 24 hours or more
Minimum age
6 Months
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known allergy to study products
• Non-English-speaking family without interpreters
• Has a currently identified blood stream infection
• Current skin tear or at high risk of tear
• Previous participation in the 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)
Patients presenting to ED and requiring insertion of PIVC will be screened by research nurses (ReN) and trained clinicians (research champions) for eligibility, using pre-determined inclusion / exclusion criteria. ReN and research champions will discuss suitability with the managing clinician and PIVC inserter, prior to approaching family for informed consent. Written informed consent by an appropriate legal guardian will be obtained prior to intervention, at time of enrolment. Due to workflow pressures, allocation concealment will be maintained through sequentially numbered, sealed, opaque envelopes, provided to sites and indicate the allocated treatment arm upon opening. This procedure will be regularly audited by the ReN and CIA. It is not possible to blind the intervention or outcome assessors. The dressings must be monitored by clinical staff and they are visibly different. The statistician undertaking the data analysis will be blinded to study group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer based randomisation will be used to allocate patients in a 1:1:1 ratio with randomly varied block sizes stratified by hospital (Logan vs Ipswich). ReN or clinician will select the lowest numbered study pack (next pack system) from study baskets in each ED. .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cleaned and de-identified study observations will be transferred to Stata 15 for data management and analysis by AI Mihala. Participant and clinical characteristics, including outcomes will be presented in tables using descriptive statistics, appropriate to data characteristics. Chi-squared statistics will be used to compare the incidence of outcomes between study groups. Incidence Rates will be calculated using the total dwell times by groups. Kaplan-Meier curve will display survival (of PIVCs) over time by study groups. The relative risk (hazard ratio, HR) of failure will be computed with Cox regression; confounding by and interaction with patient/clinical characteristics will be investigated during multivariable Cox regression model building. Age may be entered into the models as continuous or categorical (age groups, i.e. less than or equal to 12 months old) variable, depending on univariable results. Missing values will not be imputed. Results will be evaluated using clinical and statistical significance (p less than or equal to 0.025 one-sided). No interim analysis will be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/08/2019
Actual
11/02/2020
Date of last participant enrolment
Anticipated
1/06/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
506
Accrual to date
390
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13642 0
Logan Hospital - Meadowbrook
Recruitment hospital [2] 13643 0
Ipswich Hospital - Ipswich
Recruitment postcode(s) [1] 26314 0
4131 - Meadowbrook
Recruitment postcode(s) [2] 26315 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 302546 0
Charities/Societies/Foundations
Name [1] 302546 0
Emergency Medicine Foudation
Country [1] 302546 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus
170 Kessels Road,
Nathan QLD, 4111
Country
Australia
Secondary sponsor category [1] 302455 0
Hospital
Name [1] 302455 0
Logan Hospital Metro South HHS
Address [1] 302455 0
Cnr Loganlea and Armstrong Rd
Meadowbrook QLD 4131
Country [1] 302455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303191 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303191 0
Ethics committee country [1] 303191 0
Australia
Date submitted for ethics approval [1] 303191 0
08/01/2019
Approval date [1] 303191 0
27/03/2019
Ethics approval number [1] 303191 0
HREC/2019/QCHQ/45567
Ethics committee name [2] 303192 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 303192 0
Ethics committee country [2] 303192 0
Australia
Date submitted for ethics approval [2] 303192 0
04/04/2019
Approval date [2] 303192 0
15/04/2019
Ethics approval number [2] 303192 0
2019/284
Ethics committee name [3] 303193 0
University of Southern Queensland Human Research Ethics Committee
Ethics committee address [3] 303193 0
Ethics committee country [3] 303193 0
Australia
Date submitted for ethics approval [3] 303193 0
Approval date [3] 303193 0
Ethics approval number [3] 303193 0

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

Contacts
Principal investigator
Name 92806 0
Ms Brooke Charters
Address 92806 0
Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
Country 92806 0
Australia
Phone 92806 0
+61 07 32998899
Fax 92806 0
Email 92806 0
brooke.charters@health.qld.gov.au
Contact person for public queries
Name 92807 0
Brooke Charters
Address 92807 0
Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
Country 92807 0
Australia
Phone 92807 0
+61 07 32998899
Fax 92807 0
Email 92807 0
brooke.charters@health.qld.gov.au
Contact person for scientific queries
Name 92808 0
Brooke Charters
Address 92808 0
Logan Hospital
Emergency Department
Cnr Loganlea and Armstrong Rds
Meadowbrook, QLD 4131
Country 92808 0
Australia
Phone 92808 0
+61 07 32998899
Fax 92808 0
Email 92808 0
brooke.charters@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.