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Trial registered on ANZCTR


Registration number
ACTRN12620000783921
Ethics application status
Approved
Date submitted
21/05/2020
Date registered
3/08/2020
Date last updated
3/08/2020
Date data sharing statement initially provided
3/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Securing Central venous catheters to prevent catheter Dislodgment in children: the SECURED trial
Scientific title
Securing Central venous catheters using a subcutaneously anchored securement system to prevent catheter Dislodgment in children: the SECURED trial
Secondary ID [1] 300658 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-4058
Trial acronym
SECURED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Venous Catheters 316450 0
Securement devices 316451 0
Altered Skin Integrity 316453 0
Catheter Dislodgement 316454 0
Peripherally inserted central catheter 316456 0
Condition category
Condition code
Anaesthesiology 314701 314701 0 0
Other anaesthesiology
Skin 314702 314702 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SecurAcath Registered Trademark is a subcutaneously anchored securement system (SASS) that has small, blunt, nitinol, flexible feet placed just beneath the skin which act to stabilize the peripherally inserted central catheter (PICC) or Central venous catheters (CVC) at the point of insertion or catheter exit.
The inserting clinician will place the SASS, this clinician will be an advanced practitioner with anaesthetic and vascular access skills (e.g. Nurse practitioner, anaesthetist). The intervention will be delivered in clinical practice, face-to-face. The intervention will be delivered on catheter insertion, at a single time point and will remain in place for the duration of the catheter. The intervention will occur at the hospital site.


If dislodgement occurs SASS will be removed with the device, if required a new device will be inserted based on treating clinician preference.
Intervention fidelity will be monitored and promoted by the clinician research nurse using medical notes and through participation in the insertion procedure.
It is anticipated the study will run for 52 weeks as detailed in the dates section


Intervention code [1] 316986 0
Treatment: Devices
Comparator / control treatment
Sutureless securement devices (SSDs) that have large adhesive padded footplates with plastic locking clasps with a transparent dressing placed over the point of insertion and SSD.
The inserting clinician will place the SSD, this clinician will be an advanced practitioner with anaesthetic and vascular access skills (e.g. Nurse practitioner, anaesthetist). The device will be delivered in clinical practice, face-to-face. The intervention will be delivered on catheter insertion, and be replaced weekly for the duration of the catheter by the treating clinician. The intervention will occur at the hospital site.
Control group
Active

Outcomes
Primary outcome [1] 323040 0
Feasibility of a full-scale efficacy trial will be established by a demonstration that:
a) Greater than 75% of patients screened are eligible
b) Greater than 80% of eligible participants agree to enrol
c) Greater than 80% of participants in the intervention groups receive their allocated treatment
d) Less than 5% of participants are lost to follow up
e) There are less than 5% missing data
f) Parents and healthcare staff report > 80% satisfaction and acceptability with the study intervention.

Feasibility outcomes will be assessed using a participant screening log and likert scales to determine parent and staff satisfaction.
Timepoint [1] 323040 0
Assessed when treatment is complete or the catheter fails and the device is no longer required or insitu.

Assessed until trial end (maximum 3 months post) or device failure or removal.
Primary outcome [2] 323041 0
Catheter dislodgement (total or partial) assessed via direct observation and medical record review.
Defined as:
Partial: any post-insertion change in the documented external catheter length
Total: CVAD completely leaves the vein or must be removed because CVAD tip is no longer in the superior vena cava (diagnosed by x-Ray/leakage from site on injection/clinician diagnosis)
Timepoint [2] 323041 0
From time of insertion to catheter dislodgement when the catheter is removed
Secondary outcome [1] 380602 0
Compare rates of central venous access device-associated skin injury (CASI) with SASS compared to SSD. Assessed via direct observation and medical record review.
Timepoint [1] 380602 0
From time of insertion to catheter removal, when the catheter fails or is removed as no longer required or treatment has been completed.
Secondary outcome [2] 380603 0
Compare dwell time of devices secured with SASS compared to SSD. Assessed via direct observation and medical record review.
Timepoint [2] 380603 0
From time of insertion to removal of device, in hours. This can be removal for failure, accidental removal or intentional removal as treatment has been completed and the device is no longer required.
Secondary outcome [3] 380604 0
Patient and or parent acceptability and satisfaction of SSD and SASS for catheter securement and experience during dressing change; as indicated on 0-10 Likert scale of increasing satisfaction
Timepoint [3] 380604 0
From time of insertion to removal of device, in hours. With a dressing change until device removal
Secondary outcome [4] 380605 0
Staff satisfaction during dressing change; as indicated on 0-10 Likert scale of increasing satisfaction
Timepoint [4] 380605 0
From insertion of device to removal of device, in hours. With a dressing change until device removal
Secondary outcome [5] 380606 0
Staff satisfaction with ease of application of securement device as rated on 0-10 Likert scale of increasing satisfaction
Timepoint [5] 380606 0
On insertion, following application of device.
Secondary outcome [6] 380607 0
Compare the healthcare costs between securement with SASS and SSD/. Including Cost and number of products used, cost of treating complications, staff time for device insertion. Assessed using hospital finance records and national health data.
Timepoint [6] 380607 0
At the end of trial, end of recruitment, anticipated 52 weeks

Eligibility
Key inclusion criteria
1. Neonate to 18 years of age
2. Patients requiring PICC insertion presenting with altered skin integrity and/or
3. Insertion of tunnelled non-cuffed CVC
4. Informed consent to participate
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Non-English speakers without an interpreter
2. Children under care of department of communities or without a legal guardian
3. Patient receiving end-of-life care
4. Previous enrolment in this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Web-based randomisation service. Allocation was concealed using a web based central randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be 1:1 to the SSD or SASS group, with randomly varied blocks of sizes 6 and 8 (1:1 ratio) and stratified by altered skin integrity or tunnelled CVC. Allocation concealment will be ensured until time of device insertion.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For this feasibility study (n=60), the recruitment target is 30 participants per group. The study is not powered to detect statistical significance, but rather to assess the feasibility of this protocol for a larger definitive study and provide baseline estimates for the sample size calculations. This sample size has been shown to be adequate for the purposes of feasibility assessment. We will recruit 1-2 patients/week over 52 weeks from QCH and PCH inpatient units, referred to vascular access service by various medical and/or surgical clinicians, and our extensive clinical trial expertise in vascular access informs our estimate is achievable.

Recruitment
Recruitment status
Not yet recruiting
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,WA
Recruitment hospital [1] 15993 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 15995 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 29492 0
4101 - South Brisbane
Recruitment postcode(s) [2] 29493 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305082 0
Hospital
Name [1] 305082 0
In kind support including Queensland Children Hospital staff time and provision of devices
Address [1] 305082 0
Queensland Children's Hospital
501 Stanley Street
South Brisbane, QLD, 4101
Country [1] 305082 0
Australia
Primary sponsor type
Hospital
Name
Queenland Children's Hospital
Address
Queensland Children's Hospital
501 Stanley Street
South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 305455 0
Hospital
Name [1] 305455 0
Perth Children's Hospital
Address [1] 305455 0
Perth Children's Hospital
15 Hospital Avenue
Nedlands, WA, 6009
Country [1] 305455 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305473 0
Childrens Health Queensland Human Research Ethics Committee
Ethics committee address [1] 305473 0
Human Research Ethics Committee
Level 7, Centre for Children's Health Research
Queensland Children's Hospital Health Precinct
62 Graham Street
South Brisbane, QLD 4101
Ethics committee country [1] 305473 0
Australia
Date submitted for ethics approval [1] 305473 0
01/04/2020
Approval date [1] 305473 0
24/04/2020
Ethics approval number [1] 305473 0
HREC/20/QCHQ/62034

Summary
Brief summary
The Queensland Children’s Hospital and Perth Children’s Hospital have identified a need to determine if SASS is superior to SSD for PICC and tunnelled CVC securement for; a) patients requiring PICC that have compromised skin integrity and b) all patients requiring insertion of tunnelled CVC. The results of this study will inform paediatric healthcare practice, provide reliable estimates of the comparative effect of SASS, and inform the feasibility of conducting a larger, definitive trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100490 0
Ms Jessica Schults
Address 100490 0
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100490 0
Australia
Phone 100490 0
+61 7 3069 7563
Fax 100490 0
Email 100490 0
Jessica.Schults@health.qld.gov.au
Contact person for public queries
Name 100491 0
Ms Jessica Schults
Address 100491 0
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100491 0
Australia
Phone 100491 0
+61 7 3069 7563
Fax 100491 0
Email 100491 0
Jessica.Schults@health.qld.gov.au
Contact person for scientific queries
Name 100492 0
Ms Jessica Schults
Address 100492 0
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100492 0
Australia
Phone 100492 0
+61 7 3069 7563
Fax 100492 0
Email 100492 0
Jessica.Schults@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
Participant data is confidential
What supporting documents are/will be available?
No other documents available
Summary results
No Results