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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
12/10/2022
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 : greater than 1cm movement in the catheter tip position at any point during CVAD dwell including both partial and total dislodgement assessed via direct observation and medical record review.
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
Secondary outcome [7] 407881 0
Partial (any post-insertion change in the documented external catheter length or diagnosed using internal imaging); assessed via direct observation and medical record review.
Timepoint [7] 407881 0
From time of insertion to catheter dislodgement or when the catheter is removed
Secondary outcome [8] 407882 0
Total dislodgement: total (CVAD completely leaves the vein or must be replaced because CVAD tip is no longer in the superior vena cava and non-peripherally compatible medication is prescribed; diagnosed by x-Ray/leakage from site on injection/clinician diagnosis). Assessed via direct observation and medical record review.
Timepoint [8] 407882 0
From time of insertion to catheter dislodgement or when the catheter is removed
Secondary outcome [9] 407883 0
Catheter related adverse events: defined as catheter associated-thrombosis (confirmed via imaging), extravasation, occlusion (complete), CLABSI and local infection. Assessed via direct observation and medical record review.
Timepoint [9] 407883 0
From time of insertion to catheter dislodgement or when the catheter is removed
Secondary outcome [10] 407884 0
Central intravenous therapy disruption, defined as: disruption to intravenous therapy that cannot be administered safely without central access. Assessed via direct observation and medical record review.
Timepoint [10] 407884 0
From time of insertion to catheter dislodgement or when the catheter is removed
Secondary outcome [11] 407885 0
Patient and or parent acceptability and satisfaction during dressing change as indicated on an 11 point (0-10) numerical rating scale of increasing satisfaction as reported on study completion. This measure is a composite of patient or parent acceptability and satisfaction with dressing change
Timepoint [11] 407885 0
as reported on study completion and removal of securement product
Secondary outcome [12] 407886 0
Staff report of difficulty of removal of securement device as rated on an 11 point (0-10) numerical rating scale of increasing difficultly on removal as measured by verbal report
Timepoint [12] 407886 0
On removal of device

Eligibility
Key inclusion criteria
1. Neonate to 18 years of age
2. Patients requiring PICC insertion (equal to or greater than a 3 fr) and/or
3. Insertion of tunnelled non-cuffed CVC (equal to or greater than a 3 fr)
4. Informed consent to participate
Minimum age
No limit
Maximum age
18 Years
Sex
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
5. Children with an indeterminate length of treatment (likely less than 2 weeks)
6. Known allergy to any of the study products.

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
The internal feasibility study (n=60) will assess feasibility of the protocol. Feasibility data informed larger trial sample size calculation. Feasibility data will be reported descriptively.

Characteristics of groups at baseline will be assessed using demographic, social and clinical parameters, and will be reported using descriptive statistics. Means and standard deviations will be used to report normally distributed continuous data, medians and interquartile ranges will be used for interval data that could not be approximated with a normal distribution. Categorical data will be reported as frequency (percentage).

Costs from a health sector perspective will be estimated as the sum product of unit costs and quantity of resources for each group including costs associated with CASI. Resources will include securement products, affiliated consumables and staff time required for dressing changes. Estimates of staff time will be based on a convenience sub-set of the sample (n= 30 participants/group). Resource utilisation and cost of subsequent healthcare resource utilisation due to CASI and any identified adverse events, will be explored using a modelling approach based on treatment guidelines, expert opinion and published cost estimates. Resource utilisation, including staff time, will be reported descriptively. Mean and standard deviation for total cost estimates for each securement group will be reported along with sub-group cost estimates defined by PICC or Tunnelled CVC. For this trial, statistically significant differences in total costs will be explored using a generalised linear model with group allocation as the primary explanatory variable. A priori, cost data are assumed to be non-normally distributed, and a generalised linear model with log link, gamma family will be used. Alternative family and log link specifications of the statistical model will be explored with final model specification determined by comparison of AIC and BIC estimates.

Incidence outcomes will be compared between groups using Poisson regression models, with the natural logarithm of time-at-risk included as an offset where appropriate. Interval outcomes will be compared using linear regression models. Categorical outcomes will be compared using logistic regression models, Time-to-event outcomes will be compared using semi-parametric methods such as Cox proportional hazards regression. Dislodgement rates will be calculated per 1,000 days to account for varied dwell times. Data will be analysed on an intention to treat basis with patient the unit of analysis. Analysis will be undertaken using both an intention to treat population, to test the efficacy of the intervention regime, and a per-protocol population, to test the efficacy of the intervention receipt. A P- value of p<0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2020
Actual
11/08/2020
Date of last participant enrolment
Anticipated
Actual
28/06/2022
Date of last data collection
Anticipated
Actual
18/08/2022
Sample size
Target
310
Accrual to date
Final
310
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
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. We have completed an inbuilt feasibility study (n=60) and are continuing on to a powered RCT.
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
[email protected]
Contact person for public queries
Name 100491 0
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
[email protected]
Contact person for scientific queries
Name 100492 0
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
[email protected]

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 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
Dimensions AIDART 3: A pragmatic stepped wedge cluster randomised trial of ultrasound guidance to reducing multiple PIVC insertions in hospitalised patients2023https://doi.org/10.1016/j.idh.2023.09.021
N.B. These documents automatically identified may not have been verified by the study sponsor.