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Trial registered on ANZCTR


Registration number
ACTRN12621000206820
Ethics application status
Approved
Date submitted
18/12/2020
Date registered
26/02/2021
Date last updated
26/02/2021
Date data sharing statement initially provided
26/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Efficacy of Peripheral intravenous catheter (PIVC) insertion using Imaging technology compared to Combined palpation and visualization for first-time insertion success. The EPIC randomised controlled trial.
Scientific title
A parallel-group, superiority randomised control trial (RCT) conducted in children aged 0-18 years of age will investigate the efficacy of ultrasound guided PIVC insertion compared to landmark technique to increase first attempt PIVC insertion success.
Secondary ID [1] 302712 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
EPIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral intravenous catheter insertion failure 320055 0
Condition category
Condition code
Public Health 317982 317982 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound-guided PIVC insertion is the use of ultrasound to locate and select an appropriate vein, with the PIVC inserted under direct ultrasound visualization by advancing the needle into the vein whilst moving the ultrasound probe in the direction of needle advancement. The procedure takes approximately 10 minutes and is performed by specialist practitioners such as vascular access specialists, anaesthetists and paediatric registrars trained in this procedure. Protocol adherence will be monitored by the nurse assisting the procedure.
Intervention code [1] 319011 0
Treatment: Devices
Comparator / control treatment
Traditional peripheral intravenous catheter insertion utilising a combination of palpation and visualisation of veins.
Control group
Active

Outcomes
Primary outcome [1] 325636 0
First time insertion success: The number of PIVCs successfully inserted on first needle puncture as evidenced by blood flashback and ability to infuse 2-10mL (age appropriate) 0.9% sodium chloride without signs of swelling or pain at the insertion site.
This data will be collected on insertion and verified in the patient electronic medical record.
Timepoint [1] 325636 0
At conclusion of study participation
Secondary outcome [1] 388617 0
Total number of PIVC insertion attempts (skin punctures) to successfully insert PIVC
This data will be collected on insertion and verified in patient electronic medical record. This outcome will be assessed for each participant
Timepoint [1] 388617 0
At successful insertion of PIVC or abandonment of the procedure. The procedure will be abandoned once escalated to the most experienced inserter and 6 failed attempts.
Secondary outcome [2] 388618 0
Total PIVC insertion failure: Proportion of PIVCs that are unable to be inserted and require alternative therapy as indicated by audit of study database
Timepoint [2] 388618 0
At successful insertion of PIVC or at conclusion of study participation
Secondary outcome [3] 388619 0
Time to insert device: from start of procedure (application of tourniquet), to successful insertion (instillation of 2-10mL (age appropriate) 0.9% NaCl without any swelling at the site and application of dressing). This will be documented at time of insertion by nurse assisting and documented in patient medical record
Timepoint [3] 388619 0
At successful insertion of PIVC or conclusion of study participation
Secondary outcome [4] 388621 0
Time to initiation of treatment from when treatment is prescribed to first intravenous dose as documented in patient medical record.
Timepoint [4] 388621 0
Administration of first dose of IV medication following device insertion.
Secondary outcome [5] 388622 0
Post-insertion failure: PIVC dysfunction resulting in device no longer being suitable for treatment. A composite measure of causes of post-insertion failure including pain, infiltration/extravasation, blockage/occlusion (with or without leakage), phlebitis (pain, erythema), thrombosis (radiologically confirmed), dislodgement (complete or partial) or infection (laboratory confirmed local or primary bloodstream infection). This will be collected daily on purpose built data extraction form and obtained from patient medical records.
Timepoint [5] 388622 0
Collected at 48 hours following device removal
Secondary outcome [6] 388623 0
Device dwell-time (time from insertion to removal, in hours) as recorded on purpose built data extraction form and patient medical records.
Timepoint [6] 388623 0
Collected at device removal
Secondary outcome [7] 388624 0
Number of additional devices required to complete treatment. This will be collected on purpose built data extraction form and documented in patient medical records..
Timepoint [7] 388624 0
Collected at completion of intravenous therapy or at study completion.
Secondary outcome [8] 388625 0
Health care costs: Associated with insertion procedures including the cost of subsequent sequalae (eg. cost and number of products used, cost of treating complications, staff time for device insertion)
Timepoint [8] 388625 0
Collected at completion of intravenous therapy or treatment OR at resolution of complications that may arise. As recorded on purpose built data extraction form and in patient medical records.
Secondary outcome [9] 388626 0
Patient or parent reported satisfaction regarding insertion procedure (measured immediately following insertion using a 0-10 verbal rating scale)
Timepoint [9] 388626 0
Immediately following the successful insertion of PIVC or at conclusion of study participation.
Secondary outcome [10] 389950 0
Number of times it was not possible to insert PIVC using randomised insertion technique, however use of alternate technique resulted in successful PIVC insertion as documented in data extraction form and patient medical records.
Timepoint [10] 389950 0
At successful insertion of PIVC or at conclusion of study participation.
Secondary outcome [11] 390828 0
Pain, Assess using visual analog scale (0-10), documented on purpose built data extraction form and documented in patient medical record.
Timepoint [11] 390828 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [12] 390831 0
infiltration/extravasation, movement of fluids in to the surrounding tissues will be assessed using visual assessment, documented in purpose built data extraction form and patient medical records
Timepoint [12] 390831 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [13] 390832 0
blockage/occlusion (with or without leakage), unable to inject or aspirate from the device. This will be collected daily on purpose built data extraction form and obtained from patient medical records.
Timepoint [13] 390832 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [14] 390833 0
phlebitis (defined as 2 or more of pain, redness or swelling), This will be obtained from patient medical records and collected on purpose built data extraction form..
Timepoint [14] 390833 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [15] 390834 0
Dislodgement (complete or partial), As determined by change in external device length at insertion site (inner catheter visible), however remains in the vein, Total - device completely leaves the vein. As documented in patient medical record or purpose built data extraction form
Timepoint [15] 390834 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [16] 390835 0
Infection (laboratory confirmed local or primary bloodstream infection) . A laboratory confirmed blood stream infection (BSI) that is not secondary to an infection at another body site, with device in place for >2 calendar days on the day of the BSI (day of device placement being Day 1) and the device was in place on the date of the event or the day before, when all elements of Laboratory confirmed BSI, were first present together (see CDC NHSN for full criteria) confirmed by an infectious disease specialist using de-identified clinical and microbiological data.
Timepoint [16] 390835 0
Data collected daily by the clinical research nurse until removal of PIVC

Eligibility
Key inclusion criteria
1. Between 0- 365 days and 18 years of age
2. The treating team have indicated that the patient will require intravenous therapy
3. Informed consent to participate
4. Conscious for insertion of PIVC
5. Inpatient at Queensland Children's Hospital
Minimum age
0 Days
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
5. Previously documented high-risk Difficult Intravenous Access (DIVA)

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)
central web based randomisation service. The inserter will be unaware of randomised technique until point of insertion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised using a central, web-based randomisation service hosted by Griffith University.
Patient level randomisation will be 1:1 to the USG PIVC or Standard care PIVC group, with randomly varied blocks of sizes 4 and 6 (1:1 ratio) and stratified by DIVA assessment (low, medium and high)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will summarise patient characteristics using appropriate
measures of spread and locations; and comparisons between study arms on first attempt
insertion success via logistic regression with effect estimates presented as odds ratios and
95% CI. An alpha value of p = or less than 0.05 will be considered significant. Baseline variables and secondary outcomes will be compared between treatment groups for clinically significant differences. For time-to-event outcomes, Kaplan-Meier curves will be drawn. Cox regression will assess the effect of patient and treatment differences as well as group comparisons of post-insertion device failure (p equal or less than 0.05 significant).

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
Recruitment hospital [1] 17971 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 31846 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307143 0
Charities/Societies/Foundations
Name [1] 307143 0
Children's Hospital Foundation
Address [1] 307143 0
494 Stanley St
South Brisbane
QLD 4101
Country [1] 307143 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Nathan campus
Building N48 Room 0.12
170 Kessels Road, NATHAN, QLD, 4111
Country
Australia
Secondary sponsor category [1] 308071 0
None
Name [1] 308071 0
Address [1] 308071 0
Country [1] 308071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307256 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 307256 0
Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 307256 0
Australia
Date submitted for ethics approval [1] 307256 0
23/11/2020
Approval date [1] 307256 0
16/12/2020
Ethics approval number [1] 307256 0
HREC/20/QCHQ/61248

Summary
Brief summary
Most children receiving inpatient care at the Queensland Children's Hospital will require the insertion of a PIVC. Two thirds of healthcare consumers describe peripheral intravenous catheter (PIVC) insertion, as the ‘worst’ thing to happen during hospital admission, describing it as painful, frustrating and stressful. Despite their importance, PIVCs can be hard to insert with unacceptably high rates of first attempt insertion failure reported.
This study aims to determine the efficacy of ultrasound guided PIVC insertion compared to landmark technique to increase first time insertion success in children aged <18 years.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 106586 0
Ms Tricia Kleidon
Address 106586 0
Department of Anaesthesia and Pain Management
Level 7f, Queensland Children’s Hospital, Queensland
501 Stanley St, South Brisbane, Qld 4101

Country 106586 0
Australia
Phone 106586 0
+61 07 3068 1135
Fax 106586 0
Email 106586 0
tricia.kleidon@health.qld.gov.au
Contact person for public queries
Name 106587 0
Ms Tricia Kleidon
Address 106587 0
Department of Anaesthesia and Pain Management
Level 7f, Queensland Children’s Hospital, Queensland
501 Stanley St, South Brisbane, Qld 4101

Country 106587 0
Australia
Phone 106587 0
+61 07 3068 1135
Fax 106587 0
Email 106587 0
tricia.kleidon@health.qld.gov.au
Contact person for scientific queries
Name 106588 0
A/Prof Amanda Ullman
Address 106588 0
Menzies Health Institute Queensland School of Nursing and Midwifery
Griffith University
Nathan Campus
Health Sciences (N48) Room 2.20
170 Kessels Road, NATHAN, QLD, 4111
Country 106588 0
Australia
Phone 106588 0
+61 07 3735 6462
Fax 106588 0
Email 106588 0
a.ullman@griffith.edu.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