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Trial registered on ANZCTR


Registration number
ACTRN12620000724976
Ethics application status
Approved
Date submitted
27/04/2020
Date registered
7/07/2020
Date last updated
12/10/2022
Date data sharing statement initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Prolonged administration of Intravenous Medication through Midline compared to Standard peripheral intravenous cannula in children
Scientific title
Prolonged administration of Intravenous Medication through Midline compared to Standard peripheral intravenous cannula in children to reduce catheter failure.
Secondary ID [1] 300657 0
Nil Known
Universal Trial Number (UTN)
U1111-1252-2834
Trial acronym
PIMMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalised children requiring vascular access 316447 0
Condition category
Condition code
Anaesthesiology 314698 314698 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Midline Catheters (MC)
MC insertion will be performed by a nurse practitioner or medical officer with demonstrated competence, in a clinical procedure room, using ultrasound, and surgical aseptic non-touch technique. MCs will be Access Scientific PowerWandTM XL Midline Catheter – 3fr, 4fr, as chosen by the inserting practitioner, dependent upon vessel assessment and treatment requirements.


Midline Catheters and Peripheral Intravenous Catheters will be inserted by trained clinicians as per local policy. Local anaesthetic, both topical and or subcutaneous (Lignocaine Hydrochloride) will be provided for both groups depending on the preference of the treating clinicians and patient. Devices will be removed by clinical staff when clinically indicated.

Device Insertion
Midline Catheters
Midline Catheter insertion will be performed by a nurse practitioner or medical officer with demonstrated competence, in a clinical procedure room, using ultrasound, and surgical aseptic non-touch technique. MCs will be Access Scientific PowerWandTM XL Midline Catheter – 3 French , 4 French, as chosen by the inserting practitioner, dependent upon vessel assessment and treatment requirements.

Peripheral Intravenous Catheters
Peripheral Intravenous Catheter insertion will be performed by a registered nurse or medical officer with demonstrated competence, in a clinical procedure room, using landmark/palpation and/or ultrasound depending on inserter preference. Aseptic non-touch technique will be utilised for all insertions. Catheters will be BD Insyte ™ Autoguard ™ safety. Peripheral Intravenous Catheter size (24 Gauge, 22 Gauge, 20 Gauge etc) will be determined by the inserter, dependent on treatment size and vessel assessment.

Strategies to assess and monitor intervention fidelity will include the chart audits, patient visits and the presence of an investigator (where possible) during catheter insertion.
Intervention code [1] 316985 0
Treatment: Devices
Comparator / control treatment
Peripheral Intravenous Catheters
PIVC insertion will be performed by a registered nurse or medical officer with demonstrated competence, in a clinical procedure room, using landmark/palpation and/or ultrasound depending on inserter preference. Aseptic non-touch technique will be utilised for all insertions. Catheters will be BD Insyte ™ Autoguard ™ safety. PIVC size (24G, 22G, 20G etc) will be determined by the inserter, dependent on treatment size and vessel assessment.
Control group
Active

Outcomes
Primary outcome [1] 323038 0
Feasibility of a full-scale efficacy trial will be established by a demonstration that: a) Greater than 60% 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. Feasibility assessed for the first 66 patients only
Timepoint [1] 323038 0
End of trial
Primary outcome [2] 323039 0
Catheter dwell time determined using medical record review, assessed as a primary outcome in the first 66 participants enrolled, after which this outcome was assessed as a secondary outcome.
Timepoint [2] 323039 0
Measured from successful device insertion until removal.
Primary outcome [3] 330853 0
All cause device failure: Cessation of vascular access device function.
composite of (i) infiltration/extravasation (movement of IV fluid into surrounding tissue (infiltration), with or without resulting tissue damage (extravasation); (ii) dislodgement (partial [any post-insertion movement of external catheter length so that the hub is no longer snug to the skin insertion point]) or complete [catheter completely leaves the vein so that infusion is no longer possible]); (iii) phlebitis (two or more signs/symptoms of: pain/tenderness; redness; swelling; or palpable cord/vein streak from the entry site); (iv) device-associated thrombosis (either suspected [increase in limb circumference, distal or proximal to catheter insertion], or confirmed with ultrasound imaging); (v) pain during intravenous infusion (patient reported) ; (vi) local infection (clinical signs of local venous infection at the catheter insertion site (e.g., purulent drainage)) and (vii) primary bloodstream infection (laboratory confirmed bloodstream infection [BSI] as per the Centres for Disease Control, National Health and Safety Network criteria (NHSN). This will be collected daily on purpose built data extraction form and obtained from patient medical records.
Timepoint [3] 330853 0
Collected at device removal and checked at 48 hours post device removal
Secondary outcome [1] 380588 0
Number of insertion attempts (skin puncture to insert device),
Timepoint [1] 380588 0
Number of insertion attempts will be documented by inserter (or observed by the Research Nurse) at the time of insertion of the device
Secondary outcome [2] 380589 0
Insertion failure: Proportion of PIVCs/midlines that are unable to be successfully inserted.
Assessed by the clinical research nurse or inserter and recorded on the clinical report form.
Timepoint [2] 380589 0
Measured from the time of randomisation until 24 hours post-randomisation.
Secondary outcome [3] 380591 0
Primary Bloodstream Infection assessed using hospital records
Timepoint [3] 380591 0
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.
Secondary outcome [4] 380593 0
Number and type of additional vascular access devices required to complete treatment as assessed through direct observation and medical records
Timepoint [4] 380593 0
Treatment completion
Secondary outcome [5] 380594 0
Patient reported pain of insertion
Timepoint [5] 380594 0
Measure immediately following insertion using a developmentally appropriate scale. (Face Legs Activity Cry and Consolability (FLACC) behavioural pain assessment tool in children with cognitive impairment and/or aged 0-5 years, Faces Pain Score (FPS) >5 years -8 years, Numeric rating scale >8years.
Secondary outcome [6] 380595 0
Patient and/or parent reported satisfaction regarding insertion procedure
Timepoint [6] 380595 0
Measured immediately following insertion using a 0-10 verbal rating scale
Secondary outcome [7] 380596 0
Serious adverse events and adverse events (e.g., death, unplanned admission to PICU, extravasation) will be assessed via reviews of hospital records and assessment by the clinical research nurse
Timepoint [7] 380596 0
Until discharge
Secondary outcome [8] 380597 0
Health care costs associated with PIVC and MC including cost of subsequent sequalae. 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 [8] 380597 0
Upon completion of study, on discharge
Secondary outcome [9] 380598 0
Time to insert device assessed via direct observation using a stopwatch
Timepoint [9] 380598 0
From start of procedure, to successful insertion
Secondary outcome [10] 380599 0
Delays to commencement of treatment assessed via direct observation and medical records
Timepoint [10] 380599 0
From randomisation to successful insertion
Secondary outcome [11] 380600 0
Device complication during dwell: composite of (i) infiltration/extravasation (movement of IV fluid into surrounding tissue (infiltration), with or without resulting tissue damage (extravasation); (ii) dislodgement (partial [any post-insertion movement of external catheter length so that the hub is no longer snug to the skin insertion point]) or complete [catheter completely leaves the vein so that infusion is no longer possible]); (iii) phlebitis (two or more signs/symptoms of: pain/tenderness; redness; swelling; or palpable cord/vein streak from the entry site); (iv) device-associated thrombosis (either suspected [increase in limb circumference, distal or proximal to catheter insertion], or confirmed with ultrasound imaging); (v) pain during intravenous infusion (patient reported) ; (vi) local infection (clinical signs of local venous infection at the catheter insertion site (e.g., purulent drainage)) and (vii) primary bloodstream infection (laboratory confirmed bloodstream infection [BSI] as per the Centres for Disease Control, National Health and Safety Network criteria (NHSN).
Timepoint [11] 380600 0
from time of insertion to time of device removal or patient discharge, whatever occurs earlier
Secondary outcome [12] 380601 0
Patient and/or Parent reported satisfaction with the device
Timepoint [12] 380601 0
Measured following device removal 0-10 in hospital using an 11-point visual analog scale - verbal rating scale
Secondary outcome [13] 407828 0
Clinician reported satisfaction with the device
Timepoint [13] 407828 0
Measured immediately following device insertion on a 11 point (0-10) numerical rating sclae of increasing satisfaction.
Secondary outcome [14] 407829 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 [14] 407829 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [15] 407830 0
Dislodgement (partial [any post-insertion movement of external catheter length so that the hub is no longer snug to the skin insertion point]) or complete [catheter completely leaves the vein so that infusion is no longer possible]). As documented in patient medical record or purpose built data extraction form
Timepoint [15] 407830 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [16] 407831 0
phlebitis (two or more signs/symptoms of: pain/tenderness; redness; swelling; or palpable cord/vein streak from the entry site); This will be obtained from patient medical records and collected on purpose built data extraction form..
Timepoint [16] 407831 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [17] 407832 0
local infection (clinical signs of local venous infection at the catheter insertion site (e.g., purulent drainage) confirmed by an infectious disease specialist using de-identified clinical and microbiological data.
Timepoint [17] 407832 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [18] 407833 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 [18] 407833 0
Data collected daily by the clinical research nurse until removal of PIVC
Secondary outcome [19] 407834 0
Device dwell-time (time from insertion to removal, in hours) as recorded on purpose built data extraction form and patient medical records.
Timepoint [19] 407834 0
Collected at device removal
Secondary outcome [20] 407835 0
Healthcare costs, linked to hospital financial records
Timepoint [20] 407835 0
At trial completion

Eligibility
Key inclusion criteria
1. Between 12 months and 18 years of age
2. greater than 2.5mm upper arm vein
3. The treating team have indicated that the patient is expected to require 4 or more days of peripherally compatible intravenous therapy
4. Informed consent to participate
5. Require the insertion of a new intravenous access device
Minimum age
12 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of a co-existent central venous access device
2. Non-English speakers without an interpreter
3. Children under care of department of communities or without a legal guardian
4. Thrombosed vessels in the upper arm distal to the axillar
5. Patient receiving end-of-life care
6. 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)
Centralised web-based randomisation service at Griffith University will be used to generate allocation and maintain allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patient level randomisation will be 1:1 to the Peripheral Intravenous Catheter or Midline Catheter group, with randomly varied blocks of sizes 6 and 8 (1:1 ratio) and stratified by age (12 months-5 years and > 5 years).
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
Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria (e.g. 75% of screened patients eligible, <5% lost to follow up). Descriptive statistics will be used to summarise participant clinical and demographic characteristics, including mean and standard deviation for variables associated with a normal distribution and median and quartile range for non-normally distributed variables. Data will be analysed on an intention to treat basis with device the unit of analysis. An alpha value of p = 0.05 will be considered significant.

Descriptive statistics will be used to summarise participant clinical and demographic characteristics, including mean and standard deviation for continuous variables associated with a normal distribution and median and interquartile range for non-normally distributed variables. Categorical data will be reported as frequency (percentage). Catheter failure rates will be calculated per 1,000 days to account for varied dwell times. An alpha value of p = 0.05 will be considered significant. Data will be analysed on an intention to treat basis with patient the unit of analysis. Qualitative data yielded from interviews will be analysed using inductive thematic analysis using Braun and Clarke framework.

Estimating cost parameters: Healthcare costs will be estimated by assessing the sum product of unit costs, including number of products used and staff time required for device insertion (a sub-set of n=20-30 participants per group, convenience sample). Resource utilisation due to any identified adverse event will be explored based on utilisation data collected by ReN in REDCap. Given potential for small number of events by event category, treatment guidelines, expert opinion and published cost estimates will be used to model expected total cost per adverse event. Resource utilisation, including staff time, will be reported descriptively along with unit prices. The difference in the net mean cost per patient between PIVC and MC will be calculated using linear regression model with intervention group as the main effect. Non linear regression models (for example, general linear model) will be used where the distribution of net cost is skewed. Uncertainty in the economic estimates will be characterised by the 95% confidence interval estimated from the regression model. Predicted net benefit from implementation will be estimated as the expected number of eligible patients that present within a 12 month period multiplied by the estimated difference in mean net costs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2020
Actual
28/07/2020
Date of last participant enrolment
Anticipated
30/01/2023
Actual
7/06/2022
Date of last data collection
Anticipated
1/02/2023
Actual
13/06/2022
Sample size
Target
128
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15990 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 29488 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 305081 0
University
Name [1] 305081 0
Menzies Health Institute Queensland, Griffith University
Country [1] 305081 0
Australia
Funding source category [2] 305572 0
Commercial sector/Industry
Name [2] 305572 0
Becton Dickinson
Country [2] 305572 0
United States of America
Primary sponsor type
Hospital
Name
Queenland Children's Hospital
Address
Queensland Children's Hospital
Children's Health Queensland Hospital and Health Service
501 Stanley Street
South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 305453 0
University
Name [1] 305453 0
Griffith University
Address [1] 305453 0
170 Kessels Rd, Nathan QLD 4111
Country [1] 305453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305472 0
Childrens Health Queensland Human Research Ethics Committee
Ethics committee address [1] 305472 0
Human Research Ethics Committee
Level 7, Centre for Children's Health Research
Queensland Children's Hospital
62 Graham Street
South Brisbane, QLD, 4101
Ethics committee country [1] 305472 0
Australia
Date submitted for ethics approval [1] 305472 0
28/02/2020
Approval date [1] 305472 0
24/04/2020
Ethics approval number [1] 305472 0
HREC/20/QCHQ/53466

Summary
Brief summary
The Queensland Children’s Hospital has identified a need to determine if MCs are superior to PIVCs for patients requiring peripherally compatible intravenous therapy >4 days. Following an internal pilot to determine protocol feasibility we will undertake a randomised controlled trial (RCT) in children requiring administration of peripherally compatible intravenous therapy comparing current PIVC insertion to MC insertion with the primary objective to reduce catheter failure including dislodgement, infection, thrombosis, extravasation/infiltration, phlebitis, and occlusion.
The secondary objectives are:
1. To compare PIVC versus MC in terms of the incidence of individual elements of failure (dislodgement, extravasation, infection, occlusion, pain, phlebitis, and thrombosis).
2. To compare insertion failure of PIVC versus MC.
3. To compare PIVC versus MC in terms of child and parent acceptability and satisfaction of the randomised catheter
4. To compare PIVC versus MC in terms of cost effectiveness in the acute hospital setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100486 0
Ms Tricia Kleidon
Address 100486 0
Queensland Children's Hospital
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100486 0
Australia
Phone 100486 0
+61 7 3068 1135
Fax 100486 0
Email 100486 0
[email protected]
Contact person for public queries
Name 100487 0
Tricia Kleidon
Address 100487 0
Queensland Children's Hospital
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100487 0
Australia
Phone 100487 0
+61 7 3068 1135
Fax 100487 0
Email 100487 0
[email protected]
Contact person for scientific queries
Name 100488 0
Tricia Kleidon
Address 100488 0
Queensland Children's Hospital
Level 4, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham Street
South Brisbane, QLD, 4101
Country 100488 0
Australia
Phone 100488 0
+61 7 3068 1135
Fax 100488 0
Email 100488 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
EmbaseMidline Compared with Peripheral Intravenous Catheters for Therapy of 4 Days or Longer in Pediatric Patients: A Randomized Clinical Trial.2023https://dx.doi.org/10.1001/jamapediatrics.2023.3526
N.B. These documents automatically identified may not have been verified by the study sponsor.