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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
7/07/2020
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.
Timepoint [1] 323038 0
End of trial
Primary outcome [2] 323039 0
Catheter dwell time, assessed using medical record data
Timepoint [2] 323039 0
Measured from successful device insertion until 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] 380590 0
All-cause post-insertion failure: A composite of 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 bloodstream infection).

Pain assessed using visual analog scale (0-10)
Infiltration and extravasation, movemnt of fluids into the surrounding tissues will be assessed using visual assessment
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.
Venous thrombosis: Confirmed Ultrasound/venographic confirmed thrombosed vessel at the site in a symptomatic patient, or a symptomatic patient with a thrombus/fibrin sheath occluding 1 or more lumens at device removal.
Dislodgement: Partial - Change in device length at insertion site (inner catheter visible), displacement of the device tip so it is no longer optimally positioned, however remains in the vein, Total - device completely leaves the vein.
Local site infection: Laboratory confirmed local infections, involving skin swabs and M/C/S.
Phlebitis: Defined as 2 or more of pain, redness, swelling.
Occlusion: Unable to inject or aspirate from the device

Timepoint [3] 380590 0
This composite measure incorporates the multifocal path to the same endpoint; device failure.
Assessed by linkage to daily medical records and during daily data collection by the clinical research nurse.
Secondary outcome [4] 380591 0
Primary Bloodstream Infection assessed using hospital records
Timepoint [4] 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 [5] 380593 0
Number and type of additional vascular access devices required to complete treatment as assessed through direct observation and medical records
Timepoint [5] 380593 0
Treatment completion
Secondary outcome [6] 380594 0
Patient reported pain of insertion
Timepoint [6] 380594 0
Measure immediately following insertion using a developmentally appropriate 0-10 rating scale
Secondary outcome [7] 380595 0
Patient and/or parent reported satisfaction regarding insertion procedure
Timepoint [7] 380595 0
Measured immediately following insertion using a 0-10 verbal rating scale
Secondary outcome [8] 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 [8] 380596 0
Until discharge
Secondary outcome [9] 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 [9] 380597 0
Upon completion of study, on discharge
Secondary outcome [10] 380598 0
Time to insert device assessed via direct observation using a stopwatch
Timepoint [10] 380598 0
From start of procedure, to successful insertion
Secondary outcome [11] 380599 0
Delays to commencement of treatment assessed via direct observation and medical records
Timepoint [11] 380599 0
From randomisation to successful insertion
Secondary outcome [12] 380600 0
Complication during treatment not requiring removal assessed via review of hospital records
Timepoint [12] 380600 0
until discharge
Secondary outcome [13] 380601 0
Patient and/or Parent reported satisfaction with the device
Timepoint [13] 380601 0
Measured following device removal 0-10 in hospital using an 11-point visual analog scale - verbal rating scale

Eligibility
Key inclusion criteria
1. Between 3 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
3 Years
Maximum age
18 Years
Gender
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 (3-5 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.


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<0.05 significant). Qualitative data yielded from interviews will be analysed using inductive thematic analysis using Braun and Clarke framework.

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] 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
Address [1] 305081 0
170 Kessels Rd, Nathan QLD 4111
Country [1] 305081 0
Australia
Funding source category [2] 305572 0
Commercial sector/Industry
Name [2] 305572 0
Becton Dickinson
Address [2] 305572 0
1 Becton Drive
Franklin Lakes, NJ 07417
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
Peripheral intravenous catheter (PVC) insertion is the most frequent invasive procedure in hospitals, but are susceptible to complications, with failure rates as high as 69%. Midline catheters (MCs) are an alternative device for patients requiring >72 hours of intravenous therapy. A recent observational data reported MC successful functional dwell of 7.7-16.4 days, comparing starkly with the average PVC dwell of 2.4-4.2 days. Therefore, MC use could potentially result in patients needing only one device per treatment, in comparison to multiple PVCs. Currently it is unclear whether PVCs or MCs are superior in paediatric patients. This pilot randomised control trial will test the feasibility of a large study comparing PVCs and MCs. A total of n=66 participants between the ages of 3 and 18 years will be recruited. Primary outcomes are (1) feasibility and (2) dwell time. Results of this study will inform healthcare practice, provide reliable estimates of the comparative effect of these devices, and inform the feasibility of conducting a larger, definitive trial.

The primary objective of this study is to determine the feasibility of conducting a definitive randomised controlled trial which compares the efficacy of MC versus PIVC in paediatric patients requiring prolonged (>4 days) peripherally compatible therapy as well as compare the dwell time of midline catheters (MC) versus peripheral intravenous catheter (PIVC) in children <18 years.

The secondary objectives are:
1. To compare insertion failure of both MC and PIVC.
2. Compare rates of device complication and failure prior to completion of treatment of both MC and PIVC.
3. Gather child and parent perspectives of MC and PIVC acceptability and satisfaction
4. Identify, measure and compare the healthcare costs between patients who receive a PIVC or MC
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
tricia.kleidon@health.qld.gov.au
Contact person for public queries
Name 100487 0
Ms 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
tricia.kleidon@health.qld.gov.au
Contact person for scientific queries
Name 100488 0
Ms 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
tricia.kleidon@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