ANZCTR - Registration

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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]

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

Condition category

Condition code

Anaesthesiology

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]

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]

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]

End of trial

Primary outcome [2]

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]

Measured from successful device insertion until removal.

Primary outcome [3]

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]

Collected at device removal and checked at 48 hours post device removal

Secondary outcome [1]

Number of insertion attempts (skin puncture to insert device),

Timepoint [1]

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]

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]

Measured from the time of randomisation until 24 hours post-randomisation.

Secondary outcome [3]

Primary Bloodstream Infection assessed using hospital records

Timepoint [3]

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]

Number and type of additional vascular access devices required to complete treatment as assessed through direct observation and medical records

Timepoint [4]

Treatment completion

Secondary outcome [5]

Patient reported pain of insertion

Timepoint [5]

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]

Patient and/or parent reported satisfaction regarding insertion procedure

Timepoint [6]

Measured immediately following insertion using a 0-10 verbal rating scale

Secondary outcome [7]

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]

Until discharge

Secondary outcome [8]

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]

Upon completion of study, on discharge

Secondary outcome [9]

Time to insert device assessed via direct observation using a stopwatch

Timepoint [9]

From start of procedure, to successful insertion

Secondary outcome [10]

Delays to commencement of treatment assessed via direct observation and medical records

Timepoint [10]

From randomisation to successful insertion

Secondary outcome [11]

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]

from time of insertion to time of device removal or patient discharge, whatever occurs earlier

Secondary outcome [12]

Patient and/or Parent reported satisfaction with the device

Timepoint [12]

Measured following device removal 0-10 in hospital using an 11-point visual analog scale - verbal rating scale

Secondary outcome [13]

Clinician reported satisfaction with the device

Timepoint [13]

Measured immediately following device insertion on a 11 point (0-10) numerical rating sclae of increasing satisfaction.

Secondary outcome [14]

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]