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Prolonged administration of Intravenous Medication through Midline compared to Standard peripheral intravenous cannula in children

Prolonged administration of Intravenous Medication through Midline compared to Standard peripheral intravenous cannula in children to reduce catheter failure.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000724976
Acronym
PIMMS
Enrollment
128
Registered
2020-07-07
Start date
2020-07-28
Completion date
2022-06-07
Last updated
2022-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 loc

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.

Sponsors

Queenland Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Months to 18 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026