Managing intravenous devices among patients with limited vascular access or prolonged therapy: investigating the efficacy of Midline catheters – the MIDLINE study

The Midline Study: a pilot randomised controlled trial to compare the efficacy of Peripheral Venous Catheters with Midline catheters for adult hospitalised patients with limited vascular access or prolonged therapy.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000383167

Acronym

The MIDLINE Study

Enrollment

140

Registered

2019-03-12

Start date

2019-05-20

Completion date

2020-03-12

Last updated

2020-04-27

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

Conditions

None listed

Brief summary

Peripheral Venous Catheters (PVC) are inserted for the administration of medications and fluid;. two billion are sold worldwide annually. While patient need for PVCs is high, up to 69% fail due to complications such as occlusion or phlebitis necessitating additional PVC insertions to complete treatment. PVC replacements increase healthcare costs (staff time/equipment) and some patients require higher risk central venous device, because they have run out of PVC insertion sites. Midline catheters (MCs) are an alternative to PVCs, increasingly used, but rarely in Queensland, Australia. On average 10cms long, they terminate at the axillary vein, not in the central venous circulation. As with any invasive device, leaking, infection and thrombosis can occur. Their rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PVCs. There have been no randomised controlled trials (RCTs) comparing these devices to guide practice. This pilot randomised control trial will test the feasibility of a large study comparing PVCs and MCs for patients with difficult vascular access and/or prolonged therapy.

Interventions

Adult medical and surgical in-patients in this study require intravenous therapy for treatment; consenting patients will receive either a Peripheral Venous Catheter (control) or a Midline Catheter (intervention) for the delivery of this treatment. This device will be inserted by either the Research Nurse or the treating clinician (dependent upon competency and availability). Intervention: Midline Catheter (MC). MC are approximately 8-20cms in length and are inserted into the upper arm, terminating at the axillary vein. The randomly allocated device will remain in place until removal as a result of failure, completion of therapy, or routine replacement (if applicable). There will be daily checks of the insertion site to monitor protocol adherence and assess for any complications.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• equal to or more than 18 years of age; • The treating team have indicated that the patient is expected to require equal to or more than 5 days peripherally compatible intravenous therapy; or • difficult access patient (equal to or less than 2 visible and palpable veins); • Informed consent to participate.

Exclusion criteria

• Current positive bloodstream infection (within 24 hours), with the exclusion of a single common skin contaminant (as defined by NHSN) • Presence of a co-existent central venous access device • Non-English speakers without interpreter • Patient receiving end-of-life care • Cognitive barrier to consent (without a substitute decision maker) • Previous enrolment in this study

Outcome results