The MIDLINE trial – managing intravenous devices among patients with limited vascular access or prolonged therapy: a pilot randomised control trial protocol

Marsh, Nicole and Larsen, Emily and Flynn, Julie ORCID: and O’Brien, Catherine and Kleidon, Tricia and Groom, Peter and Hewer, Barbara and Rickard, Claire M. (2020) The MIDLINE trial – managing intravenous devices among patients with limited vascular access or prolonged therapy: a pilot randomised control trial protocol. Vascular Access, 6 (1). pp. 20-24.


Introduction Peripheral intravenous catheters (PIVCs) are essential for administration of intravenous fluids and medications. While patient need for PIVCs is high, up to 69% fail due to complications such as occlusion and infiltration. Midline catheters (MCs) are an alternative to PIVCs; they are 8–20cms in length and terminate at, or are distal to, the axillary vein, not in the central venous circulation. Midline catheters’ rising popularity is due to concerns that patients’ veins are depleted by multiple consecutive PIVCs. However, there have been no randomised controlled trials (RCTs) comparing these devices to guide practice. Methods and analysis This single centre, parallel group, pilot RCT is designed to compare effectiveness of MCs with PIVCs for patients with difficult vascular access (≤2 visible and palpable veins) and/or receiving peripherally compatible intravenous therapy for ≥5 days. This trial will be conducted at the Royal Brisbane and Women’s Hospital, Australia. The recruitment target is 70 participants per group (n=140). There are three primary outcomes of interest to test: 1) Feasibility of an adequately powered RCT with pre-established criteria for eligibility, recruitment, protocol adherence and retention; 2) Insertion failure (number of PIVCs/MCs unable to be inserted); and
3) Post-insertion failure: all-cause failure. Secondary outcomes to be collected include: number of insertion attempts; time to insert; catheter dwell time; costs (staff time/equipment); patient-reported insertion pain; and individual causes of failure, e.g. phlebitis. Feasibility outcomes will be reported descriptively and analysed against pre-determined acceptability criteria. As a pilot study, statistical comparison methods will be tested. Cox regression will assess the effect of patient and treatment differences.

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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Faculty/School / Institute/Centre: No Faculty
Faculty/School / Institute/Centre: No Faculty
Date Deposited: 14 Dec 2021 04:33
Last Modified: 15 Dec 2021 03:32
Uncontrolled Keywords: intravenous; vascular access devices; midline catheter; peripheral intravenous catheter; randomised controlled trial; phlebitis
Fields of Research (2008): 11 Medical and Health Sciences > 1110 Nursing > 111003 Clinical Nursing: Secondary (Acute Care)
11 Medical and Health Sciences > 1110 Nursing > 111099 Nursing not elsewhere classified
Fields of Research (2020): 42 HEALTH SCIENCES > 4205 Nursing > 420506 Sub-acute care
42 HEALTH SCIENCES > 4205 Nursing > 420501 Acute care
42 HEALTH SCIENCES > 4205 Nursing > 420599 Nursing not elsewhere classified
Identification Number or DOI: doi:10.33235/va.6.1.20-24

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