Trial name or title

Reliable Intravenous Access by Line Experts (RELIABLE): a pilot randomised controlled trial to compare peripheral venous catheter insertion by vascular access specialists with any clinician (generalist model, standard practice) on clinical and economic outcomes among

medical and surgical patients

Methods

Randomized controlled trial

Participants

Patients from the medical and surgical departments who require a PVC for longer than 24 hours will be eligible for inclusion in this study. Consenting patients will have their PVC inserted by a vascular access specialist (intervention) or a generalist clinician (control).

Interventions

Arm 1 (control): PVC inserted as per hospital policy by a credentialed PVC inserter (generalist approach).

Arm 2 (intervention): vascular access specialist, defined as a registered nurse with advanced knowledge of vascular access including catheter technology, dressings, modalities of catheter access, and intravenous therapy management.

A substudy will consider use of ultrasound for assessment of veins, but not for the insertion procedure.

Outcomes

The primary outcome is to establish the feasibility of conducting an adequately powered randomized controlled trial in the future. Feasibility measures will include: patient eligibility (more than 90% of those screened); consent (more than 90% agree to enrol); protocol adherence (more than 90% receive the allocated intervention); and retention (less than 5% of enrolled participants lost to follow‐up). Secondary outcomes include: phlebitis: defined as 2 or more of pain, redness, swelling, palpable cord, or purulent discharge. Infiltration and extravasation: defined as the movement of IV fluids into the surrounding tissue with/without resulting tissue breakdown. Occlusion: defined as the PVC will not infuse, or leakage occurs when fluid is infused.

Dislodgement (either partial or total): partial: change in PVC length at insertion site (inner catheter visible); total: PVC completely leaves the vein. Infection (laboratory‐confirmed local or bloodstream infection): PVC skin swabs, PVC tip and blood cultures may be collected as per usual clinical practice if clinical suspicion of local infection or systemic infection. PVC dwell time: from the time of PVC insertion until removal from either device failure, routine replacement, or the completion of IV therapy. Cost‐effectiveness: estimates of costs of staff resources, equipment, and PVC failure resource usage with previously developed cost estimations. Detailed resources used for a PVC insertion and removal will be recorded for a subset of 15 participants per study group. Staff and patient acceptability of the intervention assessed on a 0‐to‐10 Likert scale

Starting date

Not yet recruiting

Contact information

Ms Nicole Marsh

Nursing and Midwifery Research Centre

Level 2, Building 34

Royal Brisbane and Women's Hospital

Cnr Bowen Bridge Road & Butterfield Street

Herston, QLD, 4029

Notes