Standard versUs peRForated (SURF) peripheral intravenous catheter trial: a pilot randomised controlled trial protocol

Abstract

Introduction: Contrast-enhanced computed tomography (CECT) scanning requires a large bore peripheral intravenous catheter (PIVC) to support the high-flow injection of contrast needed to generate a quality image. Unfortunately, not all patients’ veins will tolerate high-flow injection and this can subsequently lead to complications, procedural delays, use of alternate intravascular access, and potential compromise of scan image. This study will evaluate the effectiveness of perforated catheters compared to standard catheters in reducing PIVC complications and failure during high-flow injection for CECT scans. Methods and analysis: This single-centre, parallel-group, pilot randomised controlled trial (RCT) will be undertaken to test the feasibility of conducting a larger trial comparing a PIVC with a novel perforated design to a standard (non-perforated) PIVC. The study will be conducted at the Royal Brisbane and Women’s Hospital, Australia, and the recruitment target is 60 (30 per group). There are two primary outcomes of interest to test: 1) Feasibility of an adequately powered RCT with pre-established criteria for eligibility, recruitment, protocol adherence and retention; and 2) All cause PIVC failure rate. Secondary outcomes to be collected include first insertion success, subtypes of PIVC failure, PIVC dwell time, contrast delivery, and CECT image quality. Adverse and serious adverse events (i.e., extravasation, allergic reaction to the contrast) also will be monitored. Feasibility outcomes will be reported descriptively and assessed against pre-determined acceptability criteria. Statistical comparison methods will be tested. Regression analysis will assess the effect of patient and treatment differences. Ethics and trial commencement: This pilot trial has ethical approval from Queensland Health (HREC/2019/QRBW/55616) and Queensland University of Technology (QUTHREC/1900001090).