Statistical analysis plan for a randomised controlled trial: Clinical effectiveness of peripheral intravenous device selection and insertion by a vascular access specialist (The SELECT Trial)

The "Clinical effectiveness of peripheral intravenous device selection and insertion by a vascular access specialist" (The SELECT Study)" is a single-centre two-arm superiority randomised clinical trial (RCT). This RCT aims to compare peripherally placed IV device selection and insertion by a Vascular access specialist with a generalist inserter. The purpose for this document is to minimise bias and ensure transparency and internal validity for the findings of the trial, by defining and making publicly available the analysis approach prior to reviewing or analysing trial data. The statistical analysis plan will inform analysis and reporting of the main effectiveness findings of the trial. It provides a detailed description of the primary and secondary trial outcomes and the methods for statistical comparison.