Evaluation of a closed loop sampling system in intensive care: A pilot randomised controlled trial (ENCLOSE)

Blood sampling to inform decision making is an important aspect of intensive care. This is often facilitated by vascular access devices (VADs) connected to fluid administration and monitoring systems. Repeated blood sampling either via phlebotomy or VADs can result in blood wastage and contamination, which can lead to iatrogenic anaemia and systemic infection. This study supported by the Royal Brisbane and Women's Hospital (RBWH) Foundation Research Grant is a single site, two arm, parallel group, pilot randomised controlled trial comparing two different practices for blood sampling in critically ill patients.

In this pilot study 80 eligible patients (40 per group) will be enrolled and allocated into one of two groups; 1) Control group - Open system sampling (OS) and 2) Experimental group - Closed system sampling (CS).

The primary aim of the study is to test the feasibility of trial protocol, recruitment and data collection processes and establish effect size to inform a follow on a large, multi-site, randomised controlled trial. Secondary study objectives are to evaluate the impact of a closed-loop blood sampling system and bundled strategies on blood sample volumes and infection outcomes. The results of this study will inform follow trial work and grant applications to support this.