A randomized single-blinded simulation-based trial of a novel method for fluid administration to a septic infant

Abstract

Objectives For children presenting in shock, American College of Critical Care Medicine guidelines recommend 3 boluses of intravenous fluids during initial resuscitation, but these are often not met. This study aims to compare a novel device LifeFlow, to established manual methods for rapid fluid delivery in a simulated environment. Method This single-blinded randomized trial was conducted in a level 1 pediatric trauma center emergency department. Fifty-four participants were paired and randomized to one of the following methods: push/pull, pressure bag, or LifeFlow. The teams were presented with a standardized simulation-based case and asked to resuscitate a 10-kg patient in decompensated shock. We used a demographic survey to study provider variables, recordings of the simulation and fluid delivery to independently establish rate and accuracy, and the National Aeronautical and Space Administration Task Load Index to assess workload. Result All 54 participants completed the assigned tasks, and no significant differences were found among the demographics of participants. The primary outcome (mean rate of fluid administration) differed significantly between the 3 techniques, LifeFlow being the fastest (65.29 mL/min). The composite National Aeronautical and Space Administration Task Load Index score (30; P = 0.184) was lowest for the LifeFlow. Significant differences were seen among the correlation coefficient comparing the estimated to the actual volume of fluid for each method, pressure bag being the highest (0.66), followed by push-pull (0.54) and LifeFlow (0.31). Conclusions LifeFlow allowed for faster fluid administration rate and thus could be the preferred technique for rapid fluid resuscitation in pediatrics patients. Further investigations should explore the reproducibility of these results using this device in real patients in multiple centers.