Enteral vs Intravenous Italian Trial: a new way for ICU sedation management

Rationale: A relevant innovation about sedation of long-term ICU patients is the "conscious target" even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though it cannot produce deep sedation and it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side-effects and lower costs. Objective: Achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Method/Design: A randomized, controlled, multi-center, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. 300 high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimisation process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, COPD, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed. The participating ICUs have different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. Results/Conclusions: 348 patients have been randomized, through a centralized website, using a software expressly designed for this study. This "educational research" project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically ill patients awake. (clinicaltrials.gov #NCT01360346)