Table 1 Primary and secondary study outcomes
From: Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial
Primary outcome | Secondary outcomes |
|---|---|
Percentage of efficacy (measured as observed RASS = target RASS ±1) | - Sedation protocol effectiveness (percentage of ‘protocol violation days’ on the total of ICU days) |
|  | - Delirium- and coma-free days (respectively negative CAM-ICU and RASS ≥ −3 in all daily observations until ICU day 28) |
| Â | - Ventilation-free days |
| Â | - Nursing evaluation of sedation adequacy (communication skills, cooperation, environment tolerance) |
| Â | - Overall ICU and hospital mortality |
| Â | - Absolute mortality 1 year after ICU discharge |
| Â | - Sedative drug costs |
|  | - Indirect markers of inefficacy and side effects, like prevalence of ‘dangerous episodes’ (self-extubation, removal of other invasive tools), length of ICU and hospital stay, use of anti-psychotic drugs as indirect marker of delirium, indicators of sedation failure (use of physical restraints, antagonists administration like flumazenil or naloxone), sepsis prevalence. |