Table 1.

Definitions used for Outcome parameters

Outcome parameters	Definition
Effectiveness	The ability of the closed loop mode to institute appropriate settings as reflected by VT, ΔP, MP or FiO2, and to provide lung protective ventilation
Safety	Any adverse event, or discontinuation or change in a ventilator setting related to the closed loop mode under investigation because of unacceptable changes in clinical parameters
Efficacy	The effect of the closed loop mode on patient–related outcomes such as mortality, duration of ventilation, and ICU and hospital lengths of stay
Workload	The effect on staff workload such as the number of manual interventions to ventilator settings, or the number of alarms