The study aims to demonstrate that inhaled sedation with isoflurane delivered by the Sedaconda ACD device is safe, cost-effective, and with a lower incidence of delirium, in comparison to the commonly used intravenous sedative agents propofol and midazolam.
The study will be carried out in the General Intensive Care Unit at the Hadassah University Hospital, Jerusalem, and will involve 1000 mechanically ventilated patients in the ICU who will be compared to historical matched controls (3 controls per patient, 3000 in total). During the two years that the study is planned for, inhaled sedation with isoflurane will be introduced as the standard of care for all stable ventilated patients in ICU.
The main outcome measures are duration of mechanical ventilation, ICU length of stay, and cost of all sedative medications administered. Secondary endpoints include mortality, incidence of delirium, vasopressor/inotrope doses, and incidence of renal failure.