Comparing Inhaled Isoflurane and Intravenous Propofol Sedation in Critically Ill Adults on Mechanical Ventilation

What this Trial Is About

Researchers are comparing two sedation methods for critically ill patients on mechanical ventilation inhaled isoflurane delivered via the Sedaconda ACD-S system versus intravenous propofol. This Phase IV, low-intervention, open-label, randomized controlled trial aims to evaluate which method leads to more ventilator-free days within 28 days post-randomization. The study focuses on patients expected to need deep sedation and mechanical ventilation for over 48 hours in the intensive care unit ICU. Participants will be randomly assigned to one of two groups. One group receives inhaled isoflurane starting at 3 mLh, adjusted to reach a target sedation level without exceeding 14 mLh, guided by end tidal isoflurane concentration. Short periods with higher concentrations may be used. The other group receives intravenous propofol starting at 0.5-1 mgkgh, carefully increased to reach the target sedation without exceeding 4 mgkgh. If sedation targets are not met, a secondary hypnotic may be added in either group. During the study, participants will be monitored for ventilator-free days at 28 days, ICU-free days, time to extubation, sedation effectiveness, use of additional sedatives, and delirium incidence and duration within 28 days. Researchers will also assess mental, cognitive, and quality of life outcomes at 90 days after hospital discharge. Safety, including treatment-related adverse events and mortality up to 60 days, will be tracked. The trial includes 620 patients across multiple centers, with data collected throughout the ICU stay and follow-up periods.

Inhaled Sedation in Critically Ill Patients