Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating inhaled sedation using isoflurane administered via the Sedaconda ACD-S system compared to intravenous sedation with propofol in critically ill patients who require mechanical ventilation. This phase IV, low-intervention, open-label randomized trial aims to determine if isoflurane sedation results in more ventilator-free days at 28 days after randomization. The study also explores effects on ICU stay length, sedation maintenance, delirium incidence, and cognitive and quality of life outcomes up to 90 days post-discharge. Participants will be randomly assigned to one of two groups: one receiving inhaled isoflurane sedation starting at 3 mL/h (up to 14 mL/h) guided by end tidal isoflurane concentration, and the other receiving intravenous propofol starting at 0.5-1 mg/kg/h (up to 4 mg/kg/h). If target sedation levels are not met, additional hypnotic agents may be added. The study includes 620 patients from multiple centers, with sedation maintained until extubation or up to 28 days. During the trial, patients undergo regular assessments of sedation depth, ventilator status, delirium presence, and adverse events until day 28. Cognitive and psychological evaluations occur at 90 days after hospital discharge. Researchers will measure ventilator-free days as the primary outcome and monitor ICU-free days, time to extubation, sedation efficacy, delirium, mortality up to 60 days, and treatment-related adverse events. The total participation may last several months, including follow-up after discharge.

Inhaled Sedation in Critically Ill Patients