IIT, Investigator Initiated Trials

In addition to its own clinical studies, Sedana Medical supports independent research in the field of inhaled sedation. 

SESAR 

The SESAR study (led by Associate Professor Matthieu Jabaudon at Centre Hospitalier Universitaire Clermont-Ferrand) is a randomised, controlled study involving 700 intensive care patients with acute respiratory distress syndrome (ARDS). Treatment with inhaled sedation with sevoflurane for up to seven days is compared to intravenous propofol. The primary objective is to assess the efficacy of inhaled sedation measured as ventilator-free days at day 28, considering death as a competing event. The study involves 30 ICUs across France and is expected to be completed by 2023. 

 

INASED 

The INASED study (led by Dr Pierre Bailly and Professor Erwan L’Her at Centre Hospitalier Regionale Universitaire Brest) is a randomised, controlled study involving 250 patients who are anticipated to need mechanical ventilation in an ICU for more than 24 hours. The primary objective is to assess the incidence of delirium following inhaled sedation compared to intravenous propofol. The study is being carried out at 10 ICUs in France and its completion is planned for 2023. 

 

ISCA 

The ISCA study (led by Associate professor Matthieu Jabaudon, France, Associate professor Martin Schläpfer, Switzerland, Professor Rafael Badenes, Spain and Associate professor Tobias Becher, Germany) is an observational, retrospective study of 400 COVID-19-related ARDS patients comparing the outcome of those treated with inhaled sedation (isoflurane or sevoflurane) versus intravenous sedation. The primary objective is to assess the efficacy of inhaled sedation measured as ventilator-free days at day 28, considering death as a competing event. The study involves 30 ICUs across France, Germany, Spain, and Switzerland, and is planned to finalise in 2021.