Inhaled Sevoflurane for ARDS Prevention (IPA)
Acute Respiratory Distress Syndrome
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Sedation, Inhaled sevoflurane
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than, 4 (Appendix D)105 Patient under invasive mechanical ventilation With expected duration of sedation superior or equal to 4 hours Affiliation to the French Sécurité Sociale Exclusion Criteria: Patient under judicial protection, guardianship or supervision, as defined by art L1121-8 of the Public Health Code Patient under psychiatric care as defined by art. L1121-6 of the Public Health Code Patient deprived of their freedom by judiciary or administrative order Known pregnancy Presence of ARDS prior to randomization Endotracheal ventilation for greater than 24 hours prior to randomization Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (i.e. height inferior to 134cm for a man and 139cm for a woman) Moribund patient, i.e. not expected to survive 24 hours despite intensive care Previous hypersensitivity or anaphylactic reaction to sevoflurane or to the intravenous sedation agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine) Absolute contra-indications to the intravenous sedation agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine) Medical history of malignant hyperthermia Long QT syndrome at risk of arrhythmic events Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane) Suspected or proven intracranial hypertension Enrollment in another interventional trial with direct impact on oxygenation
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Inhaled sedation with sevoflurane
Intravenous sedation
Sevoflurane as vaporized via the Anesthesia Conserving Device (Sedaconda-ACD-S, Sedana Medical, Danderyd, Sweden).
The investigators will not mandate the sedative type, but rather encourage the use of sedatives that are already routinely used in participating ICUs (typically a benzodiazepine, propofol, or dexmedetomidine, i.e. drugs approved for sedation).