SEvoflurane for Sedation in ARds (SESAR)

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS, Sedation, Inhaled sevoflurane Read More

Inclusion Criteria:

• Age ≥18 years

• Presence for ≤24 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms:

  • PaO2/FiO2 <150 mmHg with positive end-expiratory pressure (PEEP) ≥8 cmH2O (or, if arterial blood gas not available, SpO2/FiO2 that is equivalent to a PaO2/FiO2 <150 mmHg with PEEP ≥8 cmH2O and a confirmatory SpO2/FiO2 between 1-6 hours after the initial SpO2/FiO2 determination)
  • Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules
  • Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present

Exclusion Criteria:

• Absence of affiliation to the French Sociale security
• Patient under a tutelage measure or placed under judicial protection
• Continuous sedation with inhaled sevoflurane at enrollment
• Known pregnancy
• Currently receiving ECMO therapy
• Chronic respiratory failure defined as PaCO2 >60 mmHg in the outpatient setting
• Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing
• Body mass index >40 kg/m2
• Chronic liver disease defined as a Child-Pugh score of 12-15
• Expected duration of mechanical ventilation <48 hours
• Moribund patient, i.e. not expected to survive 24 hours despite intensive care
• Burns >70% total body surface
• Previous hypersensitivity or anaphylactic reaction to sevoflurane or cisatracurium
• 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)
• Known hypersensitivity to propofol or any of its components
• Known allergy to eggs, egg products, soybeans, and soy products
• Suspected or proven intracranial hypertension
• Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (as recommended by the manufacturer for the use of the AnaConDa-S (Sedana Medical, Danderyd, Sweden)
• Enrollment in another interventional ARDS trial with direct impact on sedation and mechanical ventilation
• Endotracheal ventilation for greater than 120 hours (5 days)
• Persistent bronchopleural fistula despite chest tube drainage
• PaO2/FiO2 (if available) >200 mmHg after meeting inclusion criteria and before randomization