SEvoflurane for Sedation in ARds (NCT04235608) | Clinical Trial Compass
CompletedPhase 3
SEvoflurane for Sedation in ARds
France700 participantsStarted 2020-05-03
Plain-language summary
This study evaluates whether a sedation with inhaled sevoflurane will decrease mortality and increase time off the ventilator at 28 days in patients with acute respiratory distress syndrome (ARDS).
Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation with propofol.
Who can participate
Age range18 Years
SexALL
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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
* Previou…