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SEvoflurane for Sedation in ARds — SESAR  

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE: To assess the efficacy of a sedation with inhaled sevoflurane in improving in reducing mortality and morbidity in patients with moderate-severe ARDS in comparison to a control group receiving intravenous sedation with propofol. PRIMARY HYPOTHESIS: Inhaled sedation with sevoflurane will improve a composite outcome of mortality and time off the ventilator at 28 days, in patients with moderate-severe ARDS. The trial will accrue a maximum of 700 patients. Patients will be recruited from participating intensive care units and randomized to the active (inhaled sevoflurane) or control (intravenous propofol). The overall strategy is to screen and enroll early, every newly intubated, acutely ill or postoperative, patient at each site, using clinically obtained pulse oximetry and blood gases. By providing superior awakening and extubation times, as well as lung-protective effects from anti-inflammatory and protective effects from epithelial injury, inhaled sevoflurane may hasten recovery from lung injury and improve outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04235608
Study type Interventional
Source University Hospital, Clermont-Ferrand
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 3, 2020
Completion date October 2, 2024
View Details
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