Respiratory failure & ventilation

Inhaled Sedation in Acute Respiratory Distress Syndrome: The SESAR Randomized Clinical Trial

JAMAPublished Randomised controlled trial

Authors' conclusion

Among patients with moderate to severe ARDS, inhaled sedation with sevoflurane resulted in fewer ventilator-free days at day 28 and lower 90-day survival than sedation with propofol.

Study context

Population
Adults with early moderate to severe ARDS (PaO2/FiO2 <150 mm Hg with PEEP ≥8 cm H2O), 37 French ICUs
Participants
687 adults
Comparison
Inhaled sevoflurane vs IV propofol sedation for up to 7 days
  • Sevofluranen = 346
  • Propofoln = 341reference
Primary endpoint
Number of ventilator-free days
Follow-up
28 days
Methodological detailsphase 3, open-label, assessor-blinded, multicentre, May 2020 to October 2023, 90-day follow-up, 37 French ICUs
  • Phase 3
  • Open-label
  • Assessor-blinded
  • Multicentre
  • May 2020 to October 2023, 90-day follow-up
  • 37 French ICUs

Primary result

As reported in the abstract

Ventilator-free days through day 28 · day 28

Sevoflurane

0.0

IQR 0.0–11.9 · days

Propofol

0.0

IQR 0.0–18.7 · days

Each group vs propofolMedian difference (95% CI)
Sevoflurane
−2.1(−3.6 to −0.7)
Each group vs propofolStandardized hazard ratio (95% CI)
Sevoflurane
0.76(0.50–0.97)

Secondary outcomes

OutcomeSevofluranePropofolEstimate
90-day survival (key secondary end point)47.1%55.7%HR for death 1.31 (95% CI 1.05–1.62)
7-day mortality · up to 7 days19.4%13.5%RR 1.44 (95% CI 1.02–2.03)
OutcomeMedian difference (95% CI)
ICU-free days through day 28−2.5 (−3.7 to −1.4)

Original publication

Inhaled Sedation in Acute Respiratory Distress Syndrome: The SESAR Randomized Clinical Trial. JAMA. Published 13 May 2025. doi:10.1001/jama.2025.3169

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