← Back to Clinical Trials
Recruiting Phase 3 NCT05849779

Inhaled Sevoflurane for ARDS Prevention

Trial Parameters

Condition Acute Respiratory Distress Syndrome
Sponsor University Hospital, Clermont-Ferrand
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-24
Completion 2026-05-31
Interventions
Inhaled sedation with sevofluraneIntravenous sedation (current practice)

Brief Summary

This study focuses on patients who are at risk of developing a serious, life-threatening respiratory disease called Acute Respiratory Distress Syndrome (ARDS), which severely disrupts the function of their lungs. Preclinical studies have shown that the use of a volatile anesthetic agent such as Sevoflurane could be beneficial in the treatment and prevention of this respiratory condition. By improving gas exchange and attenuating pulmonary inflammation in particular, this agent would make it possible to prevent deterioration or to restore pulmonary function more rapidly. Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation already routinely used in participating ICUs (typically propofol, dexmedetomidine or a benzodiazepine, i.e. drugs approved for sedation). The aim of this study is to assess whether the use of Sevoflurane could be beneficial in the prevention of ARDS.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. 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 3. Patient under invasive mechanical ventilation 4. With expected duration of sedation superior or equal to 4 hours 5. 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 t

Related Trials