A Phase 4 interventional study of sevoflurane and midazolam in Acute Respiratory Distress Syndrome, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University Hospital, Clermont-Ferrand · Phase 4, Interventional, and Treatment
Numerous trials support the efficacy and safety of volatile anesthetic agents, namely inhalation of sevoflurane through dedicated devices, for the sedation of ICU patients. Several preclinical studies have shown that sevoflurane inhalation improves gas exchange and decreases pulmonary and systemic inflammation in experimental models of acute respiratory distress syndrome (ARDS).
The purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of an early 48-hour sevoflurane inhalation on gas exchange and inflammation in patients with ARDS.
BACKGROUND:
Acute respiratory distress syndrome (ARDS) is characterized by hypoxemic respiratory failure that can be lethal in 30 to 60% of patients. Its pathophysiological landmark, diffuse alveolar damage, is associated with alveolar inflammation, epithelial injury and alveolar fluid clairance impairment.
Several preclinical studies have shown that early sevoflurane inhalation improves gas exchange, reduces alveolar edema and attenuates pulmonary and systemic inflammation in experimental models of ARDS.
To date, no clinical trial has assessed the effects of early sevoflurane inhalation in ARDS patients.
DESIGN NARRATIVE:
The purpose of this prospective, randomized, controlled study is to evaluate the effects of a 48-hour sevoflurane inhalation strategy on gas exchange and both systemic and pulmonary inflammation in the early phase of ARDS.
After inclusion, ICU patients with moderate to severe ARDS (according to the Berlin definition of ARDS criteria; JAMA 2010) will be randomized into two groups :
Bronchoalveolar lavages (BAL) and blood samples will be assessed before randomization and at 48 hours, in order to measure tumor necrosis factor-alpha (TNFα), interleukin (IL)-1β, IL-6, IL-8 and sRAGE levels. Duplicate assays will be performed with Multiplex (TNFα/interleukins) or ELISA (sRAGE).
During the 48-hour treatment period, bispectral index (BIS®) values ranging from 40 to 50 will be targeted and neuromuscular blocking agents (cisatracurium) will be administered in both groups. Protective ventilation strategies will be applied, as well as other guidelines or recommendations on the management of ICU patients with ARDS.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
a "conventional group", in which intravenous sedation with midazolam will be administered
Drug: midazolam
a "sevoflurane group", in which patients will inhale sevoflurane during a 48 hour-period, through dedicated devices
Drug: sevoflurane
Sedation with inhaled sevoflurane
Sedation with intravenous midazolam
PaO2/FiO2 ratio
Time frame: at 48 hours
- Plasma and alveolar levels of proinflammatory cytokines : tumor necrosis factor alpha (TNFα, interleukin (IL)-1β, IL-6, IL-8
Time frame: at 48 hours
Plasma and alveolar levels of sRAGE
Time frame: at 48 hours
PaO2/FiO2 ratio
Time frame: at day 1, day 3, day 5
Lowest PaO2/FiO2 during the first 5 days of the study
Time frame: at 5 days
Mean PaO2/FiO2 ratio during the first 5 days of the study
Time frame: at 5 days
Pulmonary static compliance, resistance and elastance
Time frame: at day 1, day 2
Duration of controlled mechanical ventilation
Time frame: at day 30
Total duration of mechanical ventilation (controlled/assisted)
Time frame: at day 30
Number of ventilatory-free days
Time frame: at day 30
Number of organ failure-free days
Time frame: at day 30
Vasopressor requirements
Time frame: at 48 hours
Mortality
Time frame: at day 30
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University Hospital, Clermont-Ferrand