Actively Recruiting
Inhaled Sevoflurane for ARDS Prevention
Led by University Hospital, Clermont-Ferrand · Updated on 2024-07-29
80
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inhaled Sevoflurane for ARDS Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admitted to a participating ICU with at least one known risk factor for ARDS and a Lung Injury Prediction Score (LIPS) of 4 or higher
- Currently receiving invasive mechanical ventilation
- Expected sedation duration of 4 hours or more
- Affiliated with the French S�e9curit�e9 Sociale system
You will not qualify if you...
- Under judicial protection, guardianship, or supervision as defined by French Public Health Code
- Under psychiatric care as defined by French Public Health Code
- Deprived of freedom by judicial or administrative order
- Known pregnancy
- Diagnosed with ARDS before randomization
- Receiving endotracheal ventilation for more than 24 hours before randomization
- Using home mechanical ventilation except CPAP/BIPAP for sleep-disordered breathing
- Height less than 134 cm for men or 139 cm for women resulting in tidal volume below 200 mL/kg predicted body weight
- Moribund and not expected to survive 24 hours despite intensive care
- Previous hypersensitivity or anaphylaxis to sevoflurane or routine intravenous sedation agents
- Absolute contraindications to routine intravenous sedation agents
- History of malignant hyperthermia
- Long QT syndrome with risk of arrhythmia
- History of liver disease linked to halogenated agents
- Suspected or proven intracranial hypertension
- Participation in another interventional trial affecting oxygenation
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Clermont-Ferrand
Clermont-Ferrand, Not Required For This Country, France, 63000
Actively Recruiting
Research Team
L
Lise Laclautre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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