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Randomized Clinical Trial of Inhaled Sedation with Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome
EU CTIS ID: 2024-517670-15-00
What this study is testing
To assess the efficacy of inhaled sevoflurane, compared to current intravenous sedation practice, for improving PaO2/FiO2 in ICU patients at high risk for ARDS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than 4
- Patient under invasive mechanical ventilation
- With expected duration of sedation superior or equal to 4 hours
- Affiliation to the French Sécurité Sociale
You likely can't join if
- Patient under a tutelage measure
- 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 to 134cm for a man and 139cm for a woman)
- Moribund patient, i.e. not expected to survive 24 hours despite intensive care
See the full eligibility criteria
- Age ≥ 18 years
- Admitted to participating ICUs with at least one known risk factor for ARDS and a LIPS equals to, or greater than 4
- Patient under invasive mechanical ventilation
- With expected duration of sedation superior or equal to 4 hours
- Affiliation to the French Sécurité Sociale
- Patient under a tutelage measure
- 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 to 134cm for a man and 139cm for a woman)
- Moribund patient, i.e. not expected to survive 24 hours despite intensive care
- Previous hypersensitivity or anaphylactic reaction to sevoflurane or to the intravenous sedation agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine)
- Contra-indications to the intravenous sedative agent routinely used in the participating ICU (such as midazolam, propofol, or dexmedetomidine
- Medical history of malignant hyperthermia
- Long QT syndrome at risk of arrhythmic events
- Medical history of liver disease attributed to previous exposure to a halogenated agent (including sevoflurane)
- Suspected or proven intracranial hypertension
- Enrollment in another interventional trial with direct impact on oxygenation
- Patient under judicial protection, guardianship or supervision
- Patient under psychiatric care as defined by art. L1121-6 of the Public Health Code
- Known pregnancy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.