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Prevention study for Acute Respiratory Distress Syndrome
Official title Inhaled Sevoflurane for ARDS Prevention
ClinicalTrials.gov ID: NCT05849779
What this study is testing
What is Inhaled sedation with sevoflurane?
Inhaled sedation with sevoflurane is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome.
Also referred to as Experimental.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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 (Appendix D)105
- 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 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
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 (Appendix D)105
- Patient under invasive mechanical ventilation
- With expected duration of sedation superior or equal to 4 hours
- Affiliation to the French Sécurité Sociale
- 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 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)
- Absolute contra-indications to the intravenous sedation 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 treatment trial with direct impact on oxygenation
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, Not Required For This Country, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, Not Required For This Country, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.