Using inhaled sevoflurane to prevent Acute Respiratory Distress Syndrome
Randomized Clinical Trial of Inhaled Sedation With Sevoflurane in Critically Ill Patients at Risk of Developing the Acute Respiratory Distress Syndrome
This study is testing if using inhaled sevoflurane can help prevent Acute Respiratory Distress Syndrome in patients at high risk by improving lung function compared to standard sedation methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand, Not Required For This Country) |
| Trial ID | NCT05849779 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of inhaled sevoflurane as a sedation method for patients at high risk of developing Acute Respiratory Distress Syndrome (ARDS). It compares the effects of inhaled sevoflurane with standard intravenous sedation practices in improving lung function during ICU admission. The primary goal is to assess whether inhaled sevoflurane can enhance gas exchange and reduce pulmonary inflammation, potentially preventing the onset of ARDS. Participants will be monitored for improvements in their PaO2/FiO2 ratios, a key indicator of respiratory function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are admitted to ICUs with known risk factors for ARDS and require sedation for at least four hours.
Not a fit: Patients who are already experiencing ARDS or have been on mechanical ventilation for more than 24 hours prior to randomization will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of ARDS in at-risk patients, improving their overall respiratory health and outcomes.
How similar studies have performed: While the use of inhaled anesthetics for respiratory conditions is an emerging area, this specific approach with sevoflurane for ARDS prevention is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 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 interventional trial with direct impact on oxygenation
Where this trial is running
Clermont-Ferrand, Not Required For This Country
- CHU Clermont-Ferrand — Clermont-Ferrand, Not Required For This Country, France (Recruiting)
Study contacts
- Principal investigator: Matthieu JABAUDON — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: llaclautre_perrier@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.