A Phase 3 interventional study of Inhaled sedation with sevoflurane and Intravenous sedation (current practice) in Acute Respiratory Distress Syndrome, sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Treatment
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.
MAIN OBJECTIVE 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.
HYPOTHESIS The investigators hypothesized that a strategy of inhaled sedation with sevoflurane could be more effective than current intravenous sedation practice at improving pulmonary function during the early days of ICU admission, in patients at risk of ARDS.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 80 is above 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:
Sevoflurane as vaporized via the Anesthesia Conserving Device (Sedaconda-ACD-S, Sedana Medical, Danderyd, Sweden).
Drug: Inhaled sedation with sevoflurane
The investigators will not mandate the sedative type, but rather encourage the use of sedatives that are already routinely used in participating ICUs (typically a benzodiazepine, propofol, or dexmedetomidine, i.e. drugs approved for sedation).
Drug: Intravenous sedation (current practice)
In both arms, the management of sedation will be conducted in the broader picture of ICU patient care, as per current standard practice in participating ICUs, and following the current guidelines for Pain, Agitation, Delirium, Immobility, and Sleep Disruption (PADIS) published in 2018 by the Society of Critical Care Medicine. Among many recommendations, this will include the monitoring and titration of both sedation and analgesia using validated scores such as the Richmond Agitation-Sedation Scale (RASS) for sedation. As a result of the current recommendations, the level, dose, and duration of sedation will vary among patients and will be decided by the treating clinicians. The choice of the analgesic drug(s) will be as per the treating clinicians. Other aspects of critical care will adhere to standard care, including the use of the "Checklist for Lung Injury Prevention" (CLIP).
Also known as: Experimental
In both arms, the management of sedation will be conducted in the broader picture of ICU patient care, as per current standard practice in participating ICUs, and following the current guidelines for Pain, Agitation, Delirium, Immobility, and Sleep Disruption (PADIS) published in 2018 by the Society of Critical Care Medicine. Among many recommendations, this will include the monitoring and titration of both sedation and analgesia using validated scores such as the Richmond Agitation-Sedation Scale (RASS) for sedation. As a result of the current recommendations, the level, dose, and duration of sedation will vary among patients and will be decided by the treating clinicians. The choice of the analgesic drug(s) will be as per the treating clinicians. Other aspects of critical care will adhere to standard care, including the use of the "Checklist for Lung Injury Prevention" (CLIP).
Also known as: Control
PaO2/FiO2 ratio
longitudinal evolution in the PaO2/FiO2 ratio
Time frame: within 5 days from randomization
Progression to ARDS
Progression to ARDS will be assessed according to the Berlin criteria, including chest radiographs
Time frame: within 5 days from randomization
Rate of pneumonia
Pneumonia will be defined according to the 3 following criteria: * Two chest radiographs showing signs of pneumonia, or one in absence of cardiomyopathy or underlying pulmonary condition. * One item among: body temperature ≥38.3°C without evident cause, leukocytes \<4000/mm3 or ≥12000/mm3 * Two items among: purulent secretions, cough or dyspnea, increased need for oxygen supplementation or ventilatory assistance.
Time frame: Presence of pneumonia will be assessed daily until Day 5, and at Day 28 or ICU discharge, whichever comes first.
Ventilator-free days to day 28
Ventilator free days to day 28 are defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a patient returns to assisted breathing and subsequently achieves unassisted breathing to day 28, VFDs will be counted from the end of the last period of assisted breathing to day 28. A period of assisted breathing lasting less than 24 hours and for the purpose of a surgical procedure will not count against the VFD calculation. If a patient was receiving assisted breathing at day 27 or dies prior to day 28, VFDs will be zero.
Time frame: 28 days after randomization
Organ failure to day 5
Organ failure is defined as present when the most abnormal vital signs or clinically available lab value meets the definition of clinically significant organ failure according to SOFA scores. Patients will be followed daily from randomization to day 5 for development of organ failures.
Time frame: 5 days after randomization
Mortality at day 28
The occurrence of death in the ICU will be recorded until day 28.
Time frame: 28 days after randomization
Length of ICU-stay up to 28 days
The total number of days from admission to ICU discharge will be recorded until day 28
Time frame: 28 days after randomization
Physiological measures: Oxygenation
- Oxygenation Index on study days 1-5
Time frame: 28 days after randomization
Physiological measures: PaCO2
- PaCO2 on study days 1-5
Time frame: 28 days after randomization
Physiological measures: pH
- Arterial pH on study days 1-5
Time frame: 28 days after randomization
Physiological measures: PEEP
- Level of PEEP (and static auto-PEEP in patients under controlled ventilation) on study days 1-5
Time frame: 28 days after randomization
Physiological measures: Plateau pressure
- Plateau pressure, static compliance of the respiratory system on study day 1-5
Time frame: 28 days after randomization
Physiological measures: Pneumothorax
- Development of pneumothorax through day 28
Time frame: 28 days after randomization
Physiological measures: Switch from controlled to pressure-support ventilation
- Time to switching from controlled to pressure-support ventilation through day 5
Time frame: 28 days after randomization
Physiological measures: Airway occlusion pressure
- Airway occlusion pressure at 0.1 s (P0.1), an index of respiratory drive, on the day the patient is switched to pressure-support ventilation if within 5 days since randomization
Time frame: 28 days after randomization
Hemodynamic measures
- Hemodynamic measures (mean arterial pressure, dose of infused norepinephrine or other vasopressor, serum lactate level) on study days 1-5
Time frame: 28 days after randomization
Physiological measures: Acute kidney injury
- KDIGO criteria for acute kidney injury 24 through day 5
Time frame: 28 days after randomization
Physiological measures: Supraventricular tachycardia
- Supraventricular tachycardia (SVT) or new onset atrial fibrillation through day 5
Time frame: 28 days after randomization
ICU-acquired delirium
The Confusion Assessment Method for the ICU (CAM-ICU, Appendix C )97 will be assessed daily from study entry to study day 28, death or ICU discharge, whichever comes first.
Time frame: 28 days after randomization
Biomarker measurements
Plasma samples will be collected from indwelling catheters (when available) at study entry and on days 1, 2, 3, 4, 5 in order to assemble a biological collection aimed at further investigating the effects of inhaled sedation with sevoflurane in patients with ARDS. The investigators will also collect whole blood samples at study entry and on day 2 for future studies of macrophage activation profiles and RNA and DNA studies.
Time frame: from inclusion to 5 days
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University Hospital, Clermont-Ferrand