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A Study of Inhaled Sevoflurane Compared to Standard Intravenous Sedation (Dexmedetomidine, Midazolam, or Propofol) in ICU Patients at Risk of Acute Respiratory Distress Syndrome

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients in Intensive Care Unit (ICU) who are at risk of developing Acute Respiratory Distress Syndrome (ARDS), a serious lung condition that makes it difficult to breathe. The main treatment being studied is sevoflurane, a medication that is inhaled as a vapor, compared to standard medications given through a vein for keeping patients calm and comfortable while on a breathing machine.

The purpose of the study is to determine if inhaled sevoflurane can improve oxygen levels in the blood better than traditional medications. The other medications that may be used in the study include dexmedetomidine, cisatracurium, midazolam, and propofol, which are all given through a vein. These medications are commonly used to help keep patients comfortable while they are receiving support from a breathing machine.

During the study, patients will receive either sevoflurane through a breathing system or the standard medications through their veins for up to 5 days. The doctors will monitor how well patients' lungs work by measuring oxygen levels and checking for signs of lung problems. They will also track other important health information such as infections, time spent on breathing machines, and length of stay in the intensive care unit.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and group assignment

    After meeting eligibility criteria, you will be randomly assigned to receive either inhaled sedation with sevoflurane or standard intravenous sedation

    Your medical condition requires you to be on a breathing machine (mechanical ventilation)

  2. Step 2

    Sedation administration

    If assigned to the inhaled group: you will receive sevoflurane through the breathing machine

    If assigned to the standard group: you will receive intravenous medications that may include dexmedetomidine, cisatracurium, midazolam, or propofol

    The sedation will continue for at least 4 hours, with duration based on your medical needs

  3. Step 3

    Monitoring and measurements

    Regular monitoring of oxygen levels in your blood

    Daily chest X-rays to check your lung condition

    Regular assessment of breathing function

    Monitoring for signs of pneumonia or other complications

    Assessment of mental status after intensive care

  4. Step 4

    Duration of participation

    Your participation continues throughout your stay in the intensive care unit (ICU)

    The length of stay will depend on your medical condition and recovery

    The study continues until July 2025

  5. Step 5

    Follow-up assessments

    Monitoring of recovery progress

    Recording the number of days without needing the breathing machine

    Tracking any complications or health issues that develop during the ICU stay

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You must be admitted to an Intensive Care Unit (ICU) with at least one known risk factor for Acute Respiratory Distress Syndrome (ARDS) and have a Lung Injury Prediction Score (LIPS) of 4 or higher
  • You must be receiving invasive mechanical ventilation (breathing support through a tube inserted into your airway)
  • You must require sedation (medications to keep you calm and comfortable) for at least 4 hours
  • You must be affiliated with the French Social Security system (Sécurité Sociale)
  • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Current diagnosis of Acute Respiratory Distress Syndrome (ARDS) - a severe lung condition that prevents enough oxygen from getting into the blood
  • Known allergic reactions to sevoflurane - an inhaled anesthetic medication
  • Severe liver disease or dysfunction
  • Uncontrolled high blood pressure
  • Recent major surgery (within the last 14 days)
  • Participation in other clinical trials within the past 30 days
  • History of malignant hyperthermia - a severe reaction to certain anesthetics
  • Severe kidney disease requiring dialysis
  • Unstable heart conditions
  • Brain injury or increased pressure in the brain
  • Mental conditions that prevent giving informed consent
  • Drug or alcohol dependency
  • Use of medications that might interact with sevoflurane
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Investigated drugs

  • Sevoflurane

    is an inhaled anesthetic medication used for sedation. It is given through breathing (inhalation) rather than through an IV line. In intensive care settings, it can help keep patients comfortable while they are on breathing support. This medication is being studied for its potential benefits in patients who are at risk of developing serious breathing problems in the ICU.

  • Standard intravenous sedatives

    are medications given through an IV line to keep patients comfortable and calm while they are in intensive care. These are the current standard medications used for sedation in most intensive care units.

What is already known about the treatment

Sevoflurane - A volatile anesthetic medication administered through inhalation, commonly used for sedation in intensive care settings. This fast-acting drug belongs to the halogenated ether group of anesthetics and works by enhancing inhibitory neurotransmission in the brain, specifically by modulating GABA receptors. Sevoflurane is particularly valuable in critical care medicine for patients at risk of Acute Respiratory Distress Syndrome (ARDS) due to its bronchodilating properties and rapid onset and offset of action, allowing for better control of sedation levels. The medication is delivered through specialized vaporizer systems and can be precisely titrated to achieve the desired level of sedation while potentially offering protective effects on lung function.

Investigated diseases

  • Acute Respiratory Distress Syndrome (ARDS)

    A severe lung condition that develops rapidly when fluid builds up in the tiny air sacs in the lungs. This fluid prevents the lungs from filling with enough air, resulting in less oxygen reaching the bloodstream. The condition typically develops in people who are already critically ill or who have significant injuries. ARDS can occur following infection, trauma, or inhalation of harmful substances. The condition causes breathing difficulties, rapid breathing, and a bluish skin coloration. The lungs become stiff and heavy as inflammation and fluid accumulation progress.

  • Hospital-Acquired Pneumonia

    An infection of the lungs that develops during a hospital stay, typically 48 hours or more after admission. It occurs when bacteria enter the lungs, often due to mechanical ventilation or prolonged bed rest. The infection causes inflammation in the air sacs of the lungs, leading to cough, fever, and difficulty breathing. This condition is distinct from community-acquired pneumonia as it involves different types of bacteria and develops in a healthcare setting.

  • ICU-Acquired Delirium

    A serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment, specifically occurring during an intensive care unit stay. It can develop over a few hours or days and is characterized by changes in consciousness, disorganized thinking, and disorientation. Patients may experience hallucinations, altered sleep-wake cycles, and changes in behavior. This temporary condition can fluctuate throughout the day.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517670-15-00Protocol codeAOI 2019 JABAUDONEstimated enrolment80 patientsSponsorCHU Gabriel-Montpied

sourced from the EU Clinical Trials Register and site verification

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