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Can a common anesthetic help ARDS patients breathe easier?

NCT ID NCT04235608

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using sevoflurane (an inhaled anesthetic) for sedation could lower death rates and shorten time on a ventilator in patients with acute respiratory distress syndrome (ARDS). 700 adults were randomly assigned to receive either sevoflurane or standard propofol sedation. The goal was to see if sevoflurane improves outcomes like days alive and off the ventilator.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sevoflurane (inhaled anesthetic)
What this could lead to
If it works, this could offer a better sedation method for ARDS patients, potentially reducing time on a ventilator and improving survival.
What could go wrong
This is a completed Phase 3 trial, but results are not yet widely known. The benefit may be small or not apply to all ARDS patients. Inhaled sedation also requires special equipment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

700 people

The number who actually took part.

Started

May 2020

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Presence for ≤24 hours of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms: * PaO2/FiO2 \<150 mmHg with positive end-expiratory pressure (PEEP) ≥8 cmH2O (or, if arterial blood gas not available, SpO2/FiO2 that is equivalent to a PaO2/FiO2 \<150 mmHg with PEEP ≥8 cmH2O and a confirmatory SpO2/FiO2 between 1-6 hours after the initial SpO2/FiO2 determination) * Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules * Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present Exclusion Criteria: * Absence of affiliation to the French Sociale security * Patient under a tutelage measure or placed under judicial protection * Continuous sedation with inhaled sevoflurane at enrollment * Known pregnancy * Currently receiving ECMO therapy * Chronic respiratory failure defined as PaCO2 \>60 mmHg in the outpatient setting * Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep-disordered breathing * Body mass index \>40 kg/m2 * Chronic liver disease defined as a Child-Pugh score of 12-15 * Expected duration of mechanical ventilation \<48 hours * Moribund patient, i.e. not expected to survive 24 hours despite intensive care * Burns \>70% total body surface * Previous hypersensitivity or anaphylactic reaction to sevoflurane or cisatracurium * 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) * Known hypersensitivity to propofol or any of its components * Known allergy to eggs, egg products, soybeans, and soy products * Suspected or proven intracranial hypertension * Tidal volume of 6 mL/kg predicted body weight (PBW) below 200 mL (as recommended by the manufacturer for the use of the AnaConDa-S (Sedana Medical, Danderyd, Sweden) * Enrollment in another interventional ARDS trial with direct impact on sedation and mechanical ventilation * Endotracheal ventilation for greater than 120 hours (5 days) * Persistent bronchopleural fistula despite chest tube drainage * PaO2/FiO2 (if available) \>200 mmHg after meeting inclusion criteria and before randomization

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Carémeaux Hospital - University Hospita

    Nîmes, France

  • Cavale Blanche Hospital - University Hospital

    Brest, France

  • Diaconesses - La Croix Simon Hospital

    Paris, France

  • Hautepierre Hospital, University Hospitals

    Strasbourg, France

  • Hospital

    Béthune, France

  • Hospital

    Cannes, France

  • Hospital

    Dunkirk, France

  • Hospital

    Melun, 77000, France

  • Hospital

    Saint-Brieuc, France

  • Hospital

    Saintes, France

  • Hospital Belfort

    Belfort, France

  • Hospital Chartres

    Chartres, France

  • Hospital Martigues

    Martigues, France

  • Hospital Saint-Nazaire

    Saint-Nazaire, France

  • Hospital Valenciennes

    Valenciennes, France

  • Hotel Dieu Hospital - University Hospital

    Nantes, France

  • Jean Perrin Comprehensive Cancer Center

    Clermont-Ferrand, France

  • Lapeyronie Hospital - University Hospital

    Montpellier, France

  • Pasteur 2 Hospital - University Hospital

    Nice, France

  • Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux

    Paris, France

  • Saint-Antoine University Hospital - Assistance Publique-Hôpitaux

    Paris, France

  • Saint-Eloi Hospital - University Hospital

    Montpellier, France

  • Saint-Louis University Hospital - Assistance Publique-Hôpitaux

    Paris, France

  • Salengro Hospital - University Hospital

    Lille, France

  • Timone Hospital - Assistance Publique-Hôpitaux

    Marseille, France

  • University Hospital

    Amiens, France

  • University Hospital

    Angers, France

  • University Hospital

    Clermont-Ferrand, France

  • University Hospital

    Dijon, France

  • University Hospital

    Poitiers, France

  • University Hospital

    Reims, France

  • University Hospital

    Rennes, France

  • University Hospital,

    Clermont-Ferrand, 63011, France

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