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Acute Respiratory Distress SyndromePhase 3SESARNCT04235608

SEvoflurane for Sedation in ARds

A Phase 3 study testing Inhaled sedation with sevoflurane and intravenous sedation with propofol in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 33 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates whether a sedation with inhaled sevoflurane will decrease mortality and increase time off the ventilator at 28 days in patients with acute respiratory distress syndrome (ARDS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
Inhaled sedation with sevoflurane and intravenous sedation with propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
33 sitesFrance
Study dates
3 May 2020to 2 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

France33 sites

  • University Hospital

    Amiens

  • University Hospital

    Angers

  • Hospital Belfort

    Belfort

  • Hospital

    Béthune

  • Cavale Blanche Hospital - University Hospital

    Brest

  • Hospital

    Cannes

  • Hospital Chartres

    Chartres

  • University Hospital,

    Clermont-Ferrand, 63011

  • Jean Perrin Comprehensive Cancer Center

    Clermont-Ferrand

  • University Hospital

    Clermont-Ferrand

  • University Hospital

    Dijon

  • Hospital

    Dunkirk

  • Salengro Hospital - University Hospital

    Lille

  • Timone Hospital - Assistance Publique-Hôpitaux

    Marseille

  • Hospital Martigues

    Martigues

  • Hospital

    Melun, 77000

  • Lapeyronie Hospital - University Hospital

    Montpellier

  • Saint-Eloi Hospital - University Hospital

    Montpellier

  • Hotel Dieu Hospital - University Hospital

    Nantes

  • Pasteur 2 Hospital - University Hospital

    Nice

  • Carémeaux Hospital - University Hospita

    Nîmes

  • Diaconesses - La Croix Simon Hospital

    Paris

  • Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux

    Paris

  • Saint-Antoine University Hospital - Assistance Publique-Hôpitaux

    Paris

  • Saint-Louis University Hospital - Assistance Publique-Hôpitaux

    Paris

  • University Hospital

    Poitiers

  • University Hospital

    Reims

  • University Hospital

    Rennes

  • Hospital

    Saint-Brieuc

  • Hospital Saint-Nazaire

    Saint-Nazaire

  • Hospital

    Saintes

  • Hautepierre Hospital, University Hospitals

    Strasbourg

  • Hospital Valenciennes

    Valenciennes

Other trials in France

About this study

Official title: Sevoflurane for Sedation in Acute Respiratory Distress Syndrome: A Multicenter Prospective Randomized Trial

This study evaluates whether a sedation with inhaled sevoflurane will decrease mortality and increase time off the ventilator at 28 days in patients with acute respiratory distress syndrome (ARDS).

Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation with propofol.

Read the detailed description

PRIMARY OBJECTIVE:

To assess the efficacy of a sedation with inhaled sevoflurane in improving in reducing mortality and morbidity in patients with moderate-severe ARDS in comparison to a control group receiving intravenous sedation with propofol.

PRIMARY HYPOTHESIS:

Inhaled sedation with sevoflurane will improve a composite outcome of mortality and time off the ventilator at 28 days, in patients with moderate-severe ARDS.

The trial will accrue a maximum of 700 patients. Patients will be recruited from participating intensive care units and randomized to the active (inhaled sevoflurane) or control (intravenous propofol).

The overall strategy is to screen and enroll early, every newly intubated, acutely ill or postoperative, patient at each site, using clinically obtained pulse oximetry and blood gases.

By providing superior awakening and extubation times, as well as lung-protective effects from anti-inflammatory and protective effects from epithelial injury, inhaled sevoflurane may hasten recovery from lung injury and improve outcomes.

Being tested
Inhaled sedation with sevoflurane, intravenous sedation with propofol
Keywords
ARDS, Sedation, Inhaled sevoflurane
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inhaled sedation with sevofluraneDrug

    Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden).

  • intravenous sedation with propofolDrug

    intravenous sedation with propofol, as already routinely used in participating ICUs.

Study groups in NCT04235608
Study groupRoleWhat they receive
inhaled sedation with sevofluraneExperimentalInhaled sedation with sevoflurane, as vaporized via the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden)
Receives: Drug: Inhaled sedation with sevoflurane
intravenous sedation with propofolActive comparatorintravenous sedation with propofol, as already routinely used in participating ICUs
Receives: Drug: intravenous sedation with propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilator-free days through day 28

    Number of days alive and off the ventilator at 28 days, thereby considering death as a competing event

    Measured: Day 28

Secondary outcomes (5)

  1. 90-day survival (Key secondary outcome)

    Measured: Day 90

  2. All-cause, all-location 28-day mortality (Secondary outcome)

    Measured: Day 28

  3. All-cause hospital 28-day mortality (Secondary outcome)

    Measured: Day 28

  4. All-cause, all-location 14-day mortality (Secondary outcome)

    Measured: Day 14

  5. All-cause, all-location 7-day mortality (Secondary outcome)

    Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start3 May 2020
  3. Primary completion31 Oct 2023
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Investigator-initiated, multicenter, prospective, randomized, stratified, parallel-group clinical trial with blinded outcome assessment and concealed allocation of patients with moderate-to-severe ARDS to a strategy of inhaled sedation with sevoflurane or to a strategy of current intravenous sedation practice using propofol.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04235608
Sponsor's protocol ID
SESAR - RBHP 2018 JABAUDON
Acronym
SESAR
Status last verified
Jun 2024
First submitted
14 Jan 2020
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jabaudon M, Quenot JP, Badie J, Audard J, Jaber S, Rieu B, Varillon C, Monsel A, Thouy F, Lorber J, Cousson J, Bulyez S, Bourenne J, Sboui G, Lhommet C, Lemiale V, Bouhemad B, Brault C, Lasocki S, Legay F, Lebouvier T, Durand A, Pottecher J, Conia A, Bregeaud D, Velly L, Thille AW, Lambiotte F, L'Her E, Monchi M, Roquilly A, Berrouba A, Verdonk F, Chabanne R, Godet T, Garnier M, Blondonnet R, Vernhes J, Sapin V, Borao L, Futier E, Pereira B, Constantin JM; SESAR Trial Investigators. Inhaled Sedation in Acute Respiratory Distress Syndrome: The SESAR Randomized Clinical Trial. JAMA. 2025 May 13;333(18):1608-1617. doi: 10.1001/jama.2025.3169.

    PubMed 40098564

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inhaled sedation with sevoflurane and intravenous sedation with propofol in people with Acute Respiratory Distress Syndrome, run by University Hospital, Clermont-Ferrand at 33 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilator-free days through day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04235608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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SEvoflurane for Sedation in ARds (NCT04235608) | AzTrials