Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2020-05-03
2024-10-02
Brief Summary
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Half of the patients will receive inhaled sedation with sevoflurane and the other half will receive intravenous sedation with propofol.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Finally, the independent trial statistician and the members of the data monitoring and safety committee (DMSC) will also remain blinded for the allocation during analysis. However, the observation of differences in serious adverse events between the two groups will allow, for safety reasons may the DMSC deem necessary, to unblind allocation groups.
Study Groups
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inhaled sedation with sevoflurane
Inhaled sedation with sevoflurane, as vaporized via the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden)
Inhaled sedation with sevoflurane
Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden).
intravenous sedation with propofol
intravenous sedation with propofol, as already routinely used in participating ICUs
intravenous sedation with propofol
intravenous sedation with propofol, as already routinely used in participating ICUs.
Interventions
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Inhaled sedation with sevoflurane
Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden).
intravenous sedation with propofol
intravenous sedation with propofol, as already routinely used in participating ICUs.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Matthieu Jabaudon
Role: STUDY_CHAIR
University Hospital, Clermont-Ferrand
Raïko Blondonnet
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Jean-Michel Constantin
Role: PRINCIPAL_INVESTIGATOR
APHP - La Pitié Salpêtrière
Antoine Roquilly
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Samir Jaber
Role: PRINCIPAL_INVESTIGATOR
CHU Montpellier - Saint-Eloi
Virginie Lemiale
Role: PRINCIPAL_INVESTIGATOR
APHP - Saint-Louis
Carole Ichai
Role: PRINCIPAL_INVESTIGATOR
CHU NICE
Lionel Velly
Role: PRINCIPAL_INVESTIGATOR
APHM - La Timone
Stéphanie Bulyez
Role: PRINCIPAL_INVESTIGATOR
CHU Nîmes
Sigismond Lasocki
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Angers
Jean-Pierre Quenot
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Thomas Lebouvier
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
François Legay
Role: PRINCIPAL_INVESTIGATOR
CH Brieuc
Arnaud W. Thille
Role: PRINCIPAL_INVESTIGATOR
CHU Poitiers
Alexandre Lautrette
Role: PRINCIPAL_INVESTIGATOR
Centre Jean-Perrin Clermont-Ferrand
Julien Pottecher
Role: PRINCIPAL_INVESTIGATOR
CHU Strasbourg
Franck Verdonk
Role: PRINCIPAL_INVESTIGATOR
APHP - Saint-Antoine
Christophe Vinsonneau
Role: PRINCIPAL_INVESTIGATOR
CH Béthune
Pierre-Marie Bertrand
Role: PRINCIPAL_INVESTIGATOR
CH Cannes
Mehran Monchi
Role: PRINCIPAL_INVESTIGATOR
CH Melun-Sénart
Joël Cousson
Role: PRINCIPAL_INVESTIGATOR
CHU REIMS
Julien Maizel
Role: PRINCIPAL_INVESTIGATOR
CHU Amiens
Erwan L'Her
Role: PRINCIPAL_INVESTIGATOR
CHU Brest
Belaïd Bouhemad
Role: PRINCIPAL_INVESTIGATOR
CHU Dijon
Boris Jung
Role: PRINCIPAL_INVESTIGATOR
CHU Montpellier - Lapeyronie
Claire Dahyot-Fizelier
Role: PRINCIPAL_INVESTIGATOR
CHU Poitiers
Claire Lhommet
Role: PRINCIPAL_INVESTIGATOR
Hopital Diaconesses - La Croix Simon
Caroline Varillon
Role: PRINCIPAL_INVESTIGATOR
CH Dunkerque
Arthur Durand
Role: PRINCIPAL_INVESTIGATOR
CHU Lille
Marc Gainnier
Role: PRINCIPAL_INVESTIGATOR
APHM - La Timone
Fabien Lambiotte
Role: PRINCIPAL_INVESTIGATOR
Hospital Valenciennes
Julien Lorber
Role: PRINCIPAL_INVESTIGATOR
Hospital, Saint Nazaire
Delphine Brégeaud
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL, SAINTES
Aziz Berrouba
Role: PRINCIPAL_INVESTIGATOR
Hospital Martigues
Julio Badie
Role: PRINCIPAL_INVESTIGATOR
Hospital Belfort
Alexandre Conia
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL, CHARTRES
François Thouy
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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University Hospital
Amiens, , France
University Hospital
Angers, , France
Hospital Belfort
Belfort, , France
Hospital
Béthune, , France
Cavale Blanche Hospital - University Hospital
Brest, , France
Hospital
Cannes, , France
Hospital Chartres
Chartres, , France
University Hospital,
Clermont-Ferrand, , France
Jean Perrin Comprehensive Cancer Center
Clermont-Ferrand, , France
University Hospital
Clermont-Ferrand, , France
University Hospital
Dijon, , France
Hospital
Dunkirk, , France
Salengro Hospital - University Hospital
Lille, , France
Timone Hospital - Assistance Publique-Hôpitaux
Marseille, , France
Hospital Martigues
Martigues, , France
Hospital
Melun, , France
Lapeyronie Hospital - University Hospital
Montpellier, , France
Saint-Eloi Hospital - University Hospital
Montpellier, , France
Hotel Dieu Hospital - University Hospital
Nantes, , France
Pasteur 2 Hospital - University Hospital
Nice, , France
Carémeaux Hospital - University Hospita
Nîmes, , France
Diaconesses - La Croix Simon Hospital
Paris, , France
Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux
Paris, , France
Saint-Antoine University Hospital - Assistance Publique-Hôpitaux
Paris, , France
Saint-Louis University Hospital - Assistance Publique-Hôpitaux
Paris, , France
University Hospital
Poitiers, , France
University Hospital
Reims, , France
University Hospital
Rennes, , France
Hospital
Saint-Brieuc, , France
Hospital Saint-Nazaire
Saint-Nazaire, , France
Hospital
Saintes, , France
Hautepierre Hospital, University Hospitals
Strasbourg, , France
Hospital Valenciennes
Valenciennes, , France
Countries
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References
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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.
Other Identifiers
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SESAR - RBHP 2018 JABAUDON
Identifier Type: -
Identifier Source: org_study_id
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