SEvoflurane for Sedation in ARds

NCT04235608 | Completed Phase 3 DMC

• 1 other identifier: SESAR - RBHP 2018 JABAUDON
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 33

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Sedation; Inhaled sevoflurane

Outcome Measures

Primary Outcomes (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

  Day 28

Secondary Outcomes (5)

• 90-day survival (Key secondary outcome)

  Day 90

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

  Day 28

• All-cause hospital 28-day mortality (Secondary outcome)

  Day 28

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

  Day 14

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

  Day 7

Other Outcomes (49)

• Ventilator-free days through day 14 (Exploratory outcome)

  Day 14

• Ventilator-free days through day 7 (Exploratory outcome)

  Day 7

• Organ failure-free days through day 7 (Exploratory outcome)

  Day 7

Study Arms (2)

inhaled sedation with sevoflurane

EXPERIMENTAL

Inhaled sedation with sevoflurane, as vaporized via the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden)

Drug: Inhaled sedation with sevoflurane

intravenous sedation with propofol

ACTIVE COMPARATOR

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

Drug: intravenous sedation with propofol

Interventions

Inhaled sedation with sevoflurane DRUG

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

inhaled sedation with sevoflurane

intravenous sedation with propofol DRUG

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

intravenous sedation with propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (33)

University Hospital

Amiens, France

Location

University Hospital

Angers, France

Location

Hospital Belfort

Belfort, France

Location

Hospital

Béthune, France

Location

Cavale Blanche Hospital - University Hospital

Brest, France

Location

Hospital

Cannes, France

Location

Hospital Chartres

Chartres, France

Location

University Hospital,

Clermont-Ferrand, 63011, France

Location

Jean Perrin Comprehensive Cancer Center

Clermont-Ferrand, France

Location

University Hospital

Clermont-Ferrand, France

Location

University Hospital

Dijon, France

Location

Hospital

Dunkirk, France

Location

Salengro Hospital - University Hospital

Lille, France

Location

Timone Hospital - Assistance Publique-Hôpitaux

Marseille, France

Location

Hospital Martigues

Martigues, France

Location

Hospital

Melun, 77000, France

Location

Lapeyronie Hospital - University Hospital

Montpellier, France

Location

Saint-Eloi Hospital - University Hospital

Montpellier, France

Location

Hotel Dieu Hospital - University Hospital

Nantes, France

Location

Pasteur 2 Hospital - University Hospital

Nice, France

Location

Carémeaux Hospital - University Hospita

Nîmes, France

Location

Diaconesses - La Croix Simon Hospital

Paris, France

Location

Pitié-Salpêtrière Hospital, - Assistance Publique-Hôpitaux

Paris, France

Location

Saint-Antoine University Hospital - Assistance Publique-Hôpitaux

Paris, France

Location

Saint-Louis University Hospital - Assistance Publique-Hôpitaux

Paris, France

Location

University Hospital

Poitiers, France

Location

University Hospital

Reims, France

Location

University Hospital

Rennes, France

Location

Hospital

Saint-Brieuc, France

Location

Hospital Saint-Nazaire

Saint-Nazaire, France

Location

Hospital

Saintes, France

Location

Hautepierre Hospital, University Hospitals

Strasbourg, France

Location

Hospital Valenciennes

Valenciennes, France

Location

Related Publications (1)

• 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.

  PMID: 40098564 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Matthieu Jabaudon

  University Hospital, Clermont-Ferrand

  STUDY CHAIR

• Raïko Blondonnet

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Jean-Michel Constantin

  APHP - La Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

• Antoine Roquilly

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Samir Jaber

  CHU Montpellier - Saint-Eloi

  PRINCIPAL INVESTIGATOR

• Virginie Lemiale

  APHP - Saint-Louis

  PRINCIPAL INVESTIGATOR

• Carole Ichai

  CHU NICE

  PRINCIPAL INVESTIGATOR

• Lionel Velly

  APHM - La Timone

  PRINCIPAL INVESTIGATOR

• Stéphanie Bulyez

  CHU Nîmes

  PRINCIPAL INVESTIGATOR

• Sigismond Lasocki

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Quenot

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Thomas Lebouvier

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• François Legay

  CH Brieuc

  PRINCIPAL INVESTIGATOR

• Arnaud W. Thille

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• Alexandre Lautrette

  Centre Jean-Perrin Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• Julien Pottecher

  CHU Strasbourg

  PRINCIPAL INVESTIGATOR

• Franck Verdonk

  APHP - Saint-Antoine

  PRINCIPAL INVESTIGATOR

• Christophe Vinsonneau

  CH Béthune

  PRINCIPAL INVESTIGATOR

• Pierre-Marie Bertrand

  CH Cannes

  PRINCIPAL INVESTIGATOR

• Mehran Monchi

  CH Melun-Sénart

  PRINCIPAL INVESTIGATOR

• Joël Cousson

  CHU REIMS

  PRINCIPAL INVESTIGATOR

• Julien Maizel

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Erwan L'Her

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Belaïd Bouhemad

  CHU Dijon

  PRINCIPAL INVESTIGATOR

• Boris Jung

  CHU Montpellier - Lapeyronie

  PRINCIPAL INVESTIGATOR

• Claire Dahyot-Fizelier

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• Claire Lhommet

  Hopital Diaconesses - La Croix Simon

  PRINCIPAL INVESTIGATOR

• Caroline Varillon

  CH Dunkerque

  PRINCIPAL INVESTIGATOR

• Arthur Durand

  CHU Lille

  PRINCIPAL INVESTIGATOR

• Marc Gainnier

  APHM - La Timone

  PRINCIPAL INVESTIGATOR

• Fabien Lambiotte

  Hospital Valenciennes

  PRINCIPAL INVESTIGATOR

• Julien Lorber

  Hospital, Saint Nazaire

  PRINCIPAL INVESTIGATOR

• Delphine Brégeaud

  HOSPITAL, SAINTES

  PRINCIPAL INVESTIGATOR

• Aziz Berrouba

  Hospital Martigues

  PRINCIPAL INVESTIGATOR

• Julio Badie

  Hospital Belfort

  PRINCIPAL INVESTIGATOR

• Alexandre Conia

  HOSPITAL, CHARTRES

  PRINCIPAL INVESTIGATOR

• François Thouy

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At each participating center, patients will be followed up for primary and secondary endpoints by members of the research staff who will be unaware of the trial group allocation. Information on whether the primary and secondary outcomes occur will be collected and entered into the electronic web-based case report form (eCRF) by trial or clinical trained personal (clinical research associate), blinded to the allocation group, under the supervision of the local principal investigator (PI) or designee who will also be unaware of the trial group allocation. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 22, 2020
• Study Start: May 3, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 2, 2024
• Last Updated: April 21, 2026

Record last verified: 2024-06

Locations

FR (33)