Matthieu Jabaudon, Jean-Pierre Quenot, Julio Badie, Jules Audard, Samir Jaber, Benjamin Rieu, Caroline Varillon, Antoine Monsel, François Thouy, Julien Lorber, Joël Cousson, Stéphanie Bulyez, Jérémy Bourenne, Ghada Sboui, Claire Lhommet, Virginie Lemiale, Belaïd Bouhemad, Clément Brault, Sigismond Lasocki, François Legay, Thomas Lebouvier, Arthur Durand, Julien Pottecher, Alexandre Conia, Delphine Brégeaud, Lionel Velly, Arnaud W Thille, Fabien Lambiotte, Erwan L'Her, Mehran Monchi, Antoine Roquilly, Aziz Berrouba, Franck Verdonk, Russell Chabanne, Thomas Godet, Marc Garnier, Raiko Blondonnet, Jérémy Vernhes, Vincent Sapin, Lucile Borao, Emmanuel Futier, Bruno Pereira, Jean-Michel Constantin
{"title":"吸入镇静治疗急性呼吸窘迫综合征：SESAR随机临床试验","authors":"Matthieu Jabaudon, Jean-Pierre Quenot, Julio Badie, Jules Audard, Samir Jaber, Benjamin Rieu, Caroline Varillon, Antoine Monsel, François Thouy, Julien Lorber, Joël Cousson, Stéphanie Bulyez, Jérémy Bourenne, Ghada Sboui, Claire Lhommet, Virginie Lemiale, Belaïd Bouhemad, Clément Brault, Sigismond Lasocki, François Legay, Thomas Lebouvier, Arthur Durand, Julien Pottecher, Alexandre Conia, Delphine Brégeaud, Lionel Velly, Arnaud W Thille, Fabien Lambiotte, Erwan L'Her, Mehran Monchi, Antoine Roquilly, Aziz Berrouba, Franck Verdonk, Russell Chabanne, Thomas Godet, Marc Garnier, Raiko Blondonnet, Jérémy Vernhes, Vincent Sapin, Lucile Borao, Emmanuel Futier, Bruno Pereira, Jean-Michel Constantin","doi":"10.1001/jama.2025.3169","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>Whether the use of inhaled or intravenous sedation affects outcomes differentially in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) is unknown.</p><p><strong>Objective: </strong>To determine the efficacy and safety of inhaled sevoflurane compared with intravenous propofol for sedation in patients with ARDS.</p><p><strong>Design, setting, and participants: </strong>Phase 3 randomized, open-label, assessor-blinded clinical trial conducted from May 2020 to October 2023 with 90-day follow-up. Adults with early moderate to severe ARDS (defined by a ratio of Pao2 to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure of ≥8 cm H2O) were enrolled in 37 French intensive care units.</p><p><strong>Interventions: </strong>Patients were randomized to a strategy of inhaled sedation with sevoflurane (intervention group) or to a strategy of intravenous sedation with propofol (control group) for up to 7 days.</p><p><strong>Main outcomes and measures: </strong>The primary end point was the number of ventilator-free days at 28 days; the key secondary end point was 90-day survival.</p><p><strong>Results: </strong>Of 687 patients enrolled (mean [SD] age, 65 [12] years; 30% female), 346 were randomized to sevoflurane and 341 to propofol. The median total duration of sedation was 7 days (IQR, 4 to 7) in both groups. The number of ventilator-free days through day 28 was 0.0 days (IQR, 0.0 to 11.9) in the sevoflurane group and 0.0 days (IQR, 0.0 to 18.7) in the propofol group (median difference, -2.1 [95% CI, -3.6 to -0.7]; standardized hazard ratio, 0.76 [95% CI, 0.50 to 0.97]). The 90-day survival rates were 47.1% and 55.7% in the sevoflurane and propofol groups, respectively (hazard ratio, 1.31 [95% CI, 1.05 to 1.62]). Among 4 secondary outcomes, sevoflurane was associated with higher 7-day mortality (19.4% vs 13.5%, respectively; relative risk, 1.44 [95% CI, 1.02 to 2.03]) and fewer intensive care unit-free days through day 28 (median, 0.0 [IQR, 0.0 to 6.0] vs 0.0 [IQR, 0.0 to 15.0]; median difference, -2.5 [95% CI, -3.7 to -1.4]) compared with propofol.</p><p><strong>Conclusions and relevance: </strong>Among patients with moderate to severe ARDS, inhaled sedation with sevoflurane resulted in fewer ventilator-free days at day 28 and lower 90-day survival than sedation with propofol.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04235608.</p>","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"1608-1617"},"PeriodicalIF":55.0000,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920880/pdf/","citationCount":"0","resultStr":"{\"title\":\"Inhaled Sedation in Acute Respiratory Distress Syndrome: The SESAR Randomized Clinical Trial.\",\"authors\":\"Matthieu Jabaudon, Jean-Pierre Quenot, Julio Badie, Jules Audard, Samir Jaber, Benjamin Rieu, Caroline Varillon, Antoine Monsel, François Thouy, Julien Lorber, Joël Cousson, Stéphanie Bulyez, Jérémy Bourenne, Ghada Sboui, Claire Lhommet, Virginie Lemiale, Belaïd Bouhemad, Clément Brault, Sigismond Lasocki, François Legay, Thomas Lebouvier, Arthur Durand, Julien Pottecher, Alexandre Conia, Delphine Brégeaud, Lionel Velly, Arnaud W Thille, Fabien Lambiotte, Erwan L'Her, Mehran Monchi, Antoine Roquilly, Aziz Berrouba, Franck Verdonk, Russell Chabanne, Thomas Godet, Marc Garnier, Raiko Blondonnet, Jérémy Vernhes, Vincent Sapin, Lucile Borao, Emmanuel Futier, Bruno Pereira, Jean-Michel Constantin\",\"doi\":\"10.1001/jama.2025.3169\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>Whether the use of inhaled or intravenous sedation affects outcomes differentially in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) is unknown.</p><p><strong>Objective: </strong>To determine the efficacy and safety of inhaled sevoflurane compared with intravenous propofol for sedation in patients with ARDS.</p><p><strong>Design, setting, and participants: </strong>Phase 3 randomized, open-label, assessor-blinded clinical trial conducted from May 2020 to October 2023 with 90-day follow-up. Adults with early moderate to severe ARDS (defined by a ratio of Pao2 to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure of ≥8 cm H2O) were enrolled in 37 French intensive care units.</p><p><strong>Interventions: </strong>Patients were randomized to a strategy of inhaled sedation with sevoflurane (intervention group) or to a strategy of intravenous sedation with propofol (control group) for up to 7 days.</p><p><strong>Main outcomes and measures: </strong>The primary end point was the number of ventilator-free days at 28 days; the key secondary end point was 90-day survival.</p><p><strong>Results: </strong>Of 687 patients enrolled (mean [SD] age, 65 [12] years; 30% female), 346 were randomized to sevoflurane and 341 to propofol. The median total duration of sedation was 7 days (IQR, 4 to 7) in both groups. The number of ventilator-free days through day 28 was 0.0 days (IQR, 0.0 to 11.9) in the sevoflurane group and 0.0 days (IQR, 0.0 to 18.7) in the propofol group (median difference, -2.1 [95% CI, -3.6 to -0.7]; standardized hazard ratio, 0.76 [95% CI, 0.50 to 0.97]). The 90-day survival rates were 47.1% and 55.7% in the sevoflurane and propofol groups, respectively (hazard ratio, 1.31 [95% CI, 1.05 to 1.62]). Among 4 secondary outcomes, sevoflurane was associated with higher 7-day mortality (19.4% vs 13.5%, respectively; relative risk, 1.44 [95% CI, 1.02 to 2.03]) and fewer intensive care unit-free days through day 28 (median, 0.0 [IQR, 0.0 to 6.0] vs 0.0 [IQR, 0.0 to 15.0]; median difference, -2.5 [95% CI, -3.7 to -1.4]) compared with propofol.</p><p><strong>Conclusions and relevance: </strong>Among patients with moderate to severe ARDS, inhaled sedation with sevoflurane resulted in fewer ventilator-free days at day 28 and lower 90-day survival than sedation with propofol.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04235608.</p>\",\"PeriodicalId\":54909,\"journal\":{\"name\":\"Jama-Journal of the American Medical Association\",\"volume\":\" \",\"pages\":\"1608-1617\"},\"PeriodicalIF\":55.0000,\"publicationDate\":\"2025-05-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920880/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Jama-Journal of the American Medical Association\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jama.2025.3169\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Jama-Journal of the American Medical Association","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jama.2025.3169","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Inhaled Sedation in Acute Respiratory Distress Syndrome: The SESAR Randomized Clinical Trial.
Importance: Whether the use of inhaled or intravenous sedation affects outcomes differentially in mechanically ventilated adults with acute respiratory distress syndrome (ARDS) is unknown.
Objective: To determine the efficacy and safety of inhaled sevoflurane compared with intravenous propofol for sedation in patients with ARDS.
Design, setting, and participants: Phase 3 randomized, open-label, assessor-blinded clinical trial conducted from May 2020 to October 2023 with 90-day follow-up. Adults with early moderate to severe ARDS (defined by a ratio of Pao2 to the fraction of inspired oxygen of <150 mm Hg with a positive end-expiratory pressure of ≥8 cm H2O) were enrolled in 37 French intensive care units.
Interventions: Patients were randomized to a strategy of inhaled sedation with sevoflurane (intervention group) or to a strategy of intravenous sedation with propofol (control group) for up to 7 days.
Main outcomes and measures: The primary end point was the number of ventilator-free days at 28 days; the key secondary end point was 90-day survival.
Results: Of 687 patients enrolled (mean [SD] age, 65 [12] years; 30% female), 346 were randomized to sevoflurane and 341 to propofol. The median total duration of sedation was 7 days (IQR, 4 to 7) in both groups. The number of ventilator-free days through day 28 was 0.0 days (IQR, 0.0 to 11.9) in the sevoflurane group and 0.0 days (IQR, 0.0 to 18.7) in the propofol group (median difference, -2.1 [95% CI, -3.6 to -0.7]; standardized hazard ratio, 0.76 [95% CI, 0.50 to 0.97]). The 90-day survival rates were 47.1% and 55.7% in the sevoflurane and propofol groups, respectively (hazard ratio, 1.31 [95% CI, 1.05 to 1.62]). Among 4 secondary outcomes, sevoflurane was associated with higher 7-day mortality (19.4% vs 13.5%, respectively; relative risk, 1.44 [95% CI, 1.02 to 2.03]) and fewer intensive care unit-free days through day 28 (median, 0.0 [IQR, 0.0 to 6.0] vs 0.0 [IQR, 0.0 to 15.0]; median difference, -2.5 [95% CI, -3.7 to -1.4]) compared with propofol.
Conclusions and relevance: Among patients with moderate to severe ARDS, inhaled sedation with sevoflurane resulted in fewer ventilator-free days at day 28 and lower 90-day survival than sedation with propofol.
期刊介绍：
JAMA (Journal of the American Medical Association) is an international peer-reviewed general medical journal. It has been published continuously since 1883. JAMA is a member of the JAMA Network, which is a consortium of peer-reviewed general medical and specialty publications.
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