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":"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":"10.1001/jama.2025.3169","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":""},"PeriodicalIF":63.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11920880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Researchers Use Machine Learning to Put Older Clinical Guidelines to the Test.","authors":"Yulin Hswen, Rita Rubin","doi":"10.1001/jama.2024.28105","DOIUrl":"10.1001/jama.2024.28105","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"927-929"},"PeriodicalIF":63.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Achieving Education Equity Could End Maternal Heart Health Disparities.","authors":"Anna Bock","doi":"10.1001/jama.2025.0249","DOIUrl":"10.1001/jama.2025.0249","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"930-931"},"PeriodicalIF":63.1,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143416283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Regulation of Health and Health Care Artificial Intelligence.","authors":"Michelle M Mello, I Glenn Cohen","doi":"10.1001/jama.2025.3308","DOIUrl":"https://doi.org/10.1001/jama.2025.3308","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spontaneous Breathing Trial Techniques.","authors":"Luke Andrea, Abhishrut Jog, Ari Moskowitz","doi":"10.1001/jama.2024.28818","DOIUrl":"https://doi.org/10.1001/jama.2024.28818","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spontaneous Breathing Trial Techniques-Reply.","authors":"Karen E A Burns, Nicholas S Hill, Deborah J Cook","doi":"10.1001/jama.2024.28821","DOIUrl":"https://doi.org/10.1001/jama.2024.28821","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":""},"PeriodicalIF":63.1,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lawrence A Haber, David H Cloud, Chesa Boudin, Brie A Williams
{"title":"The Intersection of Climate Justice and Criminal Justice: Extreme Heat and Health Inequities in Carceral Facilities.","authors":"Lawrence A Haber, David H Cloud, Chesa Boudin, Brie A Williams","doi":"10.1001/jama.2024.27843","DOIUrl":"10.1001/jama.2024.27843","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"843-844"},"PeriodicalIF":63.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143016663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Statins for Primary Prevention of Cardiovascular Disease.","authors":"Maryanne Demasi, Rita F Redberg, John D Abramson","doi":"10.1001/jama.2024.26588","DOIUrl":"10.1001/jama.2024.26588","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"908-909"},"PeriodicalIF":63.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143400741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"US Ranks Highest in Global Overdose Deaths.","authors":"Samantha Anderer","doi":"10.1001/jama.2025.0240","DOIUrl":"10.1001/jama.2025.0240","url":null,"abstract":"","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"837"},"PeriodicalIF":63.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143366805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Israel S Maia, Letícia Kawano-Dourado, Lucas Tramujas, Neymar Elias de Oliveira, Rafael Naoki Souza, Dhaisi Faustino Signorini, Mariangela Pimentel Pincelli, Cássio Luis Zandonai, Regiane Tamires Blasius, Fabrício Freires, Vanessa Marques Ferreira, Marcelo Luz Pereira Romano, Mieko Claudia Miura, Caroline Maschio de Censo, Eliana Bernadete Caser, Betania Silva, Daniela Correia Santos Bonomo, Jussara Alencar Arraes, Meton Soares de Alencar Filho, Jacques Gabriel Álvares Horta, Déborah Campos Oliveira, Emerson Boschi, Rafael Lessa Costa, Glauco Adrieno Westphal, Juliano Ramos, Fábio Holanda Lacerda, Conrado Roberto Hoffmann Filho, Bruno Valle Pinheiro, Leonardo Bugarin de Andrade Neumamm, Mário Roberto Rezende Guimarães Júnior, Davi Tamamaru de Souza, Juliana Carvalho Ferreira, Louis Nakayama Ohe, Daniel Almeida Schettini, Marlus Muri Thompson, Maria Cristina França de Oliveira, Viviane Cordeiro Veiga, Karina L Negrelli, Renato H N Santos, Lucas Damiani, Rodrigo M Gurgel, Samara P C Gomes, Lucas M Lima, Tamiris A Miranda, Ligia N Laranjeira, Pedro Gabriel Melo de Barros E Silva, Flávia R Machado, Mark Fitzgerald, Anna Bosse, Joe Marion, Carlos Roberto Ribeiro Carvalho, Laurent Brochard, Roger J Lewis, Alexandre Biasi Cavalcanti
{"title":"High-Flow Nasal Oxygen vs Noninvasive Ventilation in Patients With Acute Respiratory Failure: The RENOVATE Randomized Clinical Trial.","authors":"Israel S Maia, Letícia Kawano-Dourado, Lucas Tramujas, Neymar Elias de Oliveira, Rafael Naoki Souza, Dhaisi Faustino Signorini, Mariangela Pimentel Pincelli, Cássio Luis Zandonai, Regiane Tamires Blasius, Fabrício Freires, Vanessa Marques Ferreira, Marcelo Luz Pereira Romano, Mieko Claudia Miura, Caroline Maschio de Censo, Eliana Bernadete Caser, Betania Silva, Daniela Correia Santos Bonomo, Jussara Alencar Arraes, Meton Soares de Alencar Filho, Jacques Gabriel Álvares Horta, Déborah Campos Oliveira, Emerson Boschi, Rafael Lessa Costa, Glauco Adrieno Westphal, Juliano Ramos, Fábio Holanda Lacerda, Conrado Roberto Hoffmann Filho, Bruno Valle Pinheiro, Leonardo Bugarin de Andrade Neumamm, Mário Roberto Rezende Guimarães Júnior, Davi Tamamaru de Souza, Juliana Carvalho Ferreira, Louis Nakayama Ohe, Daniel Almeida Schettini, Marlus Muri Thompson, Maria Cristina França de Oliveira, Viviane Cordeiro Veiga, Karina L Negrelli, Renato H N Santos, Lucas Damiani, Rodrigo M Gurgel, Samara P C Gomes, Lucas M Lima, Tamiris A Miranda, Ligia N Laranjeira, Pedro Gabriel Melo de Barros E Silva, Flávia R Machado, Mark Fitzgerald, Anna Bosse, Joe Marion, Carlos Roberto Ribeiro Carvalho, Laurent Brochard, Roger J Lewis, Alexandre Biasi Cavalcanti","doi":"10.1001/jama.2024.26244","DOIUrl":"10.1001/jama.2024.26244","url":null,"abstract":"<p><strong>Importance: </strong>High-flow nasal oxygen (HFNO) and noninvasive ventilation (NIV) are commonly used respiratory support therapies for patients with acute respiratory failure (ARF).</p><p><strong>Objective: </strong>To assess whether HFNO is noninferior to NIV on the rates of endotracheal intubation or death at 7 days in 5 patient groups with ARF.</p><p><strong>Design, setting, and participants: </strong>This noninferiority, randomized clinical trial enrolled hospitalized adults (aged ≥18 years; classified as 5 patient groups with ARF: nonimmunocompromised with hypoxemia, immunocompromised with hypoxemia, chronic obstructive pulmonary disease [COPD] exacerbation with respiratory acidosis, acute cardiogenic pulmonary edema [ACPE], or hypoxemic COVID-19, which was added as a separate group on June 26, 2023) at 33 hospitals in Brazil between November 2019 and November 2023 (final follow-up: April 26, 2024).</p><p><strong>Interventions: </strong>High-flow nasal oxygen (n = 883) or NIV (n = 883).</p><p><strong>Main outcomes and measures: </strong>The primary outcome was endotracheal intubation or death within 7 days assessed using a bayesian hierarchical model with dynamic borrowing across patient groups. Noninferiority was defined by a posterior probability of 0.992 or greater for an odds ratio (OR) less than 1.55.</p><p><strong>Results: </strong>Among 1800 patients, 1766 completed the study (mean age, 64 [SD, 17] years; 707 [40%] were women). The primary outcome of endotracheal intubation or death at 7 days occurred in 39% (344/883) in the HFNO group vs 38% (336/883) in the NIV group. In the immunocompromised with hypoxemia patient group, the primary outcome occurred in 57.1% (16/28) in the HFNO group vs 36.4% (8/22) in the NIV group; enrollment was stopped for futility (final OR, 1.07; 95% credible interval [CrI], 0.81-1.39; noninferiority posterior probability [NPP], 0.989). In the nonimmunocompromised with hypoxemia group, the primary outcome occurred in 32.5% (81/249) in the HFNO group vs 33.1% (78/236) in the NIV group (OR, 1.02 [95% CrI, 0.81-1.26]; NPP, 0.999). In the ACPE group, the primary outcome occurred in 10.3% (14/136) in the HFNO group vs 21.3% (29/136) in the NIV group (OR, 0.97 [95% CrI, 0.73-1.23]; NPP, 0.997). In the hypoxemic COVID-19 group, the primary outcome occurred in 51.3% (223/435) in the HFNO group vs 47.0% (210/447) in the NIV group (OR, 1.13 [95% CrI, 0.94-1.38]; NPP, 0.997). In the COPD exacerbation with respiratory acidosis group, the primary outcome occurred in 28.6% (10/35) in the HFNO group vs 26.2% (11/42) in the NIV group (OR, 1.05 [95% CrI, 0.79-1.36]; NPP, 0.992). However, a post hoc analysis without dynamic borrowing across the 5 ARF patient groups revealed some qualitatively different results in patients with COPD, immunocompromised patients, and patients with ACPE. The incidence of serious adverse events was similar (9.4% of patients in HFNO group vs 9.9% in NIV group).</p><p><strong>Conclusions","PeriodicalId":54909,"journal":{"name":"Jama-Journal of the American Medical Association","volume":" ","pages":"875-890"},"PeriodicalIF":63.1,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11897836/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142808637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}