دورية أكاديمية
Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan.
| العنوان: | Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan. |
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| المؤلفون: | Maia IS; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.; Department of Anesthesiology, Pain, and Intensive Care, Universidade de São Paulo - São Paulo (SP), Brazil.; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil., Medrado FA Jr; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Tramujas L; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Tomazini BM; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil., Oliveira JS; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Sady ERR; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Barbante LG; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Nicola ML; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Gurgel RM; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Damiani LP; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Negrelli KL; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Miranda TA; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Santucci E; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Valeis N; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Laranjeira LN; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil., Westphal GA; Centro Hospitalar Unimed Joinville - Joinville (SC), Brazil., Fernandes RP; Centro Hospitalar Unimed Joinville - Joinville (SC), Brazil., Zandonai CL; Hospital Nereu Ramos - Florianópolis (SC), Brazil., Pincelli MP; Hospital Nereu Ramos - Florianópolis (SC), Brazil., Figueiredo RC; Hospital e Maternidade São José - Colatina (ES), Brazil.; Linhares Medical Center - Linhares (ES), Brazil., Bustamante CLS; Hospital e Maternidade São José - Colatina (ES), Brazil., Norbin LF; Linhares Medical Center - Linhares (ES), Brazil., Boschi E; Hospital Geral de Caxias do Sul - Caxias do Sul (RS), Brazil., Lessa R; Hospital Geral de Caxias do Sul - Caxias do Sul (RS), Brazil., Romano MP; Hcor-Hospital do Coração - São Paulo (SP), Brazil., Miura MC; Hcor-Hospital do Coração - São Paulo (SP), Brazil., Alencar Filho MS; Hospital São Vicente de Paulo - Barbalha (CE), Brazil., Dantas VCS; Hospital Marcílio Dias - Rio de Janeiro (RJ), Brazil., Barreto PA; Hospital Marcílio Dias - Rio de Janeiro (RJ), Brazil., Hernandes ME; Santa Casa de Votuporanga - Votuporanga (SP), Brazil., Grion CMC; Hospital Universitário, Universidade Estadual de Londrina - Londrina (PR), Brazil.; Hospital Araucária de Londrina - Londrina (PR), Brazil., Laranjeira AS; Hospital Universitário, Universidade Estadual de Londrina - Londrina (PR), Brazil., Mezzaroba AL; Hospital Araucária de Londrina - Londrina (PR), Brazil., Bahl M; Hospital Universitário, Universidade Federal de Santa Catarina - Florianópolis (SC), Brazil., Starke AC; Hospital Universitário, Universidade Federal de Santa Catarina - Florianópolis (SC), Brazil., Biondi RS; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.; Hospital Brasília - Brasília (DF), Brazil., Dal-Pizzol F; Hospital São José - Criciúma (SC), Brazil., Caser EB; Hospital Unimed Vitória - Vitória (SC), Brazil., Thompson MM; Hospital Evangélico de Cachoeiro de Itapemirim - Cachoeiro de Itapemirim (ES), Brazil., Padial AA; Instituto Baía Sul - Florianópolis (SC), Brazil., Veiga VC; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brazil., Leite RT; BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brazil., Araújo G; Imperial Hospital de Caridade - Florianópolis (SC), Brazil., Guimarães M; Santa Casa de Misericórdia de Barretos - Barretos (SP), Brazil., Martins PA; Hospital Estadual Dr. Jayme Santos Neves - Serra (ES), Brazil., Lacerda FH; Hospital Otoclínica - Fortaleza (CE), Brazil., Hoffmann Filho CR; Hospital Regional Hans Dieter Schmidt - Joinville (SC), Brazil., Melro L; Hospital Samaritano, São Paulo (SP), Brazil., Pacheco E; Hospital Sepaco - São Paulo (SP), Brazil., Ospina-Táscon GA; Fundación Valle del Lili - Universidad ICESI - Colombia, CO., Ferreira JC; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.; Department of Pneumology, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), Brazil., Freires FJC; Department of Anesthesiology, Pain, and Intensive Care, Universidade Federal de São Paulo - São Paulo (SP), Brazil., Machado FR; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.; Department of Anesthesiology, Pain, and Intensive Care, Universidade Federal de São Paulo - São Paulo (SP), Brazil., Cavalcanti AB; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.; Department of Anesthesiology, Pain, and Intensive Care, Universidade de São Paulo - São Paulo (SP), Brazil.; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil., Zampieri FG; Research Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.; Brazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.; Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta and Alberta Health Services - Edmonton, Alberta, Canada. |
| مؤلفون مشاركون: | STAMINA Study Group Investigators |
| المصدر: | Critical care science [Crit Care Sci] 2024 May 20; Vol. 36, pp. e20240210en. Date of Electronic Publication: 2024 May 20 (Print Publication: 2024). |
| نوع المنشور: | Clinical Trial Protocol; Journal Article |
| اللغة: | English; Portuguese |
| بيانات الدورية: | Publisher: Associação de Medicina Intensiva Brasileira Country of Publication: Brazil NLM ID: 9918627781706676 Publication Model: eCollection Cited Medium: Internet ISSN: 2965-2774 (Electronic) Linking ISSN: 29652774 NLM ISO Abbreviation: Crit Care Sci Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: São Paulo, SP, Brazil : Associação de Medicina Intensiva Brasileira, [2023]- |
| مواضيع طبية MeSH: | Community-Acquired Infections*/therapy , Positive-Pressure Respiration*/methods , Respiratory Distress Syndrome*/therapy , Respiratory Distress Syndrome*/physiopathology, Humans ; Brazil/epidemiology ; Colombia/epidemiology ; Intensive Care Units ; Pneumonia/therapy ; Prospective Studies ; Tidal Volume ; Randomized Controlled Trials as Topic ; Multicenter Studies as Topic |
| مستخلص: | Background: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. Objective: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. Methods: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. Outcomes: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. Conclusion: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial. |
| References: | Br J Anaesth. 2019 Jul;123(1):88-95. (PMID: 30961913) Respir Med. 2021 Oct;187:106555. (PMID: 34352563) N Engl J Med. 2000 May 4;342(18):1301-8. (PMID: 10793162) Ann Am Thorac Soc. 2020 May;17(5):557-558. (PMID: 32356695) JAMA. 2020 Oct 6;324(13):1307-1316. (PMID: 32876695) JAMA. 2008 Feb 13;299(6):646-55. (PMID: 18270353) Crit Care. 2016 Aug 22;20:276. (PMID: 27545828) Ann Am Thorac Soc. 2020 May;17(5):596-604. (PMID: 32069068) Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957) N Engl J Med. 2015 Feb 19;372(8):747-55. (PMID: 25693014) JAMA. 2008 Feb 13;299(6):637-45. (PMID: 18270352) N Engl J Med. 2015 Feb 19;372(8):776-7. (PMID: 25693019) Chest. 2022 Jun;161(6):1566-1575. (PMID: 35131298) J Clin Med. 2022 Jan 10;11(2):. (PMID: 35054013) Crit Care. 2016 Sep 09;20:268. (PMID: 27608629) N Engl J Med. 2004 Jul 22;351(4):327-36. (PMID: 15269312) Curr Opin Crit Care. 2020 Feb;26(1):53-58. (PMID: 31738234) Crit Care. 2017 Aug 4;21(1):199. (PMID: 28774316) Am J Respir Crit Care Med. 2020 Jun 1;201(11):1380-1388. (PMID: 32275452) JAMA. 2017 Oct 10;318(14):1335-1345. (PMID: 28973363) Lancet Respir Med. 2020 Mar;8(3):267-276. (PMID: 32043986) |
| تواريخ الأحداث: | Date Created: 20240522 Date Completed: 20240522 Latest Revision: 20240717 |
| رمز التحديث: | 20240718 |
| مُعرف محوري في PubMed: | PMC11098077 |
| DOI: | 10.62675/2965-2774.20240210-en |
| PMID: | 38775567 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2965-2774 |
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| DOI: | 10.62675/2965-2774.20240210-en |