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 - Critical Care Science (CCS)
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
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.
, Maia IS, Medrado Jr FA, Tramujas L, Tomazini BM, Oliveira JS, Sady ERR, et al. 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. Crit Care Sci 2024;36:e20240210en.
Electronic Document Format (ABNT)
, ; Maia, Israel Silva; Medrado Jr, Fernando Azevedo; Tramujas, Lucas; Tomazini, Bruno Martins; Oliveira, Júlia Souza; Sady, Erica Regina Ribeiro; Barbante, Letícia Galvão; Nicola, Marina Lazzari; Gurgel, Rodrigo Magalhães; Damiani, Lucas Petri; Negrelli, Karina Leal; Miranda, Tamiris Abait; Santucci, Eliana; Valeis, Nanci; Laranjeira, Ligia Nasi; Westphal, Glauco Adrieno; Fernandes, Ruthy Perotto; Zandonai, Cássio Luis; Pincelli, Mariangela Pimentel; Figueiredo, Rodrigo Cruvinel; Bustamante, Cíntia Loss Sartori; Norbin, Luiz Fernando; Boschi, Emerson; Lessa, Rafael; Romano, Marcelo Pereira; Miura, Mieko Cláudia; Alencar Filho, Meton Soares de; Dantas, Vicente Cés de Souza; Barreto, Priscilla Alves; Hernandes, Mauro Esteves; Grion, Cintia Magalhães Carvalho; Laranjeira, Alexandre Sanches; Mezzaroba, Ana Luiza; Bahl, Marina; Starke, Ana Carolina; Biondi, Rodrigo Santos; Dal-Pizzol, Felipe; Caser, Eliana Bernadete; Thompson, Marlus Muri; Padial, Andrea Allegrini; Veiga, Viviane Cordeiro; Leite, Rodrigo Thot; Araújo, Gustavo; Guimarães, Mário; Martins, Priscilla de Aquino; Lacerda, Fábio Holanda; Hoffmann Filho, Conrado Roberto; Melro, Livia; Pacheco, Eduardo; Ospina-Táscon, Gustavo Adolfo; Ferreira, Juliana Carvalho; Freires, Fabricio Jocundo Calado; Machado, Flávia Ribeiro; Cavalcanti, Alexandre Biasi; Zampieri, Fernando Godinho. 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. Crit Care Sci, v. 36, e20240210en, Apr. 2024.
Electronic Document Format (APA)
, , Maia, I. S., Medrado Jr, F. A., Tramujas, L., Tomazini, B. M., Oliveira, J. S., Sady, E. R. R., Barbante, L. G., Nicola, M. L., Gurgel, R. M., Damiani, L. P., Negrelli, K. L., Miranda, T. A., Santucci, E., Valeis, N., Laranjeira, L. N., Westphal, G. A., Fernandes, R. P., Zandonai, C. L., Pincelli, M. P., Figueiredo, R. C., Bustamante, C. L. S., Norbin, L. F., Boschi, E., Lessa, R., Romano, M. P., Miura, M. C., Alencar Filho, M. S. , Dantas, V. C. S., Barreto, P. A., Hernandes, M. E., Grion, C. M. C., Laranjeira, A. S., Mezzaroba, A. L., Bahl, M., Starke, A. C., Biondi, R. S., Dal-Pizzol, F., Caser, E. B., Thompson, M. M., Padial, A. A., Veiga, V. C., Leite, R. T., Araújo, G., Guimarães, M., Martins, P. A., Lacerda, F. H., Hoffmann Filho, C. R., Melro, L., Pacheco, E., Ospina-Táscon, G. A., Ferreira, J. C., Freires, F. J. C., Machado, F. R., Cavalcanti, A. B., & Zampieri, F. G. (2024). 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. Crit Care Sci, 36, e20240210en.
Electronic Document Format (ISO)
, and Maia, Israel Silva and Medrado Jr, Fernando Azevedo and Tramujas, Lucas and Tomazini, Bruno Martins and Oliveira, Júlia Souza and Sady, Erica Regina Ribeiro and Barbante, Letícia Galvão and Nicola, Marina Lazzari and Gurgel, Rodrigo Magalhães and Damiani, Lucas Petri and Negrelli, Karina Leal and Miranda, Tamiris Abait and Santucci, Eliana and Valeis, Nanci and Laranjeira, Ligia Nasi and Westphal, Glauco Adrieno and Fernandes, Ruthy Perotto and Zandonai, Cássio Luis and Pincelli, Mariangela Pimentel and Figueiredo, Rodrigo Cruvinel and Bustamante, Cíntia Loss Sartori and Norbin, Luiz Fernando and Boschi, Emerson and Lessa, Rafael and Romano, Marcelo Pereira and Miura, Mieko Cláudia and Alencar Filho, Meton Soares de and Dantas, Vicente Cés de Souza and Barreto, Priscilla Alves and Hernandes, Mauro Esteves and Grion, Cintia Magalhães Carvalho and Laranjeira, Alexandre Sanches and Mezzaroba, Ana Luiza and Bahl, Marina and Starke, Ana Carolina and Biondi, Rodrigo Santos and Dal-Pizzol, Felipe and Caser, Eliana Bernadete and Thompson, Marlus Muri and Padial, Andrea Allegrini and Veiga, Viviane Cordeiro and Leite, Rodrigo Thot and Araújo, Gustavo and Guimarães, Mário and Martins, Priscilla de Aquino and Lacerda, Fábio Holanda and Hoffmann Filho, Conrado Roberto and Melro, Livia and Pacheco, Eduardo and Ospina-Táscon, Gustavo Adolfo and Ferreira, Juliana Carvalho and Freires, Fabricio Jocundo Calado and Machado, Flávia Ribeiro and Cavalcanti, Alexandre Biasi and Zampieri, Fernando Godinho. 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. Crit Care Sci [online]. 2024, vol. 36, [cited 2024-05-19], e20240210en. Available from: <https://criticalcarescience.org/article/prospective-randomized-controlled-trial-assessing-the-effects-of-a-driving-pressure-limiting-strategy-for-patients-with-acute-respiratory-distress-syndrome-due-to-community-acquired-pneumoni/>.
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