1. 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.
- Author
-
Maia IS, Medrado FA Jr, Tramujas L, Tomazini BM, Oliveira JS, Sady ERR, Barbante LG, Nicola ML, Gurgel RM, Damiani LP, Negrelli KL, Miranda TA, Santucci E, Valeis N, Laranjeira LN, Westphal GA, Fernandes RP, Zandonai CL, Pincelli MP, Figueiredo RC, Bustamante CLS, Norbin LF, Boschi E, Lessa R, Romano MP, Miura MC, Alencar Filho MS, Dantas VCS, Barreto PA, Hernandes ME, Grion CMC, Laranjeira AS, Mezzaroba AL, Bahl M, Starke AC, Biondi RS, Dal-Pizzol F, Caser EB, Thompson MM, Padial AA, Veiga VC, Leite RT, Araújo G, Guimarães M, Martins PA, Lacerda FH, Hoffmann Filho CR, Melro L, Pacheco E, Ospina-Táscon GA, Ferreira JC, Freires FJC, Machado FR, Cavalcanti AB, and Zampieri FG
- Subjects
- Humans, Brazil epidemiology, Colombia epidemiology, Intensive Care Units, Pneumonia therapy, Prospective Studies, Tidal Volume, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Community-Acquired Infections therapy, Positive-Pressure Respiration methods, Respiratory Distress Syndrome therapy, Respiratory Distress Syndrome physiopathology
- Abstract
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.
- Published
- 2024
- Full Text
- View/download PDF