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
Authors: 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 
Published: April 2024

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.