Effect of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome secondary to community-acquired pneumonia: the STAMINA randomised clinical trial.

Livia Melro, Rafael Lessa, Marcelo Pereira Romano, Mieko Cláudia Miura, Priscilla Alves Barreto, Alexandre Sanches Laranjeira, Ana Luiza Mezzaroba, Marina Bahl, Marlus Muri Thompson, Andrea Allegrini Padial, Rodrigo Thot Leite, Gustavo Araújo, Mário Guimarães, Emerson Boschi, Eduardo Pacheco, Juliana Carvalho Ferreira, Bruno Tomazzini, Cassio Zandonai, Cíntia Loss Sartori Bustamante, Meton Soares de Alencar Filho, Vicente Cés de Souza Dantas, Eliana Caser, Priscilla Aquino, Fábio Lacerda, Gustavo Ospina-Táscon, Fabricio Jocundo Calado Freires, Mauro Esteves Hernandes, Conrado Roberto Hoffmann Filho, Glauco Adrieno Westphal, Cintia Grion, Rodrigo Biondi, Ligia Nasi Laranjeira, Israel Silva Maia, Flávia Ribeiro Machado, Lucas Petri Damiani, Alexandre Biasi Cavalcanti, Fernando Godinho Zampieri, Felipe Dal-Pizzol, Lucas Tramujas, Erica Regina Ribeiro Sady, Rodrigo Figueiredo, Ana Carolina Starke, Viviane Cordeiro Veiga, Júlia Souza Oliveira, Letícia Galvão Barbante, Marina Lazzari Nicola, Rodrigo Magalhães Gurgel, Karina Leal Negrelli, Tamiris Abait Miranda, Ruthy Perotto Fernandes, Mariangela Pimentel Pincelli, Luiz Fernando Norbin

Journal: British journal of anaesthesia 2025;134(3):693-702

PMID: 39592365

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Abstract

BACKGROUND

This study aimed to assess whether a driving pressure-limiting strategy based on positive end-expiratory pressure (PEEP) titration according to best respiratory system compliance and tidal volume adjustment increases the number of ventilator-free days within 28 days in patients with moderate to severe acute respiratory distress syndrome (ARDS).

METHODS

This is a multi-centre, randomised trial, enrolling adults with moderate to severe ARDS secondary to community-acquired pneumonia. Patients were randomised to a driving pressure-limiting strategy or low PEEP strategy based on a PEEP:FiO table. All patients received volume assist-control mode until day 3 or when considered ready for spontaneous modes of ventilation. The primary outcome was ventilator-free days within 28 days. Secondary outcomes were in-hospital and intensive care unit mortality at 90 days.

RESULTS

The trial was stopped because of recruitment fatigue after 214 patients were randomised. In total, 198 patients (n=96 intervention group, n=102 control group) were available for analysis (median age 63 yr, [interquartile range 47-73 yr]; 36% were women). The mean difference in driving pressure up to day 3 between the intervention and control groups was -0.7 cm HO (95% confidence interval -1.4 to -0.1 cm HO). Mean ventilator-free days were 6 (sd 9) in the driving pressure-limiting strategy group and 7 (9) in the control group (proportional odds ratio 0.72, 95% confidence interval 0.39-1.32; P=0.28). There were no significant differences regarding secondary outcomes.

CONCLUSIONS

In patients with moderate to severe ARDS secondary to community-acquired pneumonia, a driving pressure-limiting strategy did not increase the number of ventilator-free days compared with a standard low PEEP strategy within 28 days.

CLINICAL TRIAL REGISTRATION

NCT04972318.

Address: Instituto de Pesquisa Hcor, São Paulo, Brazil; Divisão de Anestesiologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; Hospital Nereu Ramos, Florianópolis, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.; Instituto de Pesquisa Hcor, São Paulo, Brazil; Divisão de Anestesiologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.; Instituto de Pesquisa Hcor, São Paulo, Brazil.; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.; Instituto de Pesquisa Hcor, São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil.; Hospital Nereu Ramos, Florianópolis, Brazil.; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Centro Hospitalar Unimed Joinville, Joinville, Brazil.; Centro Hospitalar Unimed Joinville, Joinville, Brazil.; Hospital e Maternidade São José, Colatina, Brazil; Linhares Medical Centre, Linhares, Brazil.; Hospital e Maternidade São José, Colatina, Brazil.; Linhares Medical Centre, Linhares, Brazil.; Hospital Geral de Caxias do Sul, Caxias do Sul, Brazil.; Hospital Hcor, São Paulo, Brazil.; Hospital São Vicente de Paulo, Barbalha, Brazil.; Hospital Marcílio Dias, Rio de Janeiro, Brazil.; Santa Casa de Votuporanga, Votuporanga, Brazil.; Hospital Universitário da Universidade Estadual de Londrina, Londrina, Brazil; Hospital Araucária de Londrina, Londrina, Brazil.; Hospital Universitário da Universidade Estadual de Londrina, Londrina, Brazil.; Hospital Araucária de Londrina, Londrina, Brazil.; Hospital Universitário da Universidade Federal de Santa Catarina, Florianópolis, Brazil.; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Hospital Brasília, Brasília, Brazil.; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Hospital São José, Criciúma, Brazil.; Hospital Unimed Vitória, Vitória, Brazil.; Hospital Evangélico de Cachoeiro de Itapemirim, Cachoeiro de Itapemirim, Brazil.; Hospital Baía Sul, Florianópolis, Brazil.; BP-A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.; Imperial Hospital de Caridade, Florianópolis, Brazil.; Santa Casa de Misericórdia de Barretos, Barretos, Brazil.; Hospital Estadual Dr. Jayme Santos Neves, Serra, Brazil.; Hospital Otoclínica, Fortaleza, Brazil.; Hospital Regional Hans Dieter Schmidt, Joinville, Brazil.; Hospital Samaritano, São Paulo, Brazil.; Hospital Sepaco, São Paulo, Brazil.; Fundación Valle del Lili-Universidad ICESI, Cali, Colombia.; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.; Departamento de Anestesiologia, Dor e Medicina Intensiva, Universidade Federal de São Paulo, São Paulo, Brazil.; Divisão de Anestesiologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Departamento de Anestesiologia, Dor e Medicina Intensiva, Universidade Federal de São Paulo, São Paulo, Brazil.; Instituto de Pesquisa Hcor, São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, and Alberta Health Service, Edmonton, AB, Canada. Electronic address: [email protected].

DOI: 10.1016/j.bja.2024.10.012

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MeSH Terms: Humans, Female, Middle Aged, Respiratory Distress Syndrome, Male, Community-Acquired Infections, Aged, Positive-Pressure Respiration, Pneumonia, Tidal Volume, Treatment Outcome, Hospital Mortality, Intensive Care Units, Community-Acquired Pneumonia