Evidence map›Paper›PMID 38775567›Full record

ArticleCritical care science2024

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.

STAMINA Study Group Investigators, Israel Silva Maia, Fernando Azevedo Medrado, Lucas Tramujas, Bruno Martins Tomazini, Júlia Souza Oliveira, Erica Regina Ribeiro Sady, Letícia Galvão Barbante, Marina Lazzari Nicola, Rodrigo Magalhães Gurgel and 46 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Critical care science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

56 authors.

STAMINA Study Group Investigators
Israel Silva MaiaResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-3467-5287
Fernando Azevedo MedradoResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-8049-9213
Lucas TramujasResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-6003-1314
Bruno Martins TomaziniResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6763-6132
Júlia Souza OliveiraResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Erica Regina Ribeiro SadyResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2390-1605
Letícia Galvão BarbanteResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Marina Lazzari NicolaResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-1711-2431
Rodrigo Magalhães GurgelResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Lucas Petri DamianiResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-5836-3379
Karina Leal NegrelliResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Tamiris Abait MirandaResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Eliana SantucciResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-1488-0857
Nanci ValeisResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-2209-0778
Ligia Nasi LaranjeiraResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.
Glauco Adrieno WestphalCentro Hospitalar Unimed Joinville - Joinville (SC), Brazil.ORCID http://orcid.org/0000-0001-9581-7141
Ruthy Perotto FernandesCentro Hospitalar Unimed Joinville - Joinville (SC), Brazil.
Cássio Luis ZandonaiHospital Nereu Ramos - Florianópolis (SC), Brazil.ORCID http://orcid.org/0009-0002-7855-1868
Mariangela Pimentel PincelliHospital Nereu Ramos - Florianópolis (SC), Brazil.ORCID http://orcid.org/0000-0002-7883-7965
Rodrigo Cruvinel FigueiredoHospital e Maternidade São José - Colatina (ES), Brazil.
Cíntia Loss Sartori BustamanteHospital e Maternidade São José - Colatina (ES), Brazil.
Luiz Fernando NorbinLinhares Medical Center - Linhares (ES), Brazil.
Emerson BoschiHospital Geral de Caxias do Sul - Caxias do Sul (RS), Brazil.ORCID http://orcid.org/0000-0002-0273-4759
Rafael LessaHospital Geral de Caxias do Sul - Caxias do Sul (RS), Brazil.
Marcelo Pereira RomanoHcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6773-1666
Mieko Cláudia MiuraHcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0009-0002-7806-3506
Meton Soares de Alencar FilhoHospital São Vicente de Paulo - Barbalha (CE), Brazil.ORCID http://orcid.org/0000-0001-6281-9917
Vicente Cés de Souza DantasHospital Marcílio Dias - Rio de Janeiro (RJ), Brazil.ORCID http://orcid.org/0000-0002-1865-1704
Priscilla Alves BarretoHospital Marcílio Dias - Rio de Janeiro (RJ), Brazil.
Mauro Esteves HernandesSanta Casa de Votuporanga - Votuporanga (SP), Brazil.ORCID http://orcid.org/0000-0002-5998-5364
Cintia Magalhães Carvalho GrionHospital Universitário, Universidade Estadual de Londrina - Londrina (PR), Brazil.ORCID http://orcid.org/0000-0001-9669-2010
Alexandre Sanches LaranjeiraHospital Universitário, Universidade Estadual de Londrina - Londrina (PR), Brazil.
Ana Luiza MezzarobaHospital Araucária de Londrina - Londrina (PR), Brazil.ORCID http://orcid.org/0000-0001-7318-8276
Marina BahlHospital Universitário, Universidade Federal de Santa Catarina - Florianópolis (SC), Brazil.ORCID http://orcid.org/0000-0003-1550-9638
Ana Carolina StarkeHospital Universitário, Universidade Federal de Santa Catarina - Florianópolis (SC), Brazil.ORCID http://orcid.org/0000-0002-7627-1929
Rodrigo Santos BiondiBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-9242-6062
Felipe Dal-PizzolHospital São José - Criciúma (SC), Brazil.ORCID http://orcid.org/0000-0003-3003-8977
Eliana Bernadete CaserHospital Unimed Vitória - Vitória (SC), Brazil.
Marlus Muri ThompsonHospital Evangélico de Cachoeiro de Itapemirim - Cachoeiro de Itapemirim (ES), Brazil.
Andrea Allegrini PadialInstituto Baía Sul - Florianópolis (SC), Brazil.
Viviane Cordeiro VeigaBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-0287-3601
Rodrigo Thot LeiteBP - A Beneficência Portuguesa de São Paulo - São Paulo (SP), Brazil.
Gustavo AraújoImperial Hospital de Caridade - Florianópolis (SC), Brazil.
Mário GuimarãesSanta Casa de Misericórdia de Barretos - Barretos (SP), Brazil.
Priscilla de Aquino MartinsHospital Estadual Dr. Jayme Santos Neves - Serra (ES), Brazil.ORCID http://orcid.org/0000-0003-2404-7455
Fábio Holanda LacerdaHospital Otoclínica - Fortaleza (CE), Brazil.ORCID http://orcid.org/0000-0001-6456-9413
Conrado Roberto Hoffmann FilhoHospital Regional Hans Dieter Schmidt - Joinville (SC), Brazil.ORCID http://orcid.org/0000-0001-8585-7940
Livia MelroHospital Samaritano, São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-8605-8745
Eduardo PachecoHospital Sepaco - São Paulo (SP), Brazil.
Gustavo Adolfo Ospina-TásconFundación Valle del Lili - Universidad ICESI - Colombia, CO.ORCID http://orcid.org/0000-0001-9370-3298
Juliana Carvalho FerreiraBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6548-1384
Fabricio Jocundo Calado FreiresDepartment of Anesthesiology, Pain, and Intensive Care, Universidade Federal de São Paulo - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-8473-7082
Flávia Ribeiro MachadoBrazilian Research in Intensive Care Network (BRICNet) - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-6921-227X
Alexandre Biasi CavalcantiResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0003-2798-6263
Fernando Godinho ZampieriResearch Institute, Hcor-Hospital do Coração - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0001-9315-6386

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDriving 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.

objectiveTo 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.

methodsThe 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.

conclusionSTAMINA 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.

Indexed as

Community-Acquired InfectionsPositive-Pressure RespirationRespiratory Distress SyndromeBrazilColombiaHumansIntensive Care UnitsMulticenter Studies as TopicPneumoniaProspective StudiesRandomized Controlled Trials as TopicTidal Volume

Identifiers

PMID38775567
PMCPMC11098077

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