Please use this identifier to cite or link to this item: http://repositorio.unicamp.br/jspui/handle/REPOSIP/2081
Type: Artigo de periódico
Title: Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial
Author: Cavalcanti, Alexandre B.
Berwanger, Otavio
Suzumura, Erica A.
Amato, Marcelo B. P.
Tallo, Fernando S.
Rezende, Ederlon A. C.
Telles, Jose M. M.
Romano, Edson
Guimaraes, Helio P.
Regenga, Marisa M.
Takahashi, Luzia N.
Teixeira, Cassiano
Oliveira, Roselaine P.
Carvalho, Vitor O.
Diaz-Quijano, Fredi A.
Carvalho, Carlos R. R.
Cavalcanti, Alexandre B.
Suzumura, Erica A.
Berwanger, Otavio
Kodama, Alessandra A.
Ribeiro, Gisele F. M.
Abreu, Matheus O.
Oliveira, Ivonaldo M.
Guyatt, Gordon
Ferguson, Niall
Walter, Stephen
Vasconcelos, Marcia O. M.
Segundo, Valerio J.
Ferraz, Iris L.
Silva, Rosicley S.
de Oliveira Filho, Wilson
Silva, Nelson B.
Heirel, Debora C. B.
Takatani, Rodrigo R.
Sousa Neto, Jefferson A.
Neto, Jeronimo C. B.
Almeida, Samara D.
Chamy, Gauco
de Oliveira Filho, Wilson
Goncalves Neto, Graciliano J. L.
Almeida, Samara D.
Dias, Alysson P.
Silva, Rozangela R.
Tavares, Roberta C.
Souza, Marcia L. V. D.
Decio, Janaina C.
Lima, Cyntia M. L. S.
Ferreira Neto, Fleury
Oliveira, Katia R.
Dias, Polyana P. L. C.
Brandao, Andre L. S. B.
Ramos, Joroastro E., Jr.
Vasconcelos, Paula T.
Flores, Dimitri G.
Pinheiro Filho, Gilvan R.
Andrade, Isaac G.
Martinez, Amadeu
Franca, Gustavo G. P.
Monteiro, Livia L.
Correia, Emmanuel I. S.
Ribeiro, Wagner
Pereira, Antonio J.
Andrade, Wandalvo
Leite, Petronio A.
Pinheiro Filho, Gilvan R.
Flores, Dimitri G.
Filgueira Feto, Jose E.
Holanda, Marcelo A.
Amorim, Fabio F.
Margalho, Silviano B.
Domingues, Sergio M., Jr.
Ferreira, Claiton S.
Ferreira, Cassia M.
Rabelo, Livia A.
Duarte, Juliana N.
Lima, Fernando B.
Kawaguchi, Ines A. L.
Araujo Neto, Jose A.
Maia, Marcelo O.
Correa, Fabiano G.
Ribeiro, Rubens A. B.
Caser, Eliana
Moreira, Cora L. C. B.
Marcilino, Antonielen
Falcao, Jansen G.
Jesus, Karinne R.
Tcherniakovisk, Leo
Dutra, Victor G.
Thompson, Marlus M.
Piras, Claudio
Giuberti, Jonas, Jr.
Silva, Albano S.
Santos, Jose R. P.
Potratz, Jorge L.
Paula, Ludmila N.
Bozi, Giovana G.
Gomes, Bruno C.
Vassallo, Paula F.
Rocha, Edson P.
Lima, Maria H. B. S.
Ferreira, Denise M.
Goncalves, Fernanda A. F.
Pereira, Sheila A.
Nobrega, Marciano S.
Caixeta, Carlos R.
Moraes, Ana P. P.
Carvalho, Alexandre G. R.
Alves, Janine D.
Carvalho, Frederico B.
Moreira, Fabiana B. R.
Starling, Claudia M.
Couto, Wivian A. D.
Bitencourt, Wesley S.
Bitencourt, Wesley S.
Carvalho, Frederico B.
Peixoto, Daniela C.
Carvalho, Ivana L. V.
Silva, Silvangela G. A.
Felizardo, Livia R. S. M.
Magalhaes Nascimento, Francine J.
Santos, Priscila J. C. D.
Zanta, Camila C.
Martins, Marcele F.
Naves, Sergio A.
Silva, Fabiano D.
Laube, Gilberto, Jr.
Galvao, Endi L.
Sousa, Marcelo F.
Souza, Marcia M. F.
Carvalho, Fernanda L. G.
Bergo, Ricardo R.
Rezende, Claudnei M.
Tamazato, Edys Y.
Sarat, Saturnino Campo, Jr.
Almeida, Patricia S.
Gorski, Anthony G.
Matsui, Mirna
Eberhart Neto, Ervin
Nomoto, Silmara H.
Lima, Zildamara B.
Inagaki, Alexandre S.
Gil, Fernando S. U.
Araujo, Mario F. A.
Oliveira, Aline E.
Correa, Tiago A.
Mendonca, Angela
Reis, Helder
Carneiro, Saul R.
Castanelo, Carlos
Coelho, Edward, Jr.
Amaral, Karine A. E. H.
Rego, Leila R. M.
Cunha, Adenard F. C.
Barra, Williams F.
Carneiro, Mauricio
Batista, Roseane A.
Zoghbi, Karina K.
Machado, Nelma J. N.
Ferreira, Reinaldo
Apoena, Pablo
Leao, Rosangela M.
Martins, Eliauria R.
Oliveira, Marcelo E.
Odir, Isaura
Kleber, Wladimy
Tavares, Daniele
Martins, Eliauria R.
Araujo, Marcelo E. U.
Brilhante, Yuzeth Nobrega
Tavares, Daniele C. C.
Kleber, Wladmy
Carvalho, Waneska L. N.
Winveler, Georgia F. P.
Chagas Filho, Aldir
Cavalcanti, Raphael Ali
Grion, Cintia M. C.
Reis, Andrezza T. J. B.
Festti, Josiane
Gimenez, Francielli M. P.
Grion, Cintia M. C.
Larangeira, Alexandre S.
Cardoso, Lucienne T. Q.
Mezzaroba, Ana L.
Giancursi, Thiago S.
Kauss, Ivanil A. M.
Duarte, Pericles A. D.
Tozo, Tatiane C.
Peliser, Priscila
Germano, Almir
Gurgel, Sanderland J. T.
Silva, Sandra R. B.
Kuroda, Cristina M.
Herek, Andrea
Yamada, Sergio S.
Schiavetto, Paulo M.
Wysocki, Natacha
Matsubara, Rosely R.
Sales, Joao A. L., Jr.
Laprovita, Maria P.
Pena, Felipe M.
Sa, Alexandre
Vianna, Arthur
Verdeal, Juan C.
Martins, Gloria A.
Salgado, Diamantino R.
Coelho, Adalberto M.
Coelho, Milena P. P. M.
Morong, Aline S.
Poquiriqui, Rodolfo M. B.
Ferreira, Ana P.
Lucena, Debora N. L.
Marino, Nathalia F.
Moreira, Monique A.
Uratani, Cristiana C. S.
Severino, Marta A.
Silva, Patricia N.
Medeiros, Luciana G.
Chaves Filho, Francisco G.
Guimaraes, Daniela M. Q. S.
Rezende, Valeria M. C.
Carbonell, Roberto C. C.
Trindade, Renata S.
Pellegrini, Jose A. S.
Boniatti, Marcio M.
Santos, Moreno C.
Boldo, Rodrigo
Oliveira, Vanessa M.
Correa, Viviane M.
Nedel, Wagner
Teixeira, Cassiano
Oliveira, Roselaine P.
Schaich, Felipe
Tagliari, Luciana
Savi, Augusto
Schulz, Luis F.
Maccari, Juara G.
Oliveira, Roselaine P.
Teixeira, Cassiano
Seeger, Gabriela M.
Foernges, Rafael B.
Rieder, Marcelo M.
Becker, Daniel A.
Broilo, Fabiano P.
Schwarz, Patricia
Alencastro, Andre
Berto, Paula
Backes, Fabiane
Pellegrini, Jose A. S.
Dias, Fernando S.
Blattner, Clarissa
Martins, Edna T. J.
Scaglia, Nris C.
Vieira, Silvia R. R.
Prado, Karen F.
Fialkow, Lea
Franke, Cristiano
Vieira, Debora F. V. B.
Moraes, Rafael B.
Schwarz, Patricia
Marques, Leonardo S.
Hopf, Joao L. S.
Wawrzeniak, Iuri C.
Rech, Tatiana H.
Albuquerque, Regis B.
Guerreiro, Marcio O.
Teixeira, Luciano O.
Macedo, Pedro L.
Bainy, Marina P.
Ferreira, Edgard V.
Martins, Marcio A.
Andrade, Luciana A. S.
Machado, Fernando O.
Burigo, Ana C.
Pincelli, Mariangela
Kretzer, Lara
Maia, Israel S.
Cordeiro, Rodrigo B.
Westphal, Glauco
Caldeira, Milton
Cramer, Amanda S.
Dadam, Michelli M.
Barbosa, Pierry O.
Caldeira, Milton
Westphal, Glauco
Brilenger, Caroline O.
Horner, Marina B. W.
Oliveira, Glauce L.
Germiniani, Bruno C.
Teixeira, Cristina
Duarte, Robson
Assef, Maria G. P. L.
Rosso, Deorgelis
Bigolin, Rodrigo
Vanzuita, Raquel
Martins, Marcio A.
Prado, Luiz F. A.
Oliveira, Andre L. V.
Reis, Diego L.
Morais, Mirene O.
Bastos, Rafael S.
Santana, Hericalizandra S. R.
Silva, Alline O.
Cacau, Lucas A. P.
Almeida, Marilia S.
Canavessi, Hugo Schlebinger
Nogueira, Eduardo E. F.
Pavia, Caio L. P.
Reis, Diego L.
Araujo, Jose F.
Lira, Jose A.
Nienstedt, Esteban C.
Smith, Thiago C.
Romano, Edson
Romano, Marcelo
Regenga, Marisa M.
Barros, Dalton
Costa, Andre F.
Takahashi, Luzia
Werneck, Vinicius
Farran, Jorge
Henriques, Lilian A.
Miura, Claudia
Lopes, Renato D.
Vendrame, Leticia S.
Guimaraes, Helio P.
Sandri, Priscila
Galassi, Marcela S.
Carvalho, Carlos R. R.
Amato, Marcelo B. P.
Toufen, Carlos, Jr.
Santiago, Roberta R. S.
Hirota, Adriana S.
Park, Marcelo
Azevedo, Luciano C. P.
Malbouison, Luiz M.
Costa, Maristela C.
Taniguchi, Leandro
Pompilio, Carlos E.
Baruzzi, Claudio
Andrade, Ana H. V.
Taira, Elisabete E.
Taino, Bruno
Oliveira, Clezio S.
Silva, Anselmo C.
Isola, Alexandre
Rezende, Ederlon
Rodrigues, Ricardo G.
Rangel, Vivian P. L.
Luzzi, Sergio
Giacomassi, Ivens W. S.
Nassar, Antonio P., Jr.
Souza, Ana R.
Rahal, Luciana
Nunes, Andre L.
Giannini, Fabio
Menescal, Brena
Morais, Jussara E. P.
Toledo, Diogo
Morsch, Rafaela D.
Merluzzi, Thalita
Amorim, Denise S.
Bastos, Ana C. A. G.
Santos, Patricia L.
Silva, Sabrina F.
Gallego, Raquel C. N.
Santos, Gheisa D.
Tucci, Mauro
Costa, Ramon T.
Santos, Lucio S.
Demarzo, Sergio E.
Schettino, Guilherme P. P.
Azevedo, Luciano C. P.
Suzuki, Vivian C.
Patrocinio, Ana C. L.
Martins, Mariana L.
Passos, Denise B. V. G.
Cappi, Sylas B.
Goncalves, Iran, Jr.
Borges, Marcos C.
Lovato, Wilson
Tavares, Marcel V.
Morales, Daniela
Machado, Luis A. M. W.
Torres, Franciele C. C.
Gomes, Tania M.
Cerantola, Rodrigo B.
Gois, Aecio
Marraccini, Thiago
Margarida, Kathia
Cavalcante, Eulalia
Machado, Flavia R.
Mazza, Bruno F.
Rossetti Santana, Heloisa B.
Mendez, Vanessa M. F.
Xavier, Patricia A.
Rabelo, Melina V.
Schievano, Fabiana R.
Pinto, Walkyria A. M.
Francisco, Renata S.
Ferreira, Elaine M.
Silva, Dafne C. B.
Arduini, Rodrigo G.
Aldrighi, Jose R.
Amaro, Andreson F.
Conde, Katia A. P.
Pereira, Cesar A.
Tarkieltaub, Elcio
Oliver, Wilson R.
Guadalupe, Erika G. L.
Acerbi, Paulo S. C.
Tomizuka, Carlos I.
Oliveira, Tatiana A.
Geha, Nadia N.
Mecatti, Giovana C.
Piovesan, Maysa Z. R.
Salomao, Maria C.
Moreno, Marcelo S.
Orsatti, Vinicius N.
Miranda, Whiniton
Ray, Alexandre
Guerra, Andre
Baptista Filho, Mario L. A.
Ferreira, Firmino H., Jr.
Viera Filho, Edesio
Canzi, Regina A.
Giuberti, Adriana F. T.
Garcez, Melissa C. M.
Pedro, A.
Sala, Andrea D.
Suguitani, Edmundo O.
Kazue, Priscila
Oliveira, Luiz R. C.
Infantini, Rodrigo M.
Carvalho, Fabricio R. T.
Andrade, Lucia C.
Guimaraes, Helio P.
Santos, Thiago M.
Carmona, Cesar V.
Figueiredo, Luciana C.
Falcao, Antonio
Dragosavak, Desanka
Nogueira Filho, Wilson
Lunardi, Maria C.
Lago, Roberto
Gatti, Ciro
Chiasso, Tatiana M.
Santos, Grazielle O.
Silva, Aline C. F.
Araujo, Arthur C.
Ornellas, Izadora B.
Vieira, Vitor M.
Hajjar, Ludhmila A.
Figueiredo, Adelaide C.
Vieira, Vitor M.
Damasceno, Bruna
Pizarro, Camilo
Hinestrosa, Alfredo
Diaz-Quijano, Fredi A.
Garcia L., Sandra M. C.
Gonzalez C., Octavio
Diaz S., Edgard
Raineri, Santi M.
Cortegiani, Andrea
Abstract: Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.
Subject: Acute respiratory distress syndrome
Alveolar recruitment
PEEP
Mechanical ventilation
Clinical trials
Randomized
Editor: Biomed Central Ltd
Rights: fechado
Identifier DOI: 10.1186/1745-6215-13-153
Date Issue: 2012
Appears in Collections:FCM - Artigos e Materiais de Revistas Científicas

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