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Trials. 2012 Aug 28;13:153. doi: 10.1186/1745-6215-13-153.

Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial.

Collaborators (459)

Cavalcanti AB, Berwanger O, Suzumura ÉA, Amato MB, Tallo FS, Rezende AC, Telles MM, Romano E, Guimarães HP, Regenga MM, Takahashi LN, Oliveira RP, Carvalho VO, Díaz-Quijano FA, Carvalho CR, Cavalcanti AB, Berwanger O, Kodama AA, Ribeiro GF, Abreu MO, Oliveira IM, Guyatt G, Ferguson N, Walter S, Vasconcelos MO, Segundo VJ, Ferraz ÍL, Silva RS, de Oliveira Filho W, Silva NB, Heirel C, Takatani RR, Neto JA, Neto JC, Almeida SD, Chamy G, de Oliveira Filho W, Neto GJ, Almeida SD, Dias AP, Silva RR, Tavares RC, Souza ML, Decio JC, Lima CM, Neto FF, Oliveira KR, Dias PP, Brandão AL, Ramos JE Jr, Vasconcelos PT, Flôres DG, Filho GR, Andrade IG, Martinez A, França GG, Monteiro LL, Correia EI, Ribeiro W, Pereira AJ, Andrade W, Leite PA, Filho GR, Flôres DG, Feto JE, Holanda MA, Amorim FF, Margalho SB, Domingues SM Jr, Ferreira CS, Ferreira CM, Rabelo LA, Duarte JN, Lima FB, Kawaguchi IA, Neto JA, Maia MO, Correa FG, Ribeiro RA, Caser E, Moreira CL, Marcilino A, Falcão JG, Jesus KR, Tcherniakovisk L, Dutra VG, Thompson MM, Piras C, Giuberti J Jr, Silva AS, Santos JR, Potratz JL, Paula LN, Bozi GG, Gomes BC, Vassallo PF, Rocha E, Lima MH, Ferreira DM, A F, Gonçalves F, Pereira SA, Nobrega MS, Caixeta CR, Moraes AP, Carvalho AG, Alves JD, Carvalho FB, Moreira FB, Starling CM, Couto WA, Bitencourt WS, Carvalho FB, Peixoto DC, Carvalho IL, Silva SG, Felizardo LR, Nascimento FJ, C PJ, Santos D, Zanta CC, Martins MF, Naves SA, Silva FD, Laube G Jr, Galvão EL, Sousa MF, Souza MM, Carvalho FL, Bergo RR, Rezende CM, Tamazato EY, Sarat SC Jr, Almeida PS, Gorski AG, Matsui M, Neto EE, Nomoto SH, Lima ZB, Inagaki AS, Gil FS, Araújo MF, Oliveira AE, Correa TA, Mendonça A, Reis H, Carneiro SR, Rego LR, Cunha AF, Barra WF, Carneiro M, Batista RA, Zoghbi KK, Machado NJ, Ferreira R, Apoena P, Leão RM, Martins ER, Oliveira ME, Odir I, Kleber W, Tavares D, Martins ER, Araújo ME, Brilhante YN, Tavares DC, Kleber W, Carvalho WL, Winveler GF, Filho AC, Cavalcanti RA, Grion CM, Reis AT, Festti J, Gimenez FM, Grion CM, Larangeira AS, Cardoso LT, L AL, Mezzaroba TS, Kauss IA, Duarte PA, Tozo TC, Peliser P, Germano A, Gurgel SJ, Silva SR, Kuroda CM, Herek A, Yamada SS, Schiavetto PM, Wysocki N, Matsubara RR, Sales JA Jr, Laprovita MP, Pena FM, Sá A, Vianna A, Verdeal JC, Martins GA, Salgado DR, Coelho AM, P MP, Coelho M, Morong AS, Poquiriqui RM, Ferreira AP, Lucena DN, Marino NF, Moreira MA, Uratani CC, Severino MA, Silva PN, Medeiros LG, Filho FG, Guimarães DM, Rezende VM, Carbonell RC, Trindade RS, Pellegrini JA, Boniatti MM, Santos MC, Boldo R, Oliveira VM, Corrêa VM, Nedel W, Teixeira C, Oliveira RP, Schaich F, Tagliari L, Savi A, Schulz LF, Maccari JG, Oliveira RP, Teixeira C, Seeger GM, Foernges RB, Rieder MM, Becker DA, Broilo FP, Schwarz P, Alencastro A, Berto P, Backes F, Pellegrini JA, Dias FS, Blattner C, Martins ET, Scaglia NC, Vieira SR, Prado KF, Fialkow L, Franke C, Vieira DF, Moraes RB, Schwarz P, Marques LS, Hopf JL, Wawrzeniak IC, Rech TH, Albuquerque RB, Guerreiro MO, Teixeira LO, Macedo PL, Bainy MP, Ferreira EV, Martins MA, Andrade LA, Machado FO, Burigo AC, Pincelli M, Kretzer L, Maia IS, Cordeiro RB, Westphal G, Cramer AS, Dadam MM, Barbosa PO, Caldeira M, Westphal G, Brilenger CO, Horner MB, Oliveira GL, Germiniani BC, Teixeira C, Duarte R, Assef MG, Rosso D, Bigolin R, Vanzuita R, Martins MA, Prado LF, L A, Oliveira V, Reis DL, Morais MO, Bastos RS, Santana HS, Silva AO, Cacau LA, Almeida MS, Canavessi HS, Nogueira EE, Pavia CL, Reis DL, Araujo JF, Lira JA, Nienstedt EC, Smith TC, Romano E, Romano M, Regenga MM, Barros D, Costa AF, Takahashi L, Werneck V, Farran J, Henriques LA, Miura C, Lopes RD, Vendrame LS, Guimarães HP, Sandri P, Galassi MS, Carvalho CR, B M, Amato P, Toufen C Jr, Santiago RR, Hirota AS, Park M, Azevedo LC, Malbouison LM, Costa MC, Taniguchi L, Pompílio CE, Baruzzi C, Andrade AH, Taira EE, Taino B, Oliveira CS, Silva AC, Ísola A, Rezende E, Rodrigues RG, Rangel VP, Luzzi S, Giacomassi IW, Nassar AP Jr, Souza AR, Rahal L, Nunes AL, Giannini F, Menescal B, Morais JE, Toledo D, Morsch RD, Merluzzi T, Amorim DS, Bastos AC, Santos PL, Silva SF, Gallego RC, Santos GD, Tucci M, Costa RT, Santos LS, Demarzo SE, Schettino GP, Azevedo LC, Suzuki VC, Patrocinio AC, Martins ML, Passos DB, Cappi SB, Gonçalves I Jr, Borges MC, Lovato W, Tavares MV, Morales D, Machado LA, Torres FC, Gomes TM, Cerantola RB, Góis A, Marraccini T, Margarida K, Cavalcante E, Machado FR, Mazza BF, Santana HB, Mendez VM, Xavier PA, Rabelo MV, Schievano FR, Pinto WA, Francisco RS, Ferreira EM, Silva DC, Arduini RG, Aldrighi JR, Amaro AF, Conde KA, Pereira CA, Tarkieltaub E, Oliver WR, Guadalupe EG, Acerbi PS, Tomizuka CI, Oliveira TA, Geha NN, Mecatti GC, Piovesan MZ, Salomão MC, Moreno MS, Orsatti VN, Miranda W, Ray A, Guerra A, Filho ML, Ferreira FH Jr, Filho EV, Canzi RA, Giuberti AF, Garcez MC, Sala AD, Suguitani EO, Kazue P, Oliveira LR, Infantini RM, Carvalho FR, Andrade LC, Guimarães HP, Santos TM, Carmona CV, Figueiredo LC, Falcão A, Dragosavak D, Filho WN, Lunardi MC, Lago R, Gatti C, Chiasso TM, Santos GO, Silva AC, Araujo AC, Ornellas IB, Vieira VM, Hajjar LA, Figueiredo AC, Vieira VM, Damasceno B, Hinestrosa A, Diaz-Quijano FA, L SM, C OG, S ED, Raineri SM, Cortegiani A.

Author information

  • 1Research Institute - Hospital do Coração (IEP- HCor), Rua Abílio Soares 250, 12th floor, CEP: 04005-000, São Paulo, SP, Brazil. abiasi@hcor.com.br.

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 cmH2O 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.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT01374022.

PMID:
22929542
[PubMed - indexed for MEDLINE]
PMCID:
PMC3543273
Free PMC Article

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