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

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; 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

Risultato della ricerca: Article

25 Citazioni (Scopus)

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
Lingua originaleEnglish
pagine (da-a)153-
Numero di pagine14
RivistaTrials
Volume13
Stato di pubblicazionePublished - 2012

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Adult Respiratory Distress Syndrome
Clinical Protocols
Randomized Controlled Trials
Length of Stay
Survival
Artificial Respiration
Ventilation
Ventilator-Induced Lung Injury
Barotrauma
Pressure
Chest Tubes
Tidal Volume
Pneumothorax
Hospital Mortality
Respiratory System
Compliance
Body Weight
Control Groups
Mortality

All Science Journal Classification (ASJC) codes

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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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; 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 (2012). Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial. Trials, 13, 153-.

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

In: Trials, Vol. 13, 2012, pag. 153-.

Risultato della ricerca: Article

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; 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 2012, 'Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial', Trials, vol. 13, pagg. 153-.
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; 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. Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial. Trials. 2012;13:153-.
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; 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. / Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial. In: Trials. 2012 ; Vol. 13. pagg. 153-.
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title = "Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial",
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",
keywords = "ARDS; Alveolar recruitment; PEEP",
author = "{Cavalcanti, Ab; Berwanger, O; Suzumura, {\'E}a; Amato, Mb; Tallo, Fs; Rezende, Ac; Telles, Mm; Romano, E; Guimar{\~a}es, Hp; Regenga, Mm; Takahashi, Ln; Oliveira, Rp; Carvalho, Vo; D{\'i}az-Quijano, Fa; Carvalho, Cr; Berwanger, O; Kodama, Aa; Ribeiro, Gf; Abreu, Mo; Oliveira, Im; Guyatt, G; Ferguson, N; Walter, S; Vasconcelos, Mo; Segundo, Vj; Ferraz, {\'I}l; Silva, Rs; De Oliveira Filho, W; Silva, Nb; Heirel, C; Takatani, Rr; Neto, Ja; Neto, Jc; Almeida, Sd} and Raineri, {Santi Maurizio} and Andrea Cortegiani",
year = "2012",
language = "English",
volume = "13",
pages = "153--",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",

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TY - JOUR

T1 - Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): study protocol for a randomized controlled trial

AU - 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; Berwanger, O; Koda

AU - Raineri, Santi Maurizio

AU - Cortegiani, Andrea

PY - 2012

Y1 - 2012

N2 - 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

AB - 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

KW - ARDS; Alveolar recruitment; PEEP

UR - http://hdl.handle.net/10447/73498

UR - http://www.trialsjournal.com/content/pdf/1745-6215-13-153.pdf

M3 - Article

VL - 13

SP - 153-

JO - Trials

JF - Trials

SN - 1745-6215

ER -