TY - JOUR
T1 - Effect of lung recruitment and titrated Positive End-Expiratory Pressure (PEEP) vs low PEEP on mortality in patients with acute respiratory distress syndrome - A randomized clinical trial
AU - Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators
AU - Cavalcanti, Alexandre Biasi
AU - Suzumura, Érica Aranha
AU - Laranjeira, Ligia Nasi
AU - De Moraes Paisani, Denise
AU - Damiani, Lucas Petri
AU - Guimarães, Helio Penna
AU - Romano, Edson Renato
AU - De Moraes Regenga, Marisa
AU - Taniguchi, Luzia Noriko Takahashi
AU - Teixeira, Cassiano
AU - De Oliveira, Roselaine Pinheiro
AU - Machado, Flavia Ribeiro
AU - Diaz-Quijano, Fredi Alexander
AU - De Alencar Filho, Meton Soares
AU - Maia, Israel Silva
AU - Caser, Eliana Bernardete
AU - De Oliveira Filho, Wilson
AU - De Carvalho Borges, Marcos
AU - De Aquino Martins, Priscilla
AU - Matsui, Mirna
AU - Ospina-Tascón, Gustavo Adolfo
AU - Giancursi, Thiago Simões
AU - Giraldo-Ramirez, Nelson Dario
AU - Vieira, Silvia Regina Rios
AU - De Lima Assef, Maria da Graça Pasquotto
AU - Hasan, Mohd Shahnaz
AU - Szczeklik, Wojciech
AU - Rios, Fernando
AU - Amato, Marcelo Britto Passos
AU - Berwanger, Otávio
AU - De Carvalho, Carlos Roberto Ribeiro
AU - Tucci, M. R.
AU - Souza Dos Santos, L.
AU - França de Oliveira, M. C.
AU - Peres, I.
AU - Freitas, I.
AU - Reis, H.
AU - Veríssimo, A.
AU - Torres, D.
AU - Barroso, A.
AU - Semboloni Bitencourt, W.
AU - Franco, M. R.
AU - Oliveira Lage, J.
AU - Aparecida Pessoa Conde, K.
AU - Charro, F. A.
AU - Naia, A.
AU - de Brito Sobrinho, E.
AU - Lameira Veríssimo, A.
AU - Barros de Oliveira, M. E.
AU - Zampieri, F.
N1 - Funding Information:
completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. All authors received grant support from Program to Support Institutional Development of Universal System (PROADI) from the Brazilian Ministry of Health to conduct the study. Dr Amato also received grants from Timpel S. A. and Medtronic. No other disclosures are reported.
Funding Information:
Funding/Support: This study was funded by and conducted as part of the Program to Support Institutional Development of Universal System (PROADI) from the Brazilian Ministry of Health. The trial was coordinated by the HCor Research Institute and endorsed by the Brazilian Research in Intensive Care Network (BRICNet).
Publisher Copyright:
© 2017 American Medical Association. All rights reserved.
PY - 2017/10/10
Y1 - 2017/10/10
N2 - IMPORTANCE: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain. OBJECTIVE: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS. INTERVENTIONS: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality. RESULTS: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, −1.1; 95% CI, −2.1 to −0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality. CONCLUSIONS AND RELEVANCE: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01374022.
AB - IMPORTANCE: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain. OBJECTIVE: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS. INTERVENTIONS: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning. MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality. RESULTS: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, −1.1; 95% CI, −2.1 to −0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality. CONCLUSIONS AND RELEVANCE: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01374022.
UR - http://www.scopus.com/inward/record.url?scp=85031327535&partnerID=8YFLogxK
U2 - 10.1001/jama.2017.14171
DO - 10.1001/jama.2017.14171
M3 - Article
C2 - 28973363
AN - SCOPUS:85031327535
SN - 0098-7484
VL - 318
SP - 1335
EP - 1345
JO - JAMA - Journal of the American Medical Association
JF - JAMA - Journal of the American Medical Association
IS - 14
ER -