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.
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Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators, Cavalcanti Alexandre Biasi, Suzumura Érica Aranha, Laranjeira Ligia Nasi, Paisani Denise de Moraes, Damiani Lucas Petri, Guimarães Helio Penna, Romano Edson Renato, Regenga Marisa de Moraes, Taniguchi Luzia Noriko Takahashi, Teixeira Cassiano, Pinheiro de Oliveira Roselaine, Machado Flavia Ribeiro, Diaz-Quijano Fredi Alexander, Filho Meton Soares de Alencar, Maia Israel Silva, Caser Eliana Bernardete, Filho Wilson de Oliveira, Borges Marcos de Carvalho, Martins Priscilla de Aquino, Matsui Mirna, Ospina-Tascón Gustavo Adolfo, Giancursi Thiago Simões, Giraldo-Ramirez Nelson Dario, Vieira Silvia Regina Rios, Assef Maria da Graça Pasquotto de Lima, Hasan Mohd Shahnaz, Szczeklik Wojciech, Rios Fernando, Amato Marcelo Britto Passos, Berwanger Otávio, Ribeiro de Carvalho Carlos Roberto
Аннотация
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.