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
HCor Research Institute, São Paulo, Brazil.
Hospital Moinhos de Vento, Porto Alegre, Brazil.
JAMA. 2017 Oct 10;318(14):1335-1345. doi: 10.1001/jama.2017.14171.
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.
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.
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.
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.
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.
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.
clinicaltrials.gov Identifier: NCT01374022.
肺复张手法和呼气末正压（PEEP）滴定对急性呼吸窘迫综合征（ARDS）患者临床结局的影响仍不确定。
确定与根据最佳呼吸系统顺应性进行PEEP滴定相关的肺复张与传统低PEEP策略相比，是否能降低中重度ARDS患者的28天死亡率。
设计、地点和参与者：2011年11月17日至2017年4月25日在9个国家的120个重症监护病房（ICU）进行的多中心随机试验，纳入中重度ARDS成人患者。
一种采用肺复张手法并根据最佳呼吸系统顺应性进行PEEP滴定的试验策略（n = 501；试验组）或低PEEP对照策略（n = 509）。所有患者在撤机前均接受容量辅助控制模式。
主要结局为28天内的全因死亡率。次要结局为ICU住院时间和住院时间；至第28天的无呼吸机天数；7天内需要引流的气胸；7天内的气压伤；以及ICU、住院和6个月死亡率。
共纳入1010例患者（女性占37.5%；平均[标准差]年龄为50.9[17.4]岁）并进行随访。在28天时，试验组501例患者中有277例（55.3%）死亡，对照组509例患者中有251例（49.3%）死亡（风险比[HR]，1.20；95%置信区间，1.01至1.42；P = 0.041）。与对照组相比，试验组策略增加了6个月死亡率（65.3%对59.9%；HR，1.18；95%置信区间，1.01至1.38；P = 0.04），减少了平均无呼吸机天数（5.3对6.4；差值，-1.1；95%置信区间，-2.1至-0.1；P = 0.03），增加了需要引流的气胸风险（3.2%对1.2%；差值，2.0%；95%置信区间，0.0%至4.0%；P = 0.03），以及气压伤风险（5.6%对1.6%；差值，4.0%；95%置信区间，1.5%至6.5%；P = 0.001）。在ICU住院时间、住院时间、ICU死亡率和住院死亡率方面无显著差异。
在中重度ARDS患者中，与低PEEP相比，采用肺复张和滴定PEEP的策略增加了28天全因死亡率。这些发现不支持在这些患者中常规使用肺复张手法和PEEP滴定。
clinicaltrials.gov标识符：NCT01374022。
