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October - 2017

   

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Effect of Lung Recruitment and Titrated Positive End-Expiratory Pressure (PEEP) vs Low PEEP on Mortality in Patients With Acute Respiratory Distress Syndrome

Writing Group for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) Investigators JAMA, 2017, Online first Sept 2017

Comment

This prospective RCT compares lung recruitment maneuver associated with positive end-expiratory pressure (PEEP) titration, according to the best respiratory-system compliance vs conventional low-PEEP strategy, on 28-day mortality, in patients with less than 72 hours of moderate to severe ARDS.

120 intensive care units (ICUs) from 9 countries enrolled 1010 patients over 5 1/2 years. The 2 ventilation strategies were;

  • Intervention: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory–system compliance (n = 501; experimental group)
  • Control strategy of low PEEP (n = 509). 
  • All patients received volume-assist control mode until weaning.

Analysis: It was an event-driven study designed to continue until 520 events (28-day deaths) had accrued. This number of events was estimated to provide 90% power, assuming a hazard ratio of 0.75 and type I error of 5%.

What they found

  • Baseline: 2 days since ventilation initiated, 15 hrs since ARDS onset, only 10% proned, P:F 118, Vt 5.8 ml/kg, Pplat 25cmH2O, driving pressure 13.5, PEEP 12 cm H2O
  • Treatment: 95.8% in the experimental group received a lung recruitment maneuver after randomization. In 15.6% of cases the maneuver was interrupted, most often due to hypotension or a decrease in oxygen saturation. The mean (SD) titrated PEEP was 16.8 (3.8) cm H2O. Lung recruitment was repeated after PEEP titration in 393 patients (78.4%). After the initial recruitment and PEEP titration, alveolar recruitment was not repeated from day 1 to 7 in most patients (62.7%)
  • Mean PEEP values were higher in the experimental than in the control group
  • Mean plateau pressure were higher in the experimental group, although always below 30 cm H2O in both groups. 
  • Mean tidal volumes were below 6 mL/kg of predicted body weight in both groups from hour 1 through day 3. 
  • Mean PaO2:FIO2 ratios were higher in the experimental group. 
  • Use of neuromuscular blockers was higher in the experimental than the control group (96.8% vs 73.3%; difference, 23.5%; 95% CI, 19.2%-27.9%; P < .001), reflecting the protocol requirement for their use before the recruitment maneuver
  • There were no differences among groups in other cointerventions or on the need of rescue therapies
  • Primary outcome: 28-d all-cause mortality was significantly higher in intervention group (55.3%) vs a conventional (49.3%)( HR 1.20, 95% CI, 1.01-1.42; P = .04) .
  • 6-month all-cause mortality was higher in the experimental than in the control group (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01-1.38; P = .04)
  • Secondary outcomes: there was a significant increase in pneumothorax and barotrauma in the experimental group.

A strategy using a lung recruitment maneuver and titrated PEEP, in association with volume-assist control ventilation, increased mortality of patients with moderate to severe ARDS


 

Abstract

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 Atotalof1010patients(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.

October


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