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• W2912354430 abstract "<h3>Importance</h3> Adjusting positive end-expiratory pressure (PEEP) to offset pleural pressure might attenuate lung injury and improve patient outcomes in acute respiratory distress syndrome (ARDS). <h3>Objective</h3> To determine whether PEEP titration guided by esophageal pressure (P_ES), an estimate of pleural pressure, was more effective than empirical high PEEP–fraction of inspired oxygen (Fio₂) in moderate to severe ARDS. <h3>Design, Setting, and Participants</h3> Phase 2 randomized clinical trial conducted at 14 hospitals in North America. Two hundred mechanically ventilated patients aged 16 years and older with moderate to severe ARDS (Pao₂:Fio₂≤200 mm Hg) were enrolled between October 31, 2012, and September 14, 2017; long-term follow-up was completed July 30, 2018. <h3>Interventions</h3> Participants were randomized to P_ES-guided PEEP (n = 102) or empirical high PEEP-Fio₂(n = 98). All participants received low tidal volumes. <h3>Main Outcomes and Measures</h3> The primary outcome was a ranked composite score incorporating death and days free from mechanical ventilation among survivors through day 28. Prespecified secondary outcomes included 28-day mortality, days free from mechanical ventilation among survivors, and need for rescue therapy. <h3>Results</h3> Two hundred patients were enrolled (mean [SD] age, 56 [16] years; 46% female) and completed 28-day follow-up. The primary composite end point was not significantly different between treatment groups (probability of more favorable outcome with P_ES-guided PEEP: 49.6% [95% CI, 41.7% to 57.5%];<i>P</i> = .92). At 28 days, 33 of 102 patients (32.4%) assigned to P_ES-guided PEEP and 30 of 98 patients (30.6%) assigned to empirical PEEP-Fio₂died (risk difference, 1.7% [95% CI, −11.1% to 14.6%];<i>P</i> = .88). Days free from mechanical ventilation among survivors was not significantly different (median [interquartile range]: 22 [15-24] vs 21 [16.5-24] days; median difference, 0 [95% CI, −1 to 2] days;<i>P</i> = .85). Patients assigned to P_ES-guided PEEP were significantly less likely to receive rescue therapy (4/102 [3.9%] vs 12/98 [12.2%]; risk difference, −8.3% [95% CI, −15.8% to −0.8%];<i>P</i> = .04). None of the 7 other prespecified secondary clinical end points were significantly different. Adverse events included gross barotrauma, which occurred in 6 patients with P_ES-guided PEEP and 5 patients with empirical PEEP-Fio₂. <h3>Conclusions and Relevance</h3> Among patients with moderate to severe ARDS, P_ES-guided PEEP, compared with empirical high PEEP-Fio₂, resulted in no significant difference in death and days free from mechanical ventilation. These findings do not support P_ES-guided PEEP titration in ARDS. <h3>Trial Registration</h3> ClinicalTrials.gov IdentifierNCT01681225" @default.
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• W2912354430 date "2019-03-05" @default.
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• W2912354430 title "Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure–Guided Strategy vs an Empirical High PEEP-F<scp>io</scp>₂ Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome" @default.
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• W2912354430 doi "https://doi.org/10.1001/jama.2019.0555" @default.
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