Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure–Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome,JAMA

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Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure–Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome
JAMA ( IF 63.1 ) Pub Date : 2019-03-05 , DOI: 10.1001/jama.2019.0555
Jeremy R Beitler ₁ , Todd Sarge ₂ , Valerie M Banner-Goodspeed ₂ , Michelle N Gong ₃ , Deborah Cook ₄ , Victor Novack ₅ , Stephen H Loring ₂ , Daniel Talmor ₂ ,

Affiliation

Importance Adjusting positive end-expiratory pressure (PEEP) to offset pleural pressure might attenuate lung injury and improve patient outcomes in acute respiratory distress syndrome (ARDS). Objective To determine whether PEEP titration guided by esophageal pressure (PES), an estimate of pleural pressure, was more effective than empirical high PEEP–fraction of inspired oxygen (FIO2) in moderate to severe ARDS. Design, Setting, and Participants 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. Interventions Participants were randomized to PES-guided PEEP (n = 102) or empirical high PEEP-FIO2 (n = 98). All participants received low tidal volumes. Main Outcomes and Measures 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. Results 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 PES-guided PEEP: 49.6% [95% CI, 41.7% to 57.5%]; P = .92). At 28 days, 33 of 102 patients (32.4%) assigned to PES-guided PEEP and 30 of 98 patients (30.6%) assigned to empirical PEEP-FIO2 died (risk difference, 1.7% [95% CI, −11.1% to 14.6%]; P = .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; P = .85). Patients assigned to PES-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%]; P = .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 PES-guided PEEP and 5 patients with empirical PEEP-FIO2. Conclusions and Relevance Among patients with moderate to severe ARDS, PES-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 PES-guided PEEP titration in ARDS. Trial Registration ClinicalTrials.gov Identifier NCT01681225

中文翻译：

采用食管压力引导策略滴定呼气末正压 (PEEP) 与经验性高 PEEP-Fio2 策略对急性呼吸窘迫综合征患者死亡和无机械通气天数的影响

重要性调整呼气末正压 (PEEP) 以抵消胸膜压可能会减轻肺损伤并改善急性呼吸窘迫综合征 (ARDS) 患者的预后。目的确定在中度至重度 ARDS 中，由食管压力 (PES) 指导的 PEEP 滴定是否比经验性高 PEEP - 吸入氧分数 (FIO2) 更有效。设计、设置和参与者在北美 14 家医院进行的 2 期随机临床试验。2012 年 10 月 31 日至 2017 年 9 月 14 日期间招募了 200 名 16 岁及以上的中度至重度 ARDS（PaO2:FIO2 ⩽200 mm Hg）机械通气患者；长期随访于2018年7月30日完成。干预参与者被随机分配到 PES 引导的 PEEP (n = 102) 或经验性高 PEEP-FIO2 (n = 98)。所有参与者都接受了低潮气量。主要结果和测量主要结果是一个综合评分，包括幸存者的死亡和第 28 天未使用机械通气的天数。预先设定的次要结果包括 28 天死亡率、幸存者中未使用机械通气的天数以及是否需要抢救治疗。结果 200 名患者入组（平均 [SD] 年龄，56 [16] 岁；46% 为女性）并完成了 28 天的随访。主要复合终点在治疗组之间没有显着差异（PES 指导的 PEEP 获得更有利结果的概率：49.6% [95% CI，41.7% 至 57.5%]；P = .92）。在 28 天时，102 名患者中有 33 名（32. 4%）分配给 PES 引导的 PEEP，分配给经验性 PEEP-FIO2 的 98 名患者中有 30 名（30.6%）死亡（风险差异，1.7% [95% CI，-11.1% 至 14.6%]；P = .88）。幸存者无机械通气的天数没有显着差异（中位数 [四分位距]：22 [15-24] 与 21 [16.5-24] 天；中位数差异，0 [95% CI，-1 至 2] 天；P = .85)。分配到 PES 引导的 PEEP 的患者接受抢救治疗的可能性显着降低（4/102 [3.9%] vs 12/98 [12.2%]；风险差异，-8.3% [95% CI，-15.8% 至 -0.8% ]；P = .04)。其他 7 个预先指定的次要临床终点均无显着差异。不良事件包括严重的气压伤，发生在 6 名 PES 引导的 PEEP 患者和 5 名经验性 PEEP-FIO2 患者中。结论和相关性在中度至重度 ARDS 患者中，与经验性高 PEEP-FIO2 相比，PES 引导的 PEEP 在死亡和无机械通气天数方面没有显着差异。这些发现不支持在 ARDS 中 PES 引导的 PEEP 滴定。试验注册 ClinicalTrials.gov 标识符 NCT01681225

更新日期：2019-03-05

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