Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.
Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.
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头盔与面罩无创通气对急性呼吸窘迫综合征患者气管插管率的影响：一项随机临床试验。
DOI：
10.1001/jama.2016.6338
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发表时间：
2016-06-14
期刊：
影响因子：
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通讯作者：
Kress JP
中科院分区：
文献类型：
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作者：
Patel BK;Wolfe KS;Pohlman AS;Hall JB;Kress JP
在预防急性呼吸窘迫综合征(ARDS)患者气管插管方面，戴面罩的无创呼吸机(NIV)相对无效。对于这些患者来说，戴着头盔进行NIV可能是一种更好的策略。目的：探讨头盔静脉输注是否能提高ARDS患者的气管插管率。对83名ARDS患者进行了单中心随机临床试验，这些患者需要在2012年10月3日至2015年9月21日期间在芝加哥大学的医疗重症监护病房通过面罩进行至少8小时的NIV。患者被随机分配到继续面罩NIV或切换到头盔进行NIV支持，计划登记206名患者(每组103名患者)。头盔是一个透明的头罩，覆盖着患者的整个头部，并有一个橡胶领颈部密封。早期试验终止导致44名患者随机进入头盔组，39名患者进入口罩组。主要结果是需要气管插管的患者的比例。次要结果包括28天无创呼吸机天数(即，没有机械通气的存活天数)、ICU持续时间和住院时间，以及住院天数和90天死亡率。83名患者(45%为女性；中位年龄59岁；中位急性生理学和慢性健康评估[APACHE]II评分，26分)在根据预先定义的疗效标准提前停止后进入分析。口罩组和头盔组的插管率分别为61.5%(n=24)和18.2%(n=8)(绝对差异，−为43.3%；95%CI，−为62.4%与−为24.3%；P<；.001)。戴头盔组的无呼吸机天数显著高于戴头盔组(28vs12.5，P<；.001)。90天后，头盔组有15名患者(34.1%)死亡，而面罩组有22名患者(56.4%)死亡(绝对差异，−为22.3%；95%CI，−为43.3%至−1.4%；P=0.02)。不良事件包括每组3个界面相关皮肤溃疡(即，面罩组有7.6%的人有鼻溃疡，头盔组有6.8%的人有颈部溃疡)。在ARDS患者中，使用头盔NIV治疗显著降低了插管率。头戴NIV头盔的90天死亡率在统计上也有显著降低。需要多中心研究来重复这些发现。ClinicalTrials.gov标识：NCT01680783
Noninvasive ventilation (NIV) with a face mask is relatively ineffective at preventing endotracheal intubation in patients with acute respiratory distress syndrome (ARDS). Delivery of NIV with a helmet may be a superior strategy for these patients. To determine whether NIV delivered by helmet improves intubation rate among patients with ARDS. Single-center randomized clinical trial of 83 patients with ARDS requiring NIV delivered by face mask for at least 8 hours while in the medical intensive care unit at the University of Chicago between October 3, 2012, through September 21, 2015. Patients were randomly assigned to continue face mask NIV or switch to a helmet for NIV support for a planned enrollment of 206 patients (103 patients per group). The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Early trial termination resulted in 44 patients randomized to the helmet group and 39 to the face mask group. The primary outcome was the proportion of patients who required endotracheal intubation. Secondary outcomes included 28-day invasive ventilator–free days (ie, days alive without mechanical ventilation), duration of ICU and hospital length of stay, and hospital and 90-day mortality. Eighty-three patients (45% women; median age, 59 years; median Acute Physiology and Chronic Health Evaluation [APACHE] II score, 26) were included in the analysis after the trial was stopped early based on predefined criteria for efficacy. The intubation rate was 61.5% (n = 24) for the face mask group and 18.2% (n = 8) for the helmet group (absolute difference, −43.3%; 95% CI, −62.4%to −24.3%; P < .001). The number of ventilator-free days was significantly higher in the helmet group (28 vs 12.5, P < .001). At 90 days, 15 patients (34.1%) in the helmet group died compared with 22 patients (56.4%) in the face mask group (absolute difference, −22.3%; 95% CI, −43.3 to −1.4; P = .02). Adverse events included 3 interface-related skin ulcers for each group (ie, 7.6% in the face mask group had nose ulcers and 6.8% in the helmet group had neck ulcers). Among patients with ARDS, treatment with helmet NIV resulted in a significant reduction of intubation rates. There was also a statistically significant reduction in 90-day mortality with helmet NIV. Multicenter studies are needed to replicate these findings. clinicaltrials.gov Identifier: NCT01680783