Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure A Randomized Clinical Trial
Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure A Randomized Clinical Trial
复制标题
无创通气与氧气疗法对急性呼吸衰竭免疫受损患者死亡率的影响 一项随机临床试验
DOI：
10.1001/jama.2015.12402
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发表时间：
2015-10-27
影响因子：
120.7
通讯作者：
Azoulay, Elie
中科院分区：
文献类型：
--
作者：
Lemiale, Virginie;Mokart, Djamel;Azoulay, Elie
重要性无创通气已被推荐用于降低低氧血症急性呼吸衰竭免疫功能低下患者的死亡率。然而，它对这种适应症的有效性尚不清楚。目的探讨早期无创通气是否能改善免疫功能低下合并非高碳酸血症急性低氧性呼吸衰竭患者的生存率。设计、环境和参与者：2013年8月12日至2015年1月2日，在法国和比利时的28个重症监护病房（icu）对374名危重免疫功能低下患者进行了多中心随机试验，其中317名（84.7%）正在接受血液系统恶性肿瘤或实体肿瘤治疗。干预措施患者被随机分配到早期无创通气组（n = 191）或单纯氧疗组（n = 183）。主要结局和测量主要结局为第28天死亡率。次要结果为插管、第3天序贯器官衰竭评估评分、ICU获得性感染、机械通气持续时间和ICU住院时间。结果随机分组时，无创通气组中位氧流量为9 L/min（四分位数范围5-15），氧气组中位氧流量为9 L/min（四分位数范围6-15）。无创通气组的所有患者在随机分组后立即接受第一次无创通气。在随机分组后的第28天，无创通气组有46例（24.1%）死亡，而氧气组有50例（27.3%）死亡（绝对差异为-3.2 [95% CI, -12.1至5.6];P = 0.47）。无创通气组有73例（38.2%），氧气组有82例（44.8%）（绝对差异为-6.6 [95% CI, -16.6 ~ 3.4]; P = 0.20）。ICU获得性感染、机械通气持续时间、ICU或住院时间没有显著差异。在因低氧性急性呼吸衰竭而入住ICU的免疫功能低下患者中，早期无创通气与单纯氧疗相比并没有降低28天死亡率。然而，研究能力是有限的。
IMPORTANCE Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure. However, its effectiveness for this indication remains unclear.OBJECTIVE To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure.DESIGN, SETTING, AND PARTICIPANTS Multicenter randomized trial conducted among 374 critically ill immunocompromised patients, of whom 317 (84.7%) were receiving treatment for hematologic malignancies or solid tumors, at 28 intensive care units (ICUs) in France and Belgium between August 12, 2013, and January 2, 2015.INTERVENTIONS Patients were randomly assigned to early noninvasive ventilation (n = 191) or oxygen therapy alone (n = 183).MAIN OUTCOMES AND MEASURES The primary outcome was day-28 mortality. Secondary outcomes were intubation, Sequential Organ Failure Assessment score on day 3, ICU-acquired infections, duration of mechanical ventilation, and ICU length of stay.RESULTS At randomization, median oxygen flow was 9 L/min (interquartile range, 5-15) in the noninvasive ventilation group and 9 L/min (interquartile range, 6-15) in the oxygen group. All patients in the noninvasive ventilation group received the first noninvasive ventilation session immediately after randomization. On day 28 after randomization, 46 deaths (24.1%) had occurred in the noninvasive ventilation group vs 50 (27.3%) in the oxygen group (absolute difference, -3.2 [95% CI, -12.1 to 5.6]; P = .47). Oxygenation failure occurred in 155 patients overall (41.4%), 73 (38.2%) in the noninvasive ventilation group and 82 (44.8%) in the oxygen group (absolute difference, -6.6 [95% CI, -16.6 to 3.4]; P = .20). There were no significant differences in ICU-acquired infections, duration of mechanical ventilation, or lengths of ICU or hospital stays.CONCLUSIONS AND RELEVANCE Among immunocompromised patients admitted to the ICU with hypoxemic acute respiratory failure, early noninvasive ventilation compared with oxygen therapy alone did not reduce 28-day mortality. However, study power was limited.