Saint Eloi University Hospital and Montpellier School of Medicine, Research Unit INSERM U1046, Montpellier, France.
Saint Antoine Hospital, AP-HP, Paris, France.
JAMA. 2016 Apr 5;315(13):1345-53. doi: 10.1001/jama.2016.2706.
It has not been established whether noninvasive ventilation (NIV) reduces the need for invasive mechanical ventilation in patients who develop hypoxemic acute respiratory failure after abdominal surgery.
To evaluate whether noninvasive ventilation improves outcomes among patients developing hypoxemic acute respiratory failure after abdominal surgery.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized, parallel-group clinical trial conducted between May 2013 and September 2014 in 20 French intensive care units among 293 patients who had undergone abdominal surgery and developed hypoxemic respiratory failure (partial oxygen pressure <60 mm Hg or oxygen saturation [SpO2] ≤90% when breathing room air or <80 mm Hg when breathing 15 L/min of oxygen, plus either [1] a respiratory rate above 30/min or [2] clinical signs suggestive of intense respiratory muscle work and/or labored breathing) if it occurred within 7 days after surgical procedure.
Patients were randomly assigned to receive standard oxygen therapy (up to 15 L/min to maintain SpO2 of 94% or higher) (n = 145) or NIV delivered via facial mask (inspiratory pressure support level, 5-15 cm H2O; positive end-expiratory pressure, 5-10 cm H2O; fraction of inspired oxygen titrated to maintain SpO2 ≥94%) (n = 148).
The primary outcome was tracheal reintubation for any cause within 7 days of randomization. Secondary outcomes were gas exchange, invasive ventilation-free days at day 30, health care-associated infections, and 90-day mortality.
Among the 293 patients (mean age, 63.4 [SD, 13.8] years; n=224 men) included in the intention-to-treat analysis, reintubation occurred in 49 of 148 (33.1%) in the NIV group and in 66 of 145 (45.5%) in the standard oxygen therapy group within+ 7 days after randomization (absolute difference, -12.4%; 95% CI, -23.5% to -1.3%; P = .03). Noninvasive ventilation was associated with significantly more invasive ventilation-free days compared with standard oxygen therapy (25.4 vs 23.2 days; absolute difference, -2.2 days; 95% CI, -0.1 to 4.6 days; P = .04), while fewer patients developed health care-associated infections (43/137 [31.4%] vs 63/128 [49.2%]; absolute difference, -17.8%; 95% CI, -30.2% to -5.4%; P = .003). At 90 days, 22 of 148 patients (14.9%) in the NIV group and 31 of 144 (21.5%) in the standard oxygen therapy group had died (absolute difference, -6.5%; 95% CI, -16.0% to 3.0%; P = .15). There were no significant differences in gas exchange.
Among patients with hypoxemic respiratory failure following abdominal surgery, use of NIV compared with standard oxygen therapy reduced the risk of tracheal reintubation within 7 days. These findings support use of NIV in this setting.
clinicaltrials.gov Identifier: NCT01971892.
非侵入性通气（NIV）是否可以减少腹部手术后发生低氧性急性呼吸衰竭的患者需要进行有创机械通气，目前尚未确定。
评估非侵入性通气是否可以改善腹部手术后发生低氧性急性呼吸衰竭的患者的结局。
设计、地点和参与者：这是一项多中心、随机、平行组临床试验，于 2013 年 5 月至 2014 年 9 月在法国 20 个重症监护病房进行，共纳入 293 例接受腹部手术且术后 7 天内发生低氧性呼吸衰竭（部分氧分压<60mmHg 或氧饱和度[SpO2]在呼吸空气时≤90%或呼吸 15L/min 氧气时<80mmHg，同时存在[1]呼吸频率高于 30/min 或[2]有明显的呼吸肌工作和/或呼吸困难的临床体征）的患者。
患者被随机分配接受标准氧疗（最高 15L/min 以维持 SpO2 高于 94%）（n=145）或经面罩给予 NIV（吸气压力支持水平 5-15cmH2O；呼气末正压 5-10cmH2O；吸入氧分数滴定以维持 SpO2≥94%）（n=148）。
主要结局是随机分组后 7 天内需要重新气管插管的原因。次要结局是第 30 天无有创通气天数、与医疗保健相关的感染和 90 天死亡率。
在 293 例（平均年龄 63.4[SD，13.8]岁；n=224 例男性）的意向治疗分析中，NIV 组有 49 例（33.1%）和标准氧疗组有 66 例（45.5%）在随机分组后+7 天内需要重新气管插管（绝对差值，-12.4%；95%CI，-23.5%至-1.3%；P=0.03）。与标准氧疗相比，NIV 显著增加了无有创通气天数（25.4 天比 23.2 天；绝对差值，-2.2 天；95%CI，-0.1 至 4.6 天；P=0.04），而与医疗保健相关的感染发生率较低（43/137[31.4%]比 63/128[49.2%]；绝对差值，-17.8%；95%CI，-30.2%至-5.4%；P=0.003）。90 天时，NIV 组有 22 例（14.9%）和标准氧疗组有 31 例（21.5%）患者死亡（绝对差值，-6.5%；95%CI，-16.0%至 3.0%；P=0.15）。两组在气体交换方面没有显著差异。
在腹部手术后发生低氧性呼吸衰竭的患者中，与标准氧疗相比，使用 NIV 可降低 7 天内需要重新气管插管的风险。这些发现支持在该环境中使用 NIV。
clinicaltrials.gov 标识符：NCT01971892。
