Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA)
Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA)
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DOI：
10.1007/s00134-016-4594-y
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发表时间：
2016-12-01
影响因子：
38.9
通讯作者：
Jaber, Samir
中科院分区：
文献类型：
--
作者：
Futier, Emmanuel;Paugam-Burtz, Catherine;Jaber, Samir
高流量鼻插管（HFNC）氧疗作为标准氧疗的替代方案，在急性医学领域引起了越来越多的兴趣；然而，其用于预防腹部大手术后低氧血症的用途尚未得到评估。我们的试验旨在弥补这一证据差距。在法国三所大学医院进行了一项多中心随机对照试验。采用肺保护性通气进行腹部大手术的中度至高危术后肺部并发症的成年患者，采用计算机生成的序列随机分配，拔管后直接接受HFNC氧疗或标准氧疗（通过鼻尖或面罩输送低流量氧）。主要终点是拔管后1小时和停药后低氧血症的绝对风险降低（ARR）。次要结局包括术后7天内肺部并发症的发生、住院时间和院内死亡率。分析的数据来自修改后的意向治疗人群。该试验已在ClinicalTrials.gov注册（NCT01887015）。在2013年11月6日至2015年3月1日期间，220名患者被随机分配接受HFNC （n = 108）或标准氧疗（n = 112）；所有患者均完成随访。标准氧疗的中位持续时间为16小时（四分位数范围14-18小时），HFNC治疗的中位持续时间为15小时（四分位数范围12-18小时）。拔管后1 h用HFNC治疗的108例患者中有23例（21%）和108例停药后患者中有29例（27%）发生拔管后低氧血症，而112例用标准氧治疗的患者中分别有27例（24%）和34例（30%）（ARR 4, 95% CI -8 ~ 15%; p = 0.57；校正相对危险度[RR] 0.87, 95% CI 0.53 ~ 1.43; p = 0.58）。术后7天随访期间，两组患者无肺部并发症的比例差异无统计学意义（ARR 7, 95% CI -6 ~ 20%; p = 0.40）。其他次要结果在两组之间也没有显著差异。在接受腹部大手术的患者中，拔管后早期预防性应用高流量鼻插管氧疗与标准氧疗相比，并未导致肺预后的改善。
High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap.A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015).Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14-18 h) with standard oxygen therapy and 15 h (interquartile range 12-18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI -8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53-1.43; p = 0.58). Over the 7-day postoperative follow-up period, there was no statistically significant difference between the groups in the proportion of patients who remained free of any pulmonary complication (ARR 7, 95 % CI -6 to 20 %; p = 0.40). Other secondary outcomes also did not differ significantly between the two groups.Among patients undergoing major abdominal surgery, early preventive application of high-flow nasal cannula oxygen therapy after extubation did not result in improved pulmonary outcomes compared with standard oxygen therapy.