CHU de Poitiers, Médecine Intensive Réanimation, Poitiers, France; équipe 5 ALIVE, INSERM, CIC-1402, Poitiers, France; Faculté de Médecine et de Pharmacie de Poitiers, Université de Poitiers, Poitiers, France.
Assistance Publique des Hôpitaux de Paris, Hôpital Louis Mourier, Service de Réanimation Médico-Chirurgicale, Colombes, France; Université Paris Diderot, UMR IAME 1137, Sorbonne Paris Cité, Paris, France.
Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.
Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation.
The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoing tracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO] to fraction of inspired oxygen [FiO] ratio of ≤300 mm Hg) were randomly assigned (1:1; block size, four participants) to non-invasive ventilation or high-flow oxygen during preoxygenation, with stratification by PaO/FiO ratio (≤200 mm Hg vs >200 mm Hg). Key exclusion criteria were intubation for cardiac arrest, altered consciousness (defined as a Glasgow coma score of less than eight points), other contraindications to non-invasive ventilation (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), pulse oximetry not available, pregnant or breastfeeding women, and refusal to participate. The primary outcome was the occurrence of severe hypoxaemia (pulse oximetry <80%) during the procedure, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02668458.
Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4·2%, 95% CI -13·7 to 5·5; p=0·39). In the 242 patients with moderate-to-severe hypoxaemia (PaO/FiO ≤200 mm Hg), severe hypoxaemia occurred less frequently after preoxygenation with non-invasive ventilation than with high-flow oxygen (28 [24%] of 117 patients vs 44 [35%] of 125; adjusted odds ratio 0·56, 0·32 to 0·99, p=0·0459). Serious adverse events did not differ between treatment groups, with the most common immediate complications being systolic arterial hypotension (70 [49%] patients in the non-invasive ventilation group vs 86 [50%] patients in the high-flow oxygen group) and chest infiltrate on x-ray (28 [20%] vs 33 [19%]), and the most common late complications being death at day 28 (53 [37%] vs 58 [34%]) and ventilator-associated pneumonia during ICU stay (31 [22%] vs 35 [20%]).
In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline.
French Ministry of Health.
从未比较过无创通气与高流量氧疗，以确定它们是否能降低气管插管期间严重低氧血症的风险。我们旨在确定预氧合时使用无创通气是否比高流量氧疗更能降低气管插管期间严重低氧血症的风险。
这项多中心、开放性 FLORALI-2 试验在法国 28 家重症监护病房进行。纳入急性低氧性呼吸衰竭（动脉血氧分压[PaO]与吸入氧分数[FiO]比值≤300mmHg）的患者，随机（1:1；分组大小为 4 人）接受预氧合时的无创通气或高流量氧疗，按 PaO/FiO 比值（≤200mmHg 与＞200mmHg）分层。主要排除标准为心搏骤停时的气管插管、意识改变（定义为格拉斯哥昏迷评分＜8 分）、其他无创通气禁忌证（最近的喉部、食管或胃部手术，以及严重面部骨折）、无脉搏血氧饱和度监测、妊娠或哺乳期妇女以及拒绝参与。主要结局为意向治疗人群中术中发生严重低氧血症（脉搏血氧饱和度＜80%）的情况。该试验在 ClinicalTrials.gov 上注册，编号为 NCT02668458。
2016 年 4 月 15 日至 2017 年 1 月 8 日，28 家参与单位共对 2079 名患者进行了气管插管，其中 322 名患者入组。我们排除了 5 名无记录数据的患者、2 名撤回同意或受法律保护的患者、1 名未进行气管插管的患者和 1 名发生心搏骤停的患者。在 313 名接受意向治疗分析的患者中，142 名患者被分配接受无创通气，171 名患者接受高流量氧疗。预氧合后，142 名患者中有 33 名（23%）发生严重低氧血症，171 名患者中有 47 名（27%）发生严重低氧血症（绝对差值-4.2%，95%CI-13.7 至 5.5；p=0.39）。在中重度低氧血症（PaO/FiO ≤200mmHg）的 242 名患者中，预氧合时使用无创通气后发生严重低氧血症的频率低于高流量氧疗（117 名患者中有 28 名[24%]，125 名患者中有 44 名[35%]；调整后的比值比 0.56，0.32 至 0.99，p=0.0459）。治疗组之间的严重不良事件没有差异，最常见的即刻并发症为收缩压降低（无创通气组 70 名[49%]患者，高流量氧疗组 86 名[50%]患者）和 X 线胸片显示胸部浸润（28 名[20%]患者，33 名[19%]患者），最常见的晚期并发症为 28 天病死率（53 名[37%]患者，58 名[34%]患者）和 ICU 期间呼吸机相关性肺炎（31 名[22%]患者，35 名[20%]患者）。
在急性低氧性呼吸衰竭患者中，预氧合时使用无创通气或高流量氧疗并不能改变严重低氧血症的风险。未来的研究应探讨中重度低氧血症患者的预氧合方法的效果。
法国卫生部。
