Aims Non-invasive ventilation represents an established treatment for acute cardiogenic pulmonary oedema (ACPO) although no data regarding the best ventilatory strategy are available. We aimed to compare the effectiveness of helmet CPAP (hCPAP) and high flow nasal cannula (HFNC) in the early treatment of ACPO. Methods and results Single-centre randomized controlled trial of patients admitted to the emergency department due to ACPO with hypoxemia and dyspnoea on face mask oxygen therapy. Patients were randomly assigned with a 1:1 ratio to receive hCPAP or HFNC and FiO2 set to achieve an arterial oxygen saturation >94%. The primary outcome was a reduction in respiratory rate; secondary outcomes included changes in heart rate, PaO2/FiO2 ratio, Heart rate, Acidosis, Consciousness, Oxygenation, and Respiratory rate (HACOR) score, Dyspnoea Scale, and intubation rate. Data were collected before hCPAP/HFNC placement and after 1 h of treatment. Amongst 188 patients randomized, hCPAP was more effective than HFNC in reducing respiratory rate [−12 (95% CI; 11–13) vs. −9 (95% CI; 8–10), P < 0.001] and was associated with greater heart rate reduction [−20 (95% CI; 17–23) vs. −15 (95% CI; 12–18), P = 0.042], P/F ratio improvement [+149 (95% CI; 135–163) vs. +120 (95% CI; 107–132), P = 0.003] as well as in HACOR scores [6 (0–12) vs. 4 (2–9), P < 0.001] and Dyspnoea Scale [4 (1–7) vs. 3.5 (1–6), P = 0.003]. No differences in intubation rate were noted (P = 0.321). Conclusion Amongst patients with ACPO, hCPAP resulted in a greater short-term improvement in respiratory and hemodynamic parameters as compared with HFNC. Trial registration Clinical trial submission: NMRR-17-1839-36966 (IIR). Registry name: Medical Research and Ethics Committee of Malaysia Ministry of Health. Clinicaltrials.gov identifier: NCT04005092. URL registry: https://clinicaltrials.gov/ct2/show/NCT04005092.

中文翻译：

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头盔持续气道正压通气与高流量鼻导管吸氧治疗急性心源性肺水肿：一项随机对照试验

目的 无创通气代表了急性心源性肺水肿 (ACPO) 的既定治疗方法，尽管没有关于最佳通气策略的数据。我们旨在比较头盔式CPAP（hCPAP）和高流量鼻导管（HFNC）在ACPO早期治疗中的有效性。方法和结果 单中心随机对照试验，对因 ACPO 入院的急诊科患者进行面罩氧疗时低氧血症和呼吸困难的单中心随机对照试验。患者被随机分配以 1:1 的比例接受 hCPAP 或 HFNC 和 FiO2 设置以达到动脉血氧饱和度 > 94%。主要结果是呼吸频率降低；次要结局包括心率变化、PaO2/FiO2 比值、心率、酸中毒、意识、氧合和呼吸频率 (HACOR) 评分、呼吸困难量表、和插管率。在 hCPAP/HFNC 放置前和治疗 1 小时后收集数据。在随机分组的 188 名患者中，hCPAP 在降低呼吸频率方面比 HFNC 更有效 [-12 (95% CI; 11-13) 与 -9 (95% CI; 8-10)，P <; 0.001] 并与更大的心率降低相关 [-20 (95% CI; 17-23) vs. -15 (95% CI; 12-18), P = 0.042], P/F 比改善 [+149 ( 95% CI; 135–163) vs. +120 (95% CI; 107–132), P = 0.003] 以及 HACOR 评分 [6 (0–12) vs. 4 (2–9), P < ; 0.001] 和呼吸困难量表 [4 (1-7) vs. 3.5 (1-6), P = 0.003]。插管率没有差异（P = 0.321）。结论 在 ACPO 患者中，与 HFNC 相比，hCPAP 导致呼吸和血流动力学参数的短期改善更大。试验注册 临床试验提交：NMRR-17-1839-36966 (IIR)。注册名称：马来西亚卫生部医学研究和伦理委员会。Clinicaltrials.gov 标识符：NCT04005092。URL 注册：https://clinicaltrials.gov/ct2/show/NCT04005092。