High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial.
High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial.
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DOI：
10.1186/s13054-020-03409-0
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发表时间：
2020-12-14
期刊：
影响因子：
--
通讯作者：
H. F.-AECOPD study investigators
中科院分区：
文献类型：
--
作者：
Cortegiani A;Longhini F;Madotto F;Groff P;Scala R;Crimi C;Carlucci A;Bruni A;Garofalo E;Raineri SM;Tonelli R;Comellini V;Lupia E;Vetrugno L;Clini E;Giarratano A;Nava S;Navalesi P;Gregoretti C;H. F.-AECOPD study investigators
高流量鼻治疗（HFNT）在慢性阻塞性肺疾病急性高碳酸血症加重（AECOPD）患者中的有效性和安全性尚不清楚。我们的目的是评估HFNT与NIV在轻中度AECOPD患者中的短期疗效，假设HFNT在治疗2小时后的CO2清除方面不劣于NIV。我们在意大利的9个中心进行了一项比较HFNT和无创通气（NIV）的多中心、非劣效性随机试验。如果患者出现轻度至中度AECOPD（呼吸机支持前动脉pH值7.25-7.35，PaCO 2 ≥ 55 mmHg），则患者合格。主要终点为符合方案分析中PaCO 2从基线至2 h的平均差异（非劣效性界值10 mmHg）。主要次要终点是在符合方案和意向治疗分析中HFNT在降低6 h PaCO 2方面非劣效于NIV以及治疗变化率。分析了79例患者（80例患者随机分组）。从基线到2小时，HFNT组PaCO 2降低的平均差异为− 6.8 mmHg（± 8.7），NIV组为− 9.5 mmHg（± 8.5）（p = 0.404）。6小时后，HFNT组32%的患者（13/40）转为NIV，1例转为有创通气。HFNT在统计学上非劣效于NIV，因为平均PaCO 2降低的绝对差异的95%置信区间（CI）上限未达到非劣效性界值10 mmHg（绝对差异2.7 mmHg;单侧95% CI 6.1; p = 0.0003）。两种治疗均对PaCO 2随时间的降低产生显著影响，组间趋势相似。在6 h符合方案分析和意向治疗分析中发现了相似的结果。HFNT在降低轻中度AECOPD患者治疗2小时后PaCO 2方面作为初始辅助支持在统计学上非劣效于NIV，考虑到非劣效性界值为10 mmHg。然而，32%接受HFNT的患者在6小时内需要NIV。采用优效性设计的进一步试验应评价HFNT在AECOPD中更强的患者相关结局和安全性的疗效。试验注册：本研究于2017年12月12日在ClinicalTrials.gov（NCT 03370666）上进行前瞻性注册。
The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).
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DOI：
10.1164/ajrccm.163.6.2002129
发表时间：
2001-05-01
影响因子：
24.7
作者：
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通讯作者：
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影响因子：
2.5
作者：
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作者：
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Navalesi, Paolo
DOI：
10.1164/rccm.201402-0364oc
发表时间：
2014-08-01
影响因子：
24.7
作者：
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通讯作者：
Antonelli, Massimo
影响因子：
6.9
作者：
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通讯作者：
Beasley, Richard