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高流量鼻导管氧疗与无创通气在 COPD 患者拔管后应用的比较:一项多中心、随机对照试验。

High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial.

机构信息

Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.

Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.

出版信息

Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.

Abstract

BACKGROUND

High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure.

METHODS

COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa).

RESULTS

Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of - 50.0% (95% CI, - 74.6 to - 12.9%, p = 0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p < 0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p = 0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P < 0.001] and [0 vs 9.6%, p = 0.027], respectively.

CONCLUSION

Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV.

TRIAL REGISTRATION

chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.

摘要

背景

高流量鼻导管(HFNC)氧疗越来越多地用于预防拔管后低氧性呼吸衰竭和再插管。然而,支持 HFNC 用于拔管后合并高碳酸血症性呼吸衰竭的慢性阻塞性肺疾病(COPD)患者的证据有限。本研究旨在检验 HFNC 是否不劣于无创通气(NIV),以预防先前因高碳酸血症性呼吸衰竭而插管的 COPD 患者拔管后的治疗失败。

方法

在两家大型三级学术教学医院,对因高碳酸血症性呼吸衰竭而正在接受有创通气的 COPD 患者,在拔管时随机分配至 HFNC 或 NIV 治疗。主要终点是治疗失败,定义为再次开始有创通气或转换为另一种研究治疗方式(HFNC 组患者转换为 NIV,反之亦然)。

结果

96 例患者被随机分配至 HFNC 组或 NIV 组。在二次排除后,HFNC 组 44 例患者和 NIV 组 42 例患者纳入分析。HFNC 组的治疗失败率为 22.7%,NIV 组为 28.6%,风险差异为-5.8%(95%CI,-23.8 至 12.4%,p=0.535),显著低于 9%的非劣效性边界。对治疗失败原因的分析表明,HFNC 组的不耐受发生率明显低于 NIV 组,风险差异为-50.0%(95%CI,-74.6 至-12.9%,p=0.015)。拔管后 1 小时,两组的平均呼吸频率均高于拔管前的基础水平(p<0.050)。拔管后 24 小时,HFNC 组的呼吸频率已恢复至基础水平,但 NIV 组仍高于基础水平。拔管后 48 小时,两组的呼吸频率与基础水平相比均无显著差异。NIV 组每日气道护理干预的平均次数为 7(5-9.3)次,明显高于 HFNC 组的 6(4-7)次(p=0.006)。HFNC 组的舒适度评分和鼻面部皮肤破损发生率也明显优于 NIV 组[7(6-8)分 vs 5(4-7)分,P<0.001]和[0 比 9.6%,p=0.027]。

结论

在接受有创通气的 COPD 患者中,与 NIV 相比,拔管后使用 HFNC 并未导致治疗失败率增加。HFNC 的耐受性和舒适度也优于 NIV。

试验注册

chictr.org(ChiCTR1800018530)。于 2018 年 9 月 22 日注册,http://www.chictr.org.cn/usercenter.aspx。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b88/7412838/43745cd9355f/13054_2020_3214_Fig1_HTML.jpg

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