近日，首都医科大学附属北京朝阳医院王辰教授团队，比较了高强度和低强度无创正压通气对慢性阻塞性肺疾病急性加重患者气管插管需求的影响。该项研究成果发表在2024年9月16日出版的《美国医学会杂志》上。

高强度无创正压通气（NPPV）对慢性阻塞性肺疾病（COPD）急性加重患者气管插管需求的影响尚不清楚。

为了确定高强度NPPV与低强度NPPV的使用相比是否减少了COPD急性加重和高碳酸血症患者气管插管的需求，2019年1月3日至2022年1月31日，研究组在中国医院的30个普通呼吸非重症监护病房进行了一项随机临床试验；最后一次90天随访是在2022年4月22日。纳入的患者在接受6小时的低强度NPPV治疗后，COPD急性加重，Paco₂水平大于45 mm Hg。

将患者以1:1的比例随机接受高强度NPPV，并调整吸气正压以获得预测体重的10 mL/kg至15 mL/kg的潮气量（n=147），或继续接受低强度NPPV和吸气正压，并调整至预测体重的6 mL/kg至10 mL/kg的潮气量（n=153）。低强度NPPV组中符合预先规定的气管插管需求标准的患者被允许交叉分组到高强度NPPV。主要结局是住院期间需要气管插管，是由预先指定的标准定义。有15个预先指定的次要结局，包括气管插管。

在对前300名患者进行中期分析后，数据和安全监测委员会和试验指导委员会终止了试验。在完成试验的300名患者中（平均年龄73岁[SD，10岁]；68%为男性），所有患者均纳入分析。在高强度NPPV组中，147名患者中有7名（4.8%）达到了气管插管需求的预设标准，而在低强度NPPV治疗组中，153名患者中有21名（13.7%）达到了这一主要结局（绝对差异为-9.0%[95%CI，-15.4%至-2.5%]，单侧P=0.004）。然而，两组之间的气管插管率没有显著差异（高强度NPPV组为3.4%[5/147]，低强度NPPV组为3.9%[6/153]；绝对差异为-0.5%[95%CI，-4.8%至3.7%]，P=0.81）。与低强度NPPV组（25.5%[39/153]）相比，高强度NPPV治疗组（37.4%[55/147]）的腹胀发生率更高。

研究结果表明，高强度NPPV组中患有慢性阻塞性肺病和持续高碳酸血症的患者（与低强度NPPV患者相比）满足气管插管需求标准的可能性明显降低；然而，低强度NPPV组的患者可交叉到高强度NPPV组，组间气管插管率没有显著差异。

附：英文原文

Title: Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: The HAPPEN Randomized Clinical Trial

Author: Zujin Luo, Yichong Li, Wenjun Li, Ying Li, Qingrong Nie, Yu Shi, Juan Wang, Qiuling Ji, Xuefeng Han, Sijie Liu, Dongmei Li, ShaSha Wang, Zhijun Li, Dong Jia, Huiqing Ge, Peifeng Xu, Zhijun Feng, Fengjie Li, Fucheng An, Na Tai, Lili Yue, Hongwei Xie, Xiuhong Jin, Hongru Liu, Qiang Dang, Yongxiang Zhang, Li Sun, Jinxiang Wang, He Huang, Liang Chen, Yingmin Ma, Zhixin Cao, Chen Wang, HAPPEN Investigators, Wenyao Fang, Dawei Zheng, Jingwen Wang, Xiaoguo Zhou, Xia Liu, Yanan Liu, Lina Liu, Congbin Yang, Zhenyang Xu, Ruiyan Lin, Jingjing Yang, Yan Peng, Jian Li, Chunxiao Yu, Xuemei Ling, Shan Ming, xinju Xu, Xiaohua Hou, Yongfa Zhang, Xiaohua Xue, Haiying Ma, Yun Shen, Xiuzhi Yang, Yongpeng An, Ting Mo, Xianyin Sang, Lidan Sun, Huaying Shi, Hua Zhang, Peng Zhang, Xiaoxia Chen, Lizhou Han, Yang Zhang, Zeng Wang, Yuping Guo, Yi Xiang, Jun Feng, Hua Qiao, Fei Chen, Xiaohong Yang

Issue&Volume: 2024-09-16

Abstract:

Importance  The effect of high-intensity noninvasive positive pressure ventilation (NPPV) on the need for endotracheal intubation in patients with an acute exacerbation of chronic obstructive pulmonary disease (COPD) is unknown.

Objective  To determine whether the use of high-intensity NPPV vs low-intensity NPPV reduces the need for endotracheal intubation in patients with an acute exacerbation of COPD and hypercapnia.

Design, Setting, and Participants  Randomized clinical trial conducted at 30 general respiratory non–intensive care unit wards of Chinese hospitals from January 3, 2019, to January 31, 2022; the last 90-day follow-up was on April 22, 2022. The included patients had an acute exacerbation of COPD and a Paco2 level greater than 45 mm Hg after receiving 6 hours of low-intensity NPPV.

Interventions  Patients were randomized 1:1 to receive high-intensity NPPV with inspiratory positive airway pressure that was adjusted to obtain a tidal volume 10 mL/kg to 15 mL/kg of predicted body weight (n=147) or to continue receiving low-intensity NPPV with inspiratory positive airway pressure that was adjusted to obtain a tidal volume of 6 mL/kg to 10 mL/kg of predicted body weight (n=153). Patients in the low-intensity NPPV group who met the prespecified criteria for the need for endotracheal intubation were allowed to crossover to high-intensity NPPV.

Main Outcomes and Measures  The primary outcome was the need for endotracheal intubation during hospitalization, which was defined by prespecified criteria. There were 15 prespecified secondary outcomes, including endotracheal intubation.

Results  The trial was terminated by the data and safety monitoring board and the trial steering committee after an interim analysis of the first 300 patients. Among the 300 patients who completed the trial (mean age, 73 years [SD, 10 years]; 68% were men), all were included in the analysis. The primary outcome of meeting prespecified criteria for the need for endotracheal intubation occurred in 7 of 147 patients (4.8%) in the high-intensity NPPV group vs 21 of 153 (13.7%) in the low-intensity NPPV group (absolute difference, 9.0% [95% CI, 15.4% to 2.5%], 1-sided P=.004). However, rates of endotracheal intubation did not significantly differ between groups (3.4% [5/147] in the high-intensity NPPV group vs 3.9% [6/153] in the low-intensity NPPV group; absolute difference, 0.5% [95% CI, 4.8% to 3.7%], P=.81). Abdominal distension occurred more frequently in the high-intensity NPPV group (37.4% [55/147]) compared with the low-intensity NPPV group (25.5% [39/153]).

Conclusions and Relevance  Patients with COPD and persistent hypercapnia in the high-intensity NPPV group (vs patients in the low-intensity NPPV group) were significantly less likely to meet criteria for the need for endotracheal intubation; however, patients in the low-intensity NPPV group were allowed to crossover to high-intensity NPPV, and the between-group rate of endotracheal intubation was not significantly different.

DOI: 10.1001/jama.2024.15815

Source: https://jamanetwork.com/journals/jama/fullarticle/2823763