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
Authors: Luo Zujin , Li Yichong , Li Wenjun , Li Ying , Nie Qingrong , Shi Yu , Wang Juan , Ji Qiuling , Han Xuefeng , Liu Sijie , Li Dongmei , Wang ShaSha , Li Zhijun , Jia Dong , Ge Huiqing , Xu Peifeng , Feng Zhijun , Li Fengjie , An Fucheng , Tai Na , Yue Lili , Xie Hongwei , Jin Xiuhong , Liu Hongru , Dang Qiang , Zhang Yongxiang , Sun Li , Wang Jinxiang , Huang He , Chen Liang , Ma Yingmin , Cao Zhixin , Wang Chen ,   HAPPEN Investigators, Fang Wenyao , Zheng Dawei , Wang Jingwen , Zhou Xiaoguo , Liu Xia , Liu Yanan , Liu Lina , Yang Congbin , Xu Zhenyang , Lin Ruiyan , Yang Jingjing , Peng Yan , Li Jian , Yu Chunxiao , Ling Xuemei , Ming Shan , Xu xinju , Hou Xiaohua , Zhang Yongfa , Xue Xiaohua , Ma Haiying , Shen Yun , Yang Xiuzhi , An Yongpeng , Mo Ting , Sang Xianyin , Sun Lidan , Shi Huaying , Zhang Hua , Zhang Peng , Chen Xiaoxia , Han Lizhou , Zhang Yang , Wang Zeng , Guo Yuping , Xiang Yi , Feng Jun , Qiao Hua , Chen Fei , Yang Xiaohong , Wu Chao , Abula Abudusalamu , Tong Jin , Qin Yalan 
Published: September 2024

ImportanceThe 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.ObjectiveTo 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 ParticipantsRandomized 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.InterventionsPatients 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 MeasuresThe 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.ResultsThe 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 RelevancePatients 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.Trial RegistrationClinicalTrials.gov Identifier: NCT02985918