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: 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, 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, Chao Wu, Abudusalamu Abula, Jin Tong, Yalan Qin
Journal: JAMA (2024)

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 Pa co 2 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. Trial Registration ClinicalTrials.gov Identifier: NCT02985918