Internet of things-based management versus standard management of home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: a multicentre randomized controlled non-inferiority trial

被引:5
作者
Jiang, Weipeng [1 ]
Jin, Xiaoyan [2 ]
Du, Chunling [3 ]
Gu, Wenchao [4 ]
Gao, Xiwen [5 ]
Zhou, Chenjun [6 ]
Tu, Chunlin [7 ]
Chen, Hongqun [8 ]
Li, Hong [9 ]
Shen, Yao [10 ]
Zhang, Yunfeng [11 ]
Ge, Xiahui [12 ]
Sun, Yingxin [3 ]
Zhou, Lei [3 ]
Yu, Suyun [5 ]
Zhao, Kaishun [7 ]
Cheng, Qing [10 ]
Zhu, Xiaodan [1 ]
Liao, Hongen [6 ]
Bai, Chunxue [1 ,13 ,15 ]
Song, Yuanlin [1 ,13 ,14 ,15 ,16 ]
机构
[1] Fudan Univ, Zhongshan Hosp, Dept Pulm Med & Crit Care Med, Shanghai, Peoples R China
[2] Jiaotong Univ, Tong Ren Hosp, Dept Pulm Med, Shanghai, Peoples R China
[3] Fudan Univ, Qingpu Branch, Dept Pulm Med, Zhongshan Hosp, Shanghai, Peoples R China
[4] Pudong New Area Peoples Hosp, Dept Pulm Med, Shanghai, Peoples R China
[5] Fudan Univ, Zhongshan Hosp, Dept Pulm Med, Minhang Branch, Shanghai, Peoples R China
[6] Tsinghua Univ, Sch Med, Dept Biomed Engn, Beijing, Peoples R China
[7] Shanghai Univ Med & Hlth Sci, Dept Pulm Med, Jiading Dist Cent Hosp, Shanghai, Peoples R China
[8] Fudan Univ, Zhongshan Xuhui Hosp, Dept Pulm Med, Shanghai, Peoples R China
[9] Tradit Chinese Med Hosp Kunshan, Dept Pulm Med, Suzhou, Jiangsu, Peoples R China
[10] Pudong Hosp, Dept Pulm Med, Shanghai, Peoples R China
[11] Putuo Dist Liqun Hosp, Dept Pulm Med, Shanghai, Peoples R China
[12] Jiaotong Univ, Shanghai Peoples Hosp 9, Dept Pulm Med, Shanghai, Peoples R China
[13] Fudan Univ, Shanghai Resp Res Inst, Shanghai, Peoples R China
[14] Shanghai Inst Infect Dis & Biosecur, Shanghai, Peoples R China
[15] Fudan Univ, Zhongshan Hosp, Shanghai Key Lab Lung Inflammat & Injury, Shanghai, Peoples R China
[16] Fudan Univ, Zhongshan Hosp, Dept Pulm Med, 180 Fenglin Rd, Shanghai 200032, Peoples R China
关键词
Chronic obstructive pulmonary disease; Noninvasive positive pressure ventilation; Hypercapnia respiratory failure; Internet of things; Telemedicine; OBSTRUCTIVE PULMONARY-DISEASE; POSITIVE-PRESSURE VENTILATION; CLINICAL-OUTCOMES; EXACERBATION;
D O I
10.1016/j.eclinm.2024.102518
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Effective monitoring and management are crucial during long-term home noninvasive positive ventilation (NPPV) in patients with hypercapnic chronic obstructive pulmonary disease (COPD). This investigated the bene fi t of Internet of Things (IOT)-based management of home NPPV. Methods This multicenter, prospective, parallel -group, randomized controlled non -inferiority trial enrolled requiring long-term home NPPV for hypercapnic COPD. Patients were randomly assigned (1:1), via a computer generated randomization sequence, to standard home management or IOT management based telemonitoring of clinical and ventilator parameters over 12 months. The intervention was unblinded, outcome assessment was blinded to management assignment. The primary outcome was the between comparison of the change in health -related quality of life, based on severe respiratory insuff questionnaire scores with a non -inferiority margin of - 5. This study is registered with Chinese Clinical Registry (No. ChiCTR1800019536). Findings Overall, 148 patients (age: 72.7 +/- 6.8 years; male: 85.8%; forced expiratory volume in 1 s: 0.7 +/- 0.3 66.4 +/- 12.0 mmHg), recruited from 11 Chinese hospitals between January 24, 2019, and June 28, 2021, randomly allocated to the intervention group (n = 73) or the control group (n = 75). At 12 months, the mean respiratory insufficiency questionnaire score was 56.5 in the intervention group and 50.0 in the control (adjusted between -group difference: 6.26 [95% CI, 3.71 - 8.80]; P < 0.001), satisfying the hypothesis of non -inferiority. The 12 -month risk of readmission was 34.3% in intervention group compared with 56.0% in the control adjusted hazard ratio of 0.56 (95% CI, 0.34 - 0.92; P = 0.023). No severe adverse events were reported. Interpretation Among stable patients with hypercapnic COPD, using IOT-based management for home NPPV improved health-related quality of life and prolonged the time to readmission.
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页数:14
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