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

Weipeng Jiang; Xiaoyan Jin; Chunling Du; Wenchao Gu; Xiwen Gao; Chenjun Zhou; Chunlin Tu; Hongqun Chen; Hong Li; Yao Shen; Yunfeng Zhang; Xiahui Ge; Yingxin Sun; Lei Zhou; Suyun Yu; Kaishun Zhao; Qing Cheng; Xiaodan Zhu; Hongen Liao; Chunxue Bai; Yuanlin Song

doi:10.1016/j.eclinm.2024.102518

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

EClinicalMedicine. 2024 Mar 10:70:102518. doi: 10.1016/j.eclinm.2024.102518. eCollection 2024 Apr.

Authors

Weipeng Jiang¹, Xiaoyan Jin², Chunling Du³, Wenchao Gu⁴, Xiwen Gao⁵, Chenjun Zhou⁶, Chunlin Tu⁷, Hongqun Chen⁸, Hong Li⁹, Yao Shen¹⁰, Yunfeng Zhang¹¹, Xiahui Ge¹², Yingxin Sun³, Lei Zhou³, Suyun Yu⁵, Kaishun Zhao⁷, Qing Cheng¹⁰, Xiaodan Zhu¹, Hongen Liao⁶, Chunxue Bai^{1

13}, Yuanlin Song^{1

13

14

15}

Affiliations

¹ Department of Pulmonary Medicine and Critical Care Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
² Department of Pulmonary Medicine, Tong Ren Hospital, Jiaotong University, Shanghai, China.
³ Department of Pulmonary Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, China.
⁴ Department of Pulmonary Medicine, Pudong New Area People's Hospital, Shanghai, China.
⁵ Department of Pulmonary Medicine, Minhang Branch of Zhongshan Hospital, Fudan University, Shanghai, China.
⁶ Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing, China.
⁷ Department of Pulmonary Medicine, Jiading District Central Hospital Affiliated Shanghai University of Medicine &Health Sciences, Shanghai, China.
⁸ Department of Pulmonary Medicine, Zhongshan Xuhui Hospital, Fudan University, Shanghai, China.
⁹ Department of Pulmonary Medicine, Traditional Chinese Medicine Hospital of Kunshan, Jiangsu, China.
¹⁰ Department of Pulmonary Medicine, Pudong Hospital, Shanghai, China.
¹¹ Department of Pulmonary Medicine, Putuo District Liqun Hospital, Shanghai, China.
¹² Department of Pulmonary Medicine, Shanghai Ninth People's Hospital, Jiaotong University, Shanghai, China.
¹³ Shanghai Respiratory Research Institute, Fudan University, Shanghai, China.
¹⁴ Shanghai Institute of Infectious Disease and Biosecurity, Shanghai, China.
¹⁵ Shanghai Key Laboratory of Lung Inflammation and Injury, Zhongshan Hospital, Fudan University, Shanghai, China.

Abstract

Background: Effective monitoring and management are crucial during long-term home noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic chronic obstructive pulmonary disease (COPD). This study investigated the benefit of Internet of Things (IOT)-based management of home NPPV.

Methods: This multicenter, prospective, parallel-group, randomized controlled non-inferiority trial enrolled patients 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 on telemonitoring of clinical and ventilator parameters over 12 months. The intervention was unblinded, but outcome assessment was blinded to management assignment. The primary outcome was the between-group comparison of the change in health-related quality of life, based on severe respiratory insufficiency questionnaire scores with a non-inferiority margin of -5. This study is registered with Chinese Clinical Trials 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 L; PaCO₂: 66.4 ± 12.0 mmHg), recruited from 11 Chinese hospitals between January 24, 2019, and June 28, 2021, were randomly allocated to the intervention group (n = 73) or the control group (n = 75). At 12 months, the mean severe respiratory insufficiency questionnaire score was 56.5 in the intervention group and 50.0 in the control group (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 group, 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.

Funding: Air Liquide Healthcare (Beijing) Co., Ltd.

Keywords: Chronic obstructive pulmonary disease; Hypercapnia respiratory failure; Internet of things; Noninvasive positive pressure ventilation; Telemedicine.