Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial
Received 13 November 2016
Accepted for publication 19 February 2017
Published 27 April 2017 Volume 2017:12 Pages 1279—1286
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Professor Hsiao-Chi Chuang
Peer reviewer comments 4
Editor who approved publication: Dr Richard Russell
Luqian Zhou,1,* Xiaoying Li,1,* Lili Guan,1,* Jianhua Chen,1 Bingpeng Guo,1 Weiliang Wu,1 Yating Huo,1 Ziqing Zhou,1 Zhenyu Liang,1 Yuqi Zhou,2 Jie Tan,3 Xin Chen,4 Yuanlin Song,5 Rongchang Chen1
1Department of Respiratory Medicine, State Key Laboratory of Respiratory Disease, Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, 2Department of Respiratory Medicine, The Third Affiliated Hospital of Sun-Yat Sen University, 3Department of Respiratory Medicine, The First Affiliated Hospital, School of Clinical Medicine of Guangzhou Pharmaceutical University, 4Department of Respiratory Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, 5Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China
*These authors contributed equally to this work
Background: The benefits of noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic COPD are controversial. It is presumed that methodology and appropriate use of NIV ventilator might be crucial for the outcomes. With the new built-in software, the performance of NIV can be monitored at home, which can guarantee the compliance and appropriate use. This study investigated effects of home use of NIV in hypercapnia in COPD patients using the NIV ventilator with built-in software for monitoring.
Methods: The current multicenter prospective, randomized, controlled trial enrolled patients with stable GOLD stages III and IV hypercapnic COPD. Patients were randomly assigned via a computer-generated randomization sequence, with a block size of four patients, to continue optimized treatment (control group) or to receive additional NPPV (intervention group) for 3 months. The primary outcome was arterial carbon dioxide pressure (PaCO2). Data were derived from built-in software and analyzed every 4 weeks. Analysis was carried out with the intention to treat. This study is registered with ClinicalTrials.gov, number NCT02499718.
Results: Patients were recruited from 20 respiratory units in China from October 1, 2015, and recruitment was terminated with a record of the vital statistics on May 31, 2016. A total of 115 patients were randomly assigned to the NPPV group (n=57) or the control group (n=58). Patients complied well with NPPV therapy (mean [± standard deviation] day use 5.6±1.4 h). The mean estimation of leaks was 37.99±13.71 L/min. The changes in PaCO2 (-10.41±0.97 vs -4.32±0.68 mmHg, P=0.03) and 6-min walk distance (6MWD) (38.2% vs 18.2%, P=0.02) were statistically significant in the NPPV group versus the control group. COPD assessment test (CAT) showed a positive trend (P=0.06) in favor of the NPPV group. Pulmonary function and dyspnea were not different between groups.
Conclusion: Ventilators equipped with built-in software provided methodology for monitoring NIV use at home, which could facilitate the improvement of compliance and quality control of NIV use. It was shown that three months use of NIV at home could reduce the PaCO2 and improve exercise tolerance (6MWD) in chronic hypercapnic COPD patients.
Keywords: COPD, noninvasive positive pressure ventilation, long-term oxygen therapy, chronic respiratory failure, built-in software
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