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Randomized Controlled Trial
. 2017 Apr 27:12:1279-1286.
doi: 10.2147/COPD.S127540. eCollection 2017.

Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial

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 Chen  1
Affiliations
Randomized Controlled Trial

Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial

Luqian Zhou et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

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; built-in software; chronic respiratory failure; long-term oxygen therapy; noninvasive positive pressure ventilation.

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Conflict of interest statement

Disclosure The authors received financial support from Curative Medical Co. China for the research. The authors report no other conflicts of interests in this work.

Figures

Figure 1
Figure 1
Scatter plot of leak recorded in built-in software. Abbreviations: MV, minute volume; Vt, tidal volume; BPM, breath per minuter; IT, inspiratory time.
Figure 2
Figure 2
Parameters recorded in built-in software. Abbreviations: MV, minute volume; Vt, tidal volume; BPM, breath per minuter; IT, inspiratory time.
Figure 3
Figure 3
CONSORT flow diagram. Abbreviations: CONSORT, consolidated standards of reporting trials; LTOT, long-term oxygen therapy; NPPV, noninvasive positive pressure ventilation.
Figure 4
Figure 4
Bland-Altman plots for absolute reliability of parameters estimation between the Flexo and LabChart. Notes: (A) Bland–Altman plots for absolute reliability (means vs differences) of leak estimation between the Flexo and LabChart. (B) Bland–Altman plots for absolute reliability (means vs differences) of pressure estimation between the Flexo and LabChart. Abbreviation: SD, standard deviation.
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