Abstract
BackgroundHome noninvasive positive pressure ventilation (NIPPV) have become evidence-based care for stable hypercapnic chronic obstructive pulmonary disease (COPD) patients. There are still other challenges including appropriate follow-up, telemonitor and management to ensure treatment effectiveness, compliance and security, and to improve quality of life. The Internet of Things (IOT) is the name given to the network of devices and other “things” with built-in sensors, software, electronics and network connectivity, communicating these objects over wireless networks and sending data to a cloud platform. The study aims to evaluate the effectiveness and safety of the IOT-based management of NIPPV for the COPD patients with hypercapnic chronic respiratory failure.MethodsThis multicenter, prospective, randomized controlled trial will be conducted with a total of 200 COPD patients with chronic hypercapnic respiratory failure. Using a computer-generated randomization process, patients will be randomized (in a 1:1 ratio) into usual NIPPV (control group) or to receive additional IOT-based management (intervention group) for 12 months. The primary outcome is Severe Respiratory Insufficiency (SRI) questionnaire. Secondary outcomes include compliance with the ventilator, gas exchange, lung function, Health-related Quality of Life, hospitalization frequency, time to death within 1-year, all-cause mortality, safety analysis and cost-effectiveness analysis.DiscussionThis study will be the first and largest randomized trial in China to evaluate the effectiveness and safety of the IOT-based management of NIPPV for COPD patients with chronic hypercapnic respiratory failure. The results will help to understand the current situation of IOT based home ventilation and may provide new evidence for home NIPPV treatment and management in the future.Trial registrationChinese Clinical Trials Registry ChiCTR1800019536. Registered 17 November, 2018.
Domiciliary nocturnal nasal intermittent positive pressure ventilation in hypercapnic respiratory failure due to chronic obstructive lung disease: effects on sleep and quality of life.