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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Chronic Obstructive Lung Disease | Study protocol

Internet of things-based home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: study protocol for a randomized controlled trial

Authors: Weipeng Jiang, Yuanlin Song

Published in: Trials | Issue 1/2022

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Abstract

Background

Home noninvasive positive pressure ventilation (NIPPV) has 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.

Methods

This multicenter, prospective, randomized controlled trial was conducted with a total of 200 COPD patients with chronic hypercapnic respiratory failure. Using a computer-generated randomization process, patients were randomized (in a 1:1 ratio) into the usual NIPPV (control group) or to receive additional IOT-based management (intervention group) for 12 months. The primary outcome was the Severe Respiratory Insufficiency (SRI) questionnaire. Secondary outcomes included 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.

Discussion

This 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 registration

Chinese Clinical Trials Registry ChiCTR1800019536​. Registered on 17 November 2018.
Appendix
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Metadata
Title
Internet of things-based home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: study protocol for a randomized controlled trial
Authors
Weipeng Jiang
Yuanlin Song
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06372-z

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Commentary

Multiple secondary outcome analyses: precise interpretation is important