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. 2022 May 12;23(1):393.
doi: 10.1186/s13063-022-06372-z.

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

Weipeng Jiang  1 , Yuanlin Song  2   3   4   5   6
Affiliations

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

Weipeng Jiang et al. Trials. .

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.

Keywords: Chronic obstructive pulmonary disease; Follow-up; Hypercapnia respiratory failure; Internet of things; Management; Noninvasive positive pressure ventilation; Tele-monitoring.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
IOT-based management of NIPPV
Fig. 2
Fig. 2
The IOT cloud platform. BPM, breaths per minute; VT, tidal volume
Fig. 3
Fig. 3
The study flow diagram. NIPPV, noninvasive positive pressure ventilation; COPD, chronic obstructive pulmonary disease; IOT, Internet of things; CHRF, chronic hypercapnic respiratory failure
See this image and copyright information in PMC

References

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