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

2021 ◽  
Author(s):  
Weipeng Jiang ◽  
Yuanlin Song
Keyword(s):  
Quality Of Life ◽  
Respiratory Failure ◽  
Positive Pressure Ventilation ◽  
Controlled Trial ◽  
Noninvasive Positive Pressure Ventilation ◽  
Positive Pressure ◽  
Hypercapnic Respiratory Failure ◽  
Randomized Controlled ◽  
Copd Patients

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.

scholarly journals Non-invasive positive pressure ventilation in acute hypercapnic respiratory failure: clinical experience of a respiratory ward

2004 ◽  
Vol 61 (2) ◽  
Author(s):  
R. Scala ◽  
M. Naldi ◽  
I. Archinucci ◽  
G. Coniglio
Keyword(s):  
Clinical Practice ◽  
Respiratory Failure ◽  
Standard Therapy ◽  
Positive Pressure Ventilation ◽  
Controlled Trial ◽  
Positive Pressure ◽  
Hypercapnic Respiratory Failure ◽  
Non Invasive ◽  
Arterial Blood ◽  
Acute Hypercapnic Respiratory Failure

Background: Although a controlled trial demonstrated that non-invasive positive pressure ventilation (NIV) can be successfully applied to a respiratory ward (RW) for selected cases of acute hypercapnic respiratory failure (AHRF), clinical practice data about NIV use in this setting are limited. The aim of this observational study is to assess the feasibility and efficacy of NIV applied to AHRF in a RW in everyday practice. Methods: Twenty-two percent (216/984) of patients consecutively admitted for AHRF to our RW in Arezzo (years: 1996-2003) received NIV in addition to standard therapy, according to pre-defined routinely used criteria. Tolerance, effects upon arterial blood gases (ABG), success rate (avoidance a priori criteria for intubation) and predictors of failure of NIV were analysed. Results: Nine patients (4.2%) were found to be intolerant to NIV, while the remaining 207 (M: 157, F: 50; mean (SD) age: 73.2 (8.9) yrs; COPD: 71.5%) were ventilated for >1 hour. ABG significantly improved after two hours of NIV (pH: 7.32 (0.06) versus median (Interquartiles) 7.28 (7.24-7.31), p<0.0001; PaCO2: 71.9 (13.5) mmHg versus 80.0 (15.2) mmHg, p<0.0001; PaO2/FiO2: 212 (66) versus 184 (150-221), p<0.0001). NIV succeeded in avoiding intubation in 169/207 patients (81.6%) with hospital mortality of 15.5%. NIV failure was independently predicted by Activity of Daily Living score, pneumonia as cause of AHRF and Acute Physiology and Chronic Health Evaluation III score. Conclusions: In clinical practice NIV is feasible, effective in improving ABG and useful in avoiding intubation in most AHRF episodes that do not respond to the standard therapy managed in an RW adequately trained in NIV.

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