scholarly journals Correction to: Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Keyword(s):  
Chronic Obstructive ◽  
Invasive Ventilation ◽  
Open Label ◽  
Obstructive Pulmonary Disease ◽  
Non Invasive ◽  
Randomized Controlled ◽  
Home Based ◽  
Copd Patients ◽  
Non Invasive Ventilation

An amendment to this paper has been published and can be accessed via the original article.

scholarly journals Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Keyword(s):  
Chronic Obstructive ◽  
Invasive Ventilation ◽  
Open Label ◽  
Obstructive Pulmonary Disease ◽  
Free Survival ◽  
Non Invasive ◽  
Randomized Controlled ◽  
Copd Patients ◽  
Non Invasive Ventilation

AbstractChronic obstructive pulmonary disease (COPD) is expected to be the 3rd leading cause of death worldwide by 2020. Despite improvements in survival by using acute non-invasive ventilation (NIV) to treat patients with exacerbations of COPD complicated by acute hypercapnic respiratory failure (AHRF), these patients are at high risk of readmission and further life-threatening events, including death. Recent studies suggested that NIV at home can reduce readmissions, but in a small proportion of patients, and with a high level of expertise. Other studies, however, do not show any benefit of home NIV. This could be related to the fact that respiratory failure in patients with stable COPD and their response to mechanical ventilation are influenced by several pathophysiological factors which frequently coexist in the same patient to varying degrees. These pathophysiological factors might influence the success of home NIV in stable COPD, thus long-term NIV specifically adapted to a patient’s “phenotype” is likely to improve prognosis, reduce readmission to hospital, and prevent death. In view of this conundrum, Rescue2-monitor (R2M), an open-label, prospective randomized, controlled study performed in patients with hypercapnic COPD post-AHRF, will investigate the impact of the quality of nocturnal NIV on the readmission-free survival. The primary objective is to show that any of 3 home NIV strategies (“rescue,” “non-targeted,” and “targeted”) will improve readmission-free survival in comparison to no-home NIV. The “targeted” group of patients will receive a treatment with personalized (targeted) ventilation settings and extensive monitoring. Furthermore, the influence of comorbidities typical for COPD patients, such as cardiac insufficiency, OSA, or associated asthma, on ventilation outcomes will be taken into consideration and reasons for non-inclusion of patients will be recorded in order to evaluate the percentage of ventilated COPD patients that are screening failures. ClinicalTrials.gov NCT03890224. Registered on March 26, 2019.

scholarly journals Extracorporeal carbon dioxide removal for treatment of exacerbated chronic obstructive pulmonary disease (ORION): study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tommaso Tonetti ◽  
Lara Pisani ◽  
Irene Cavalli ◽  
Maria Laura Vega ◽  
Elisa Maietti ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Chronic Obstructive ◽  
Invasive Ventilation ◽  
Obstructive Pulmonary Disease ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Acute Exacerbations

Abstract Background Hypercapnic exacerbations are severe complications of chronic obstructive pulmonary disease (COPD), characterized by negative impact on prognosis, quality of life and healthcare costs. The present standard of care for acute exacerbations of COPD is non-invasive ventilation; when it fails, the use of invasive mechanical ventilation is inevitable, but is associated with extremely poor prognosis. Extracorporeal circuits designed to remove CO2 (ECCO2R) may enhance the efficacy of NIV to remove CO2 and avoid the worsening of respiratory acidosis, which inevitably leads to failure of non-invasive ventilation. Although the use of ECCO2R for acute exacerbations of COPD is steadily increasing, solid evidence on its efficacy and safety is scarce, thus the need for a randomized controlled trial. Methods multicenter randomized controlled unblinded clinical trial including 284 (142 per arm) patients with acute hypercapnic respiratory failure caused by exacerbation of COPD, requiring respiratory support with NIV. The primary outcome is event free survival at 28 days, a composite outcome defined by survival in absence of prolonged mechanical ventilation, severe hypoxemia, septic shock and second episode of COPD exacerbation. Secondary outcomes are incidence of endotracheal intubation and tracheostomy, intensive care and hospital length-of-stay and 90-day mortality. Discussion Acute exacerbations of COPD represent a significant burden in terms of prognosis, quality of life and healthcare costs. Lack definite evidence despite increasing use of ECCO2R justifies a randomized trial to evaluate whether patients with acute hypercapnic acidosis not responsive to NIV should undergo invasive mechanical ventilation (with all serious related risks) or be treated with ECCO2R to avoid invasive ventilation but be exposed to possible adverse events of ECCO2R. Owing to its pragmatic nature, sample size and composite primary outcome, this trial aims at providing valuable answers to relevant questions for clinical treatment of acute exacerbations of COPD. Trial registration ClinicalTrials.gov, NCT04582799. Registered 12 October 2020, .

scholarly journals Intermittent Use of Portable NIV Increases Exercise Tolerance in COPD: A Randomised, Cross-Over Trial

2019 ◽  
Vol 8 (1) ◽  
pp. 94 ◽  
Author(s):  
Ioannis Vogiatzis ◽  
Nikolaos Chynkiamis ◽  
Matthew Armstrong ◽  
Nicholas Lane ◽  
Tom Hartley ◽  
...  
Keyword(s):  
Exercise Tolerance ◽  
Moderate Intensity ◽  
Chronic Obstructive ◽  
Dynamic Hyperinflation ◽  
Invasive Ventilation ◽  
Inspiratory Capacity ◽  
Obstructive Pulmonary Disease ◽  
Non Invasive ◽  
Copd Patients ◽  
Non Invasive Ventilation

During exercise, non-invasive ventilation (NIV) prolongs endurance in chronic obstructive pulmonary disease (COPD), but routine use is impractical. The VitaBreath device provides portable NIV (pNIV); however, it can only be used during recovery. We assessed the effect of pNIV compared to pursed lip breathing (PLB) on exercise tolerance. Twenty-four COPD patients were randomised to a high-intensity (HI: 2-min at 80% peak work rate (WRpeak) alternated with 2-min recovery; n = 13), or a moderate-intensity (MOD: 6-min at 60% WRpeak alternated with 2-min recovery; n = 11) protocol, and within these groups two tests were performed using pNIV and PLB during recovery in balanced order. Upon completion, patients were provided with pNIV; use over 12 weeks was assessed. Compared to PLB, pNIV increased exercise tolerance (HI: by 5.2 ± 6.0 min; MOD: by 5.8 ± 6.7 min) (p < 0.05). With pNIV, mean inspiratory capacity increased and breathlessness decreased by clinically meaningful margins during recovery compared to the end of exercise (HI: by 140 ± 110 mL and 1.2 ± 1.7; MOD: by 170 ± 80 mL and 1.0 ± 0.7). At 12 weeks, patients reported that pNIV reduced anxiety (median: 7.5/10 versus 4/10, p = 0.001) and recovery time from breathlessness (17/24 patients; p = 0.002); 23/24 used the device at least weekly. pNIV increased exercise tolerance by reducing dynamic hyperinflation and breathlessness in COPD patients.

scholarly journals Cost-effectiveness of home non-invasive ventilation in COPD group GOLD D patients

2021 ◽  
pp. 327-332
Author(s):  
Enikő BERES ◽  
Katalin BABES ◽  
Zsolt-Levente BERES ◽  
Lucia Georgeta DAINA ◽  
Cristian Marius DAINA ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Quality Adjusted Life Year ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Invasive Ventilation ◽  
Obstructive Pulmonary Disease ◽  
Non Invasive ◽  
Copd Patients ◽  
Non Invasive Ventilation ◽  
Quality Adjusted Life

Introduction. Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, estimated to be the third most common cause of death by 2020. The natural evolution of the disease is characterized by frequent exacerbations, severe exacerbations evolving with respiratory acidosis. Introducing home non-invasive ventilation (NIV) in the management of COPD group GOLD (Global Initiative for Chronic Obstructive Lung Disease) D patients generates supplementary costs, but the decreasing of the number of severe exacerbations will decrease the costs of drug treatment and hospitalization. This balance can be verified through a careful study of cost-effectiveness through modern methods of assessing the costs and years of life gained in relation to quality of life. Material and method. This prospective study took place in the Emergency Department of the Bihor County Clinical Emergency Hospital, Oradea, between 01 October 2017 – 31 October2018, with a follow-up period of 2 years. We included 36 Group risk D COPD patients, presented with severe exacerbation that required NIV; the patients were divided into two study groups according to the treatment scheme after discharge (standard medication according to GOLD guidelines and long-term oxygen therapy - LTOT vs. LTOT + NIV). We follow-up at 2 years with the study group, and analyze the following: number of exacerbations (moderate and severe), number of hospitalizations, mortality rate in two years, average costs for the treatment of exacerbations and for stable COPD periods, quality adjusted life year (QALY). Results and discussions. From 36 enrolled, 10 patients benefited from home NIV. The number of exacerbations was significantly lower in the NIV group compared with the LTOT group (1.72±0.79 vs 3.54±1.18). The incremental cost-effectiveness ratio (ICER) showed a net gain of 31% from gross product (GDP) per capita (5,641.71 ± 1,737.0-euro vs 9,272.3 ± 3,681.9 euro) per quality adjusted life year (QALY) for each patient. Conclusions. Introduction home-NIV demonstrated clinical improvement and higher cost-effectiveness over LTOT alone in Class Risk D, COPD patients after discharge following a severe exacerbation. Keywords: chronic obstructive pulmonary disease, non-invasive ventilation, cost-effectiveness, quality adjusted life year,

scholarly journals Home use of Non-invasive Ventilation for chronic obstructive pulmonary disease. Literature Review and Update.

2021 ◽  
Vol 2 (2) ◽  
pp. 59-63
Author(s):  
Kimiyo Yamasaki
Keyword(s):  
High Intensity ◽  
New Technology ◽  
Chronic Obstructive ◽  
Invasive Ventilation ◽  
Obstructive Pulmonary Disease ◽  
Admission Rates ◽  
Non Invasive ◽  
Copd Patients ◽  
Non Invasive Ventilation ◽  
New Research

Non-invasive ventilation use in acute COPD exacerbation and acute respiratory failure is very strong, however the evidence beyond home non-invasive ventilation for COPD patients is less clear. In this review we summarize the literature on the effectiveness of home non-invasive ventilation on mortality, hospital admission rates, quality of life, lung functions, gas exchange, exercise tolerance as well as mood and anxiety. Published guidelines from multiple societies mostly give weak and conditional guidelines on the use of home non-invasive ventilation. High intensity home non-invasive ventilation was recently introduced and may further improve the outcomes. New research regarding high intensity home non-invasive ventilation and new technology are needed to define the role and the benefits of home non-invasive ventilation in patients with COPD. Keywords: Home non-invasive ventilation, COPD, GOLD

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