Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic obstructive pulmonary disease, Maintenance Negative Pressure Ventilation- assisted pulmonary rehabilitation, Six minute walk test, Overall survival
Brief summary
Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow obstruction with chronic airway inflammation and emphysematous changes in the lung parenchyma, thus leading to air-trapping, as well as extional dyspnea. The investigators have previously observed that NPV used as an adjuvant to pulmonary rehabilitation improves lung function, exercise capacity, and reduces exacerbations. The investigators now sought to determine whether long-term maintenance NPV improves long-term clinical outcomes and reduces mortality in COPD.
Detailed description
Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airflow obstruction with chronic airway inflammation and emphysematous changes in the lung parenchyma, thus leading to air-trapping, as well as extional dyspnea. The mechanism underlying desaturation during 6MWT in patients with COPD is multifactorial involving dynamic hyperinflation and impaired gas exchange that worsens ventilation-perfusion mismatch. Previous studies have shown that oxygen desaturation during the 6MWT predicts mortality and increases the risk of adverse outcomes in COPD patients. However, there is a paucity of studies that have looked at effective treatments to counter the consequences of hypoxemia during exertion. The investigators have established a hospital-based maintenance pulmonary rehabilitation program together with NPV for COPD, and the investigators have shown that the benefits of NPV improves lung function and exercise capacity, and reduces acute exacerbation and medical costs. The investigators now sought to determine whether long-term maintenance NPV improves long-term clinical outcomes and reduces mortality in COPD.
Interventions
hospital-based NPV once every week as the maintenance program
Sponsors
Study design
Eligibility
Inclusion criteria
* Main diagnosis of Chronic Obstructive Pulmonary Disease * Stable status at enrollment * Able to come to pulmonary rehab center
Exclusion criteria
* Infection or acute excerbation condition at enrollment * Severe neuromuscular, cardiac disease or dementia * Unable to perform six minute walk test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | 8 years | Death of all causes |
| COPD-related mortality | 8 years | pulmonary, lung cancer and cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function | 8 years | forced expiratory volume in one second (FEV1) |
| 6 minute walking distance | 8 years | 6 minute walking test distance |
| Severe exacerbations | 8 years | ER visits or hospitalisations |
Countries
Taiwan