Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT03540862
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2003-01-01
• Status Verified: 2018-05
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-30
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01
• Primary Completion: 2020-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COPD-related mortality	8 years	pulmonary, lung cancer and cardiovascular death
Overall mortality	8 years	Death of all causes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan (r.o.c.), Taiwan