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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03540862
Enrollment
500
Registered
2018-05-30
Start date
2003-01-01
Completion date
2022-12-30
Last updated
2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

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

DEVICEmaintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)

hospital-based NPV once every week as the maintenance program

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Overall mortality8 yearsDeath of all causes
COPD-related mortality8 yearspulmonary, lung cancer and cardiovascular death

Secondary

MeasureTime frameDescription
Lung function8 yearsforced expiratory volume in one second (FEV1)
6 minute walking distance8 years6 minute walking test distance
Severe exacerbations8 yearsER visits or hospitalisations

Countries

Taiwan

Contacts

Primary ContactChun-Hua Wang, MD
wchunhua@ms7.hinet.net886 33281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026