Clinical trial NCT03540862: Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
Official title: Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Outcome Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic obstructive pulmonary disease
Maintenance Negative Pressure Ventilation- assisted pulmonary rehabilitation
Six minute walk test
Overall survival
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from the outpatient clinic of 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall mortality
timeFrame: 8 years
measure: COPD-related mortality
timeFrame: 8 years
Secondary outcomes:
measure: Lung function
timeFrame: 8 years
measure: 6 minute walking distance
timeFrame: 8 years
measure: Severe exacerbations
timeFrame: 8 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taiwan (r.o.c.)
Study officials:
affiliation: chang gung hospital
name: Hung yu Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang HY, Chou PC, Joa WC, Chen LF, Sheng TF, Lin HC, Yang LY, Pan YB, Chung FT, Wang CH, Kuo HP. Pulmonary rehabilitation coupled with negative pressure ventilation decreases decline in lung function, hospitalizations, and medical cost in COPD: A 5-year study. Medicine (Baltimore). 2016 Oct;95(41):e5119. doi: 10.1097/MD.0000000000005119.
citation: Gorini M, Corrado A, Villella G, Ginanni R, Augustynen A, Tozzi D. Physiologic effects of negative pressure ventilation in acute exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2001 Jun;163(7):1614-8. doi: 10.1164/ajrccm.163.7.2012079.
citation: Waatevik M, Johannessen A, Gomez Real F, Aanerud M, Hardie JA, Bakke PS, Lind Eagan TM. Oxygen desaturation in 6-min walk test is a risk factor for adverse outcomes in COPD. Eur Respir J. 2016 Jul;48(1):82-91. doi: 10.1183/13993003.00975-2015. Epub 2016 Apr 13.