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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPV | a hospital-based maintenance NPV program including NPV support, breathing training and an educational program (relaxation techniques, and home pacing walking exercise) in daily clinical practice. Patients received NPV with breathing training via the cuirass ventilator (Philips Respironics Lifecare NEV-100) settings for 60 min. The ventilator was set to control model with frequency of 12 cycles/min, 30% of the ratio of inspiratory time to total breathing cycle time (Ti/Ttot) and delivered negative pressures ranging -20 to -30 cm H2O. In the NPV group, patients underwent the hospital-based NPV once every week as the maintenance program. |
| |
| Control | If patients do not wish to enter the hospital-based NPV program, they are placed in the control group and are trained to perform breathing training, relaxation techniques and home pacing walking exercise. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100) | Device | hospital-based NPV once every week as the maintenance program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | Death of all causes | 8 years |
| COPD-related mortality | pulmonary, lung cancer and cardiovascular death | 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function | forced expiratory volume in one second (FEV1) | 8 years |
| 6 minute walking distance | 6 minute walking test distance | 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited from the outpatient clinic of Chang Gung Memorial Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun-Hua Wang, MD | Contact | 886 33281200 | 8470 | wchunhua@ms7.hinet.net |
| Name | Affiliation | Role |
|---|---|---|
| Hung yu Huang, MD | chang gung hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taipei | Taiwan (r.o.c.) | 300 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741132 | Result | 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. | |
| 11401883 |
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| Severe exacerbations | ER visits or hospitalisations | 8 years |
| 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. |
| 27076586 | Result | 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. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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