Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT03540862|
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment|
|Pulmonary Disease, Chronic Obstructive||Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||8 Years|
|Official Title:||Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Outcome Analysis|
|Actual Study Start Date :||January 1, 2003|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2022|
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.
Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)
hospital-based NPV once every week as the maintenance program
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.
- Overall mortality [ Time Frame: 8 years ]Death of all causes
- COPD-related mortality [ Time Frame: 8 years ]pulmonary, lung cancer and cardiovascular death
- Lung function [ Time Frame: 8 years ]forced expiratory volume in one second (FEV1)
- 6 minute walking distance [ Time Frame: 8 years ]6 minute walking test distance
- Severe exacerbations [ Time Frame: 8 years ]ER visits or hospitalisations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540862
|Contact: Chun-Hua Wang, MD||886 33281200 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Taipei, Taiwan (r.o.c.), Taiwan, 300|
|Contact: Hung yu huang, MD|
|Principal Investigator:||Hung yu Huang, MD||chang gung hospital|