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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)
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.



Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 8 years ]
    Death of all causes

  2. COPD-related mortality [ Time Frame: 8 years ]
    pulmonary, lung cancer and cardiovascular death


Secondary Outcome Measures :
  1. Lung function [ Time Frame: 8 years ]
    forced expiratory volume in one second (FEV1)

  2. 6 minute walking distance [ Time Frame: 8 years ]
    6 minute walking test distance

  3. Severe exacerbations [ Time Frame: 8 years ]
    ER visits or hospitalisations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants were recruited from the outpatient clinic of Chang Gung Memorial Hospital.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Chun-Hua Wang, MD 886 33281200 ext 8470 wchunhua@ms7.hinet.net

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan (r.o.c.), Taiwan, 300
Contact: Hung yu huang, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Hung yu Huang, MD chang gung hospital

Additional Information:

Publications of Results:
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03540862     History of Changes
Other Study ID Numbers: 201600035A3
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Chang Gung Memorial Hospital:
Chronic obstructive pulmonary disease
Maintenance Negative Pressure Ventilation- assisted pulmonary rehabilitation
Six minute walk test
Overall survival

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes