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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

Tracking Information
First Submitted Date May 17, 2018
First Posted Date May 30, 2018
Last Update Posted Date June 1, 2018
Actual Study Start Date January 1, 2003
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
  • Overall mortality [ Time Frame: 8 years ]
    Death of all causes
  • COPD-related mortality [ Time Frame: 8 years ]
    pulmonary, lung cancer and cardiovascular death
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03540862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 17, 2018)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 8 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants were recruited from the outpatient clinic of Chang Gung Memorial Hospital.
Condition Pulmonary Disease, Chronic Obstructive
Intervention Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)
hospital-based NPV once every week as the maintenance program
Study Groups/Cohorts
  • 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.
    Intervention: Device: maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 17, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Chun-Hua Wang, MD 886 33281200 ext 8470 wchunhua@ms7.hinet.net
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03540862
Other Study ID Numbers 201600035A3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Hung yu Huang, MD chang gung hospital
PRS Account Chang Gung Memorial Hospital
Verification Date May 2018