Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease

Negative Pressure Ventilator in Long-term Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease: Outcome Analysis

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Chun-Hua Wang, MD; Phone Number: 8470 886 33281200; Email: wchunhua@ms7.hinet.net

Study Locations

• Taiwan
  • Taiwan (r.o.c.)
    • Taipei, Taiwan (r.o.c.), Taiwan, 300
      • Recruiting
      • Chang Gung Memorial Hospital
      • Contact: Hung yu huang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from the outpatient clinic of Chang Gung Memorial Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Death of all causes	8 years
COPD-related mortality	pulmonary, lung cancer and cardiovascular death	8 years

Secondary Outcome Measures

Outcome Measure	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
Severe exacerbations	ER visits or hospitalisations	8 years

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Hung yu Huang, MD, Chang Gung Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease; Overall survival; Six minute walk test; Maintenance Negative Pressure Ventilation- assisted pulmonary rehabilitation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 201600035A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No