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

NCT03540862 | Unknown FDA Device

• 1 other identifier: 201600035A3
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic obstructive pulmonary disease; Maintenance Negative Pressure Ventilation- assisted pulmonary rehabilitation; Six minute walk test; Overall survival

Outcome Measures

Primary Outcomes (2)

• Overall mortality

  Death of all causes

  8 years

• COPD-related mortality

  pulmonary, lung cancer and cardiovascular death

  8 years

Secondary Outcomes (3)

• Lung function

  8 years

• 6 minute walking distance

  8 years

• Severe exacerbations

  8 years

Study Arms (2)

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)

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.

Interventions

maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100) DEVICE

hospital-based NPV once every week as the maintenance program

NPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Main diagnosis of Chronic Obstructive Pulmonary Disease
• Stable status at enrollment
• Able to come to pulmonary rehab center

You may not qualify if:

• Infection or acute excerbation condition at enrollment
• Severe neuromuscular, cardiac disease or dementia
• Unable to perform six minute walk test

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan (r.o.c.), 300, Taiwan

RECRUITING

Related Publications (3)

• 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.

  PMID: 27741132 RESULT

• 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.

  PMID: 11401883 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.

  PMID: 27076586 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hung yu Huang, MD

  chang gung hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hua Wang, MD

CONTACT

886 33281200; wchunhua@ms7.hinet.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: January 1, 2003
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2022
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)