Negative Pressure Ventilation-rehabilitation on Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT04843696 | Unknown

• 1 other identifier: 201902168B0
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease stage II-IV chronic obstruction pulmonary disease. The primary outcome was 2-year acute exacerbation rates.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation of COPD

Keywords

Chronic obstructive pulmonary disease; Negative-pressure ventilation; Acute Exacerbation

Outcome Measures

Primary Outcomes (1)

• COPD acute exacerbations rate

  mild (required treatment with oral/systemic corticosteroids and/or antibiotics, without hospitalization) moderate (required treatment with oral/systemic corticosteroids and/or antibiotics, with emergency department visits) severe (required in-patient hospitalization)

  2 years

Secondary Outcomes (3)

• the yearly rate of decline of forced expiratory volume in 1 second (FEV1)

  2 years

• the yearly rate of decline of 6 minute walking distance (6MWD)

  2 years

• Mortality

  2 years

Study Arms (2)

NPV group

EXPERIMENTAL

The hospital-based maintenance NPV program includes NPV support, breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice. The patients in the NPV group undergo the hospital-based NPV once per week in the maintenance program at least three times per month. The patients received NPV with breathing training via a cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) for 60 min, once per week. Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing).

Device: cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy); Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)

Control group

ACTIVE COMPARATOR

Control group receives breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) in daily clinical practice. Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing).

Behavioral: breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)

Interventions

cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy) DEVICE

the hospital-based NPV once per week in the maintenance program at least three times per month. The ventilator is set to the control model with a frequency of 12\~15 cycles/min, 30% of the ratio of inspiratory time to total breathing cycle time (Ti/Ttot), and delivery of negative pressures ranging from -20 to -35 cm H2O.

NPV group

breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) BEHAVIORAL

breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing)

Control group; NPV group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COPD ((post-bronchodilation forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) \<0.7)
• Optimal medical treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)) at least 3 months before screening

You may not qualify if:

• abnormalities of the thorax or the lung other than COPD,
• acute exacerbation within one month
• obesity with a body-mass index (BMI) ≥35 kg/m²,
• malignant co-morbidities, severe heart failure (New York Heart Association stage IV), unstable angina, severe arrhythmias, neuromuscular diseases and/or impairment of basal brain nerve function with disturbed swallowing and choking and impaired general condition that could preclude regular follow-up visits.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (2)

• Huang HY, Lo CY, Yang LY, Chung FT, Sheng TF, Lin HC, Lin CW, Huang YC, Chang CJ, Chung KF, Wang CH. Maintenance Negative Pressure Ventilation Improves Survival in COPD Patients with Exercise Desaturation. J Clin Med. 2019 Apr 25;8(4):562. doi: 10.3390/jcm8040562.

  PMID: 31027263 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Hung Yu Huang

CONTACT

+ 886 33281200; b9202071@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 13, 2021
• Study Start: April 8, 2021
• Primary Completion: April 10, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)