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

NCT ID: NCT04843696

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2024-12-31

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.

Detailed Description

Pulmonary rehabilitation (PR) has been suggested to be positive effects on 6 min walking distance (6MWD), muscle force, cycle exercise endurance time, and quality of life. However, the literature still could not explain the role of PR in reducing systemic inflammation of chronic obstruction pulmonary disease (COPD) patients. A recent study found that PR with negative pressure ventilation (NPV) improved lung function, exercise capacity and reduced acute exacerbation rates in COPD patients. The objectives of this research are to design a prospective, randomized controlled trial to determine the clinical outcome of NPV-PR in COPD patients and to investigate if NPV-PR reduces systemic inflammation in patients with COPD.

This investigator-initiated, prospective, single center, randomized, controlled clinical trial enrolled patients with stable Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV COPD. NPV was targeted to reduce baseline blood carbon dioxide by at least 20% during NPV titration. Patients were randomly assigned (in a 1:1 ratio) to continue optimised standard treatment (control group) or to receive additional NPV-PR for at least 24 months (intervention group). The primary outcome was 2-year acute exacerbation rates. The lung function and walking distance will be assessed by six-minute walking tests and the severity of disease will be evaluated by high resolution computed tomography scores. Peripheral blood sample will be collected to analyze the inflammatory cytokines and oxidative markers.

In the present prospective study, investigators hypothesize that NPV-PR would be superior to usual care in reducing the risk for acute exacerbations of COPD, hospitalisations and emergency visits over a 24-month period. This research will provide evidence for the role of NPV-PR in the management of COPD, and evidence for a role of systemic inflammation in disease progression of COPD. The results may provide certain insights into more effective treatments to inhibit the disease progression of COPD.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation of COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPV group

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Interventions

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

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.

Intervention Type: DEVICE

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

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung Yu Huang

Role: CONTACT

b9202071@cgmh.org.tw

+ 886 33281200 ext. 8470

Facility Contacts

Hung Yu Huang

Role: primary

b9202071@cgmh.org.tw

+ 886 33281200 ext. 8470

References

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.

Reference Type: BACKGROUND

PMID: 31027263 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27741132 (View on PubMed)

Other Identifiers

201902168B0

Identifier Type: -

Identifier Source: org_study_id