Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
Conditions
Keywords
COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training
Brief summary
The aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.
Interventions
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 40-75 years, male or female. 2. Have spirometric evidence of COPD with an FEV1 of \< 50% predicted and FEV1/FVC \< 0.70, measured within the last 6 months (GOLD stage III and IV). Stable disease since 4 weeks or more prior to randomisation. 3. PCO2 of 7 kPa, combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position 4. No treatment with NPPV and respiratory muscle training in the last 8 weeks
Exclusion criteria
1. Smokers can be excluded; 2. Diseases of the lung or thorax besides COPD: OSA Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2 3. Body mass index of 35 kg/m² or above. Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion). 4. Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus. 5. Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Change from Baseline in quality of life at 8 weeks | Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | Change from Baseline in dyspnea at 8 weeks | baseline dyspnea index (BDI)and transition dyspnea index(TDI) |
| Walked distance in 6MWT | Change from Baseline in walked distance at 8 weeks | Change from baseline in distance walked test 6-minute walk test at 8 week |
| Frequency of acute exacerbations of COPD | 8 week | — |
| Pulmonary function tests | Change from Baseline in pulmonary function tests at 8 weeks | — |
| respiratory muscle strength | Change from Baseline in respiratory muscle strength at 8 weeks | — |
| Sleep quality | Change from Baseline in sleep qualityat 8 weeks | Epworth´s Sleepiness Scale |
| Length of hospital admission | 8 week | — |
| frequency of of hospital admission | 8 week | — |
| Blood gases levels | Change from Baseline in blood gases levelsat 8 weeks | — |
Countries
China
Contacts
Primary ContactLuQian Zhou, Doctor
Outcome results
None listed