Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD
Overview
- Phase
- Phase 4
- Intervention
- Control
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Hospital Universitario La Paz
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- daily physical activity and plasmatic concentration of C-reactive protein
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with stable COPD.
Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive protein concentration and daily physical activity in hypercapnic patients with stable COPD.
Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers between COPD patients with conventional treatment and wich noninvasive ventilation. To determine the response of breathlessness, health-related quality of life and lung function to noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic response to noninvasive ventilation.
Investigators
Francisco Garcia-Rio
MD
Hospital Universitario La Paz
Eligibility Criteria
Inclusion Criteria
- •Age: 45-75 yrs.
- •COPD diagnosis (postbronchodilator FEV1/FVC \< 0.7) for at least 6 months.
- •FEV1 \< 45% predicted
- •Baseline pH 7.35-7.45
- •Baseline PaCO2\>45 mmHg breathing current air
- •Smoking history (\>15 pack-year)
- •Clinically stable for at least the last three months
- •Pharmacological treatment optimized in the last two years.
Exclusion Criteria
- •Previous diagnosis of asthma, other airway obstructive disease, sleep apnea syndrome, interstitial lung disease, chest wall disease or neuromuscular disease.
- •Apnea-hypopnea index \> 10/h
- •Morbid obesity (BMI \> 45 Kg/m2)
- •Previous diagnosis of ischaemic heart disease, cardiac failure, cirrhosis, chronic renal failure, rheumatoid arthritis or other inflammatory disease.
Arms & Interventions
Control
Conventional treatment for COPD
Intervention: Control
NIMV group
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Intervention: NIMV group
Outcomes
Primary Outcomes
daily physical activity and plasmatic concentration of C-reactive protein
Time Frame: 12 months
Secondary Outcomes
- Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane(12 months)
- PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD(12 months)
- Adverse effects(12 months)
- Cardiovascular effects, exacerbations, hospitalizations and mortality(12 months)
- BDI/TDI, SF-36, SGRQ, LCADL(12 months)