Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD

Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD

Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD

Intervention:

Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV) with static positive pressures Duration of intervention per patient 3 months as randomized (1:1) followed by 9 months as chosen by patient

Inclusion Criteria:

1. Signed informed consent
2. Age >40 years
3. COPD diagnosis known for at least 12 months
4. NIV therapy for at least 3 months

4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7. Patient is able to follow the study protocol

Exclusion Criteria:

1. Current COPD exacerbation (is allowed 4 weeks after end of treatment)
2. Radiologically proven pneumonia within the past month
3. Other leading pulmonary illness
4. Tracheostomy
5. Pneumothorax
6. Pregnancy or lactation
7. BMI >35 kg/m²
8. Steroid therapy with >15 mg prednisolon daily for >1 month
9. Condition causing hypercapnia other than COPD
10. 6MWT distance of >300 meters within the last 7 days
11. Previous therapy with the Vigaro NIV device
12. Weight loss of more than 5 kg / 12 months
13. Further criteria to exclude confounding factors