COPD J44.9
Conditions
Interventions
Group 1: Treatment with pursed lip breathing ventilation NIV for 3 months (Vigaro NIV device)
Group 2: Treatment with standard NIV (Non-invasive Ventilation)
Sponsors
Forschungszentrum Borstel
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >40 years 2. COPD diagnosis known for at least 12 months 3. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distance of the 6 minute walk test at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| At 3 months therapy: NIV parameters (IPAP, PEEP), blood gas analysis (pCO2), number of hospital admissions | — |
Countries
Germany
Contacts
Public ContactVanessa Schümann
Forschungszentrum BorstelKlinisches Studienzentrum
Outcome results
None listed