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

Research Center Borstel

Status: Suspended

Conditions: COPD

Treatments: Device: Pursed lip breathing ventilation; Device: Standard non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03299764

DZL PBLV Trial

Details and patient eligibility

About

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

Full description

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

Enrollment: 270 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

5. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Intervention

Experimental group

Description:

Non-invasive ventilation with pursed lip breathing ventilation device

Treatment:

Device: Pursed lip breathing ventilation

Control

Active Comparator group

Description:

Non-invasive ventilation with standard non-invasive ventilation device

Treatment:

Device: Standard non-invasive ventilation