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

Not Applicable

Suspended

• Conditions: COPD
• Interventions: Device: Pursed lip breathing ventilation; Device: Standard non-invasive ventilation

• Registration Number: NCT03299764
• Lead Sponsor: Research Center Borstel

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-10-03
• Study Start: 2017-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2026-11-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pursed lip breathing ventilation	Non-invasive ventilation with pursed lip breathing ventilation device
Control	Standard non-invasive ventilation	Non-invasive ventilation with standard non-invasive ventilation device

Primary Outcome Measures

Name	Time	Method
Walking distance in 6-minutes walking test	3 months

Secondary Outcome Measures

Name	Time	Method
Number of hospital admissions	12 months
Mortality	12 months

Trial Locations

Locations (5)

Waldburg-Zeil Kliniken - Fachkliniken Wangen; 🇩🇪 Wangen, Baden-Württemberg, Germany

Research Center Borstel; 🇩🇪 Borstel, Schleswig-Holstein, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

LungenClinic Großhansdorf; 🇩🇪 Großhansdorf, Schleswig-Holstein, Germany

Thoraxklinik Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany