Status:
SUSPENDED
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
Lead Sponsor:
Research Center Borstel
Conditions:
COPD
Eligibility:
All Genders
40+ years
Phase:
NA
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 stat...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age \>40 years
- COPD diagnosis known for at least 12 months
- 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
- Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- Radiologically proven pneumonia within the past month
- Other leading pulmonary illness
- Tracheostomy
- Pneumothorax
- Pregnancy or lactation
- BMI \>35 kg/m²
- Steroid therapy with \>15 mg prednisolon daily for \>1 month
- Condition causing hypercapnia other than COPD
- 6MWT distance of \>300 meters within the last 7 days
- Previous therapy with the Vigaro NIV device
- Weight loss of more than 5 kg / 12 months
- Further criteria to exclude confounding factors
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03299764
Start Date
November 1 2017
End Date
July 1 2027
Last Update
April 12 2024
Active Locations (5)
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1
Thoraxklinik Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69126
2
Waldburg-Zeil Kliniken - Fachkliniken Wangen
Wangen, Baden-Wurttemberg, Germany, 88239
3
Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845
4
LungenClinic Großhansdorf
Großhansdorf, Schleswig-Holstein, Germany, 22937