SuspendedNo phase
Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD
Key facts
- Who runs it
- Research Center Borstel
- Where
- Germany5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Suspended
- People taking part
- 270 people, planned
- Started
- 1 Nov 2017
- Expected to end
- 1 Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Pursed lip breathing ventilation
- Standard non-invasive ventilation
- Record updated
- 12 April 2024
- Why it stopped
- Devices not available at the moment.
Who can take part
- Age
- 40 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Signed informed consent
- Age >40 years
- COPD diagnosis known for at least 12 months
- NIV therapy for at least 3 months
- 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
Who cannot take part
- Steroid therapy with >15 mg prednisolon daily for >1 month
- Previous therapy with the Vigaro NIV device
- Other leading pulmonary illness
- Condition causing hypercapnia other than COPD
- Current COPD exacerbation (is allowed 4 weeks after end of treatment)
- Radiologically proven pneumonia within the past month
- Tracheostomy
- Pneumothorax
- Pregnancy or lactation
- BMI >35 kg/m²
- 6MWT distance of >300 meters within the last 7 days
- Weight loss of more than 5 kg / 12 months
- Further criteria to exclude confounding factors
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing ventilation (PLBV) ventilation in advanced COPD
The 2 groups in the trial
- InterventionTreatment being tested
Non-invasive ventilation with pursed lip breathing ventilation device
Treatment: Pursed lip breathing ventilation
- ControlExisting treatment, for comparison
Non-invasive ventilation with standard non-invasive ventilation device
Treatment: Standard non-invasive ventilation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 April 2024