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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2027-07-01

Brief Summary

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

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Detailed Description

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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

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Non-invasive ventilation with pursed lip breathing ventilation device

Group Type EXPERIMENTAL

Pursed lip breathing ventilation

Intervention Type DEVICE

A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.

Control

Non-invasive ventilation with standard non-invasive ventilation device

Group Type ACTIVE_COMPARATOR

Standard non-invasive ventilation

Intervention Type DEVICE

Standard non-invasive ventilation

Interventions

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Pursed lip breathing ventilation

A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.

Intervention Type DEVICE

Standard non-invasive ventilation

Intervention Type DEVICE

Eligibility Criteria

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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

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

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No