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

Not Applicable

Recruiting

• Conditions: COPD; J44.9; Chronic obstructive pulmonary disease, unspecified

• Registration Number: DRKS00012325
• Lead Sponsor: Forschungszentrum Borstel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

1. Age >40 years
2. COPD diagnosis known for at least 12 months
3. 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distance of the 6 minute walk test at 3 months

Secondary Outcome Measures

Name	Time	Method
At 3 months therapy: NIV parameters (IPAP, PEEP), blood gas analysis (pCO2), number of hospital admissions