Treatment of chronic Respiratory failure in COPD patients with non-invasive ventilation: starting at home and selecting the right patient
Phase 3
Completed
- Conditions
- Lung emphysema10006436
- Registration Number
- NL-OMON43384
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
Inclusion Criteria
- Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ FVC< 70% and FEV1< 50% predicted; PaCO2 > 6.0 kPa in stable condition, which means no COPD exacerbation for 4 weeks and a pH > 7.35)
- Age > 18 years
- Existence of a sufficient social support network making initiation of HMV at home possible and safe.
- Written informed consent is obtained
Exclusion Criteria
- Instable severe cardiac comorbidities (left ventricular ejection fraction below 45%, instable angina pectoris complaints)
- Patients admitted to a nursing home
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Non-inferiority of home initiation of NIV will be assesed in terms of<br /><br>improvement in PaCO2 (at daytime without NIV or additional oxygen) after 6<br /><br>months. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are change in lung function (forced expiratory volume in 1<br /><br>second (FEV1), lung volumes (total lung capacity (TLC), residual volume (RV)<br /><br>and RV%TLC), and diffusion capacity (DLCO (%predicted)), change in HRQoL,<br /><br>compliance, exercise tolerance and costs including cost-effectiveness analyses</p><br>