octurnal Non-Invasive ventilation in COPD patients with stable hypercapnic respiratory failure: why and in which patient might this be effective?

Phase 4

Recruiting

Conditions: COPD
chronic obstructive pulmonary disease
10038716

Registration Number: NL-OMON48829

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 86

Inclusion Criteria

• Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC)< 70% and FEV1< 50% predicted; PaCO2 > 6.0 kilopascal (kPa) in stable condition, which means no COPD exacerbation for 4 weeks and a pH > 7.35)
• Shared consent of the participant and agreement of the participant and his/her home mechanical ventilation centre doctor to start NIV
• Age > 18 years
• Written informed consent is obtained

Exclusion Criteria

For inclusion in the prospective cohort part of the study no special exclusion criteria exist. ;For the randomised inflammation part, in which patients will undergo bronchoscopies, a potential subject who meets any of the following criteria will be excluded from participation in this study:;• The use of >10mg oral corticosteroids or roflumilast in any dosage
• A history of lung volume reduction surgery
• Body mass index (BMI) > 35 kg/m2
• Obstructive sleep apnoea (OSA) (apnoea/hypopnea index (AHI) >15/hr): to exclude OSA a polygraphy will be done at baseline
• PaCO2 >= 8.0 kPa or PaO2 < 6.5 kPa at rest without oxygen
• Instable cardiac comorbidities (left ventricular ejection fraction (LVEF)<40%, instable coronary artery disease, instable heart failure)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The main endpoint is the change FEV1 after 3<br /><br>months. Furthermore, as we recognise that FEV1 might not be the most important<br /><br>patient-related outcome, we will assess which parameters affect health-related<br /><br>quality of life after 3 and 6 months.</p><br>

Secondary Outcome Measures