NL-OMON48829
Recruiting
Phase 4
octurnal Non-Invasive ventilation in COPD patients with stable hypercapnic respiratory failure: why and in which patient might this be effective? - The effects of nocturnal non-invasive ventilation in stable COPD patients
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 86
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
The Effects of Nocturnal Non-invasive Ventilation in Stable COPDNoninvasive VentilationNCT03053973Peter Wijkstra116
Terminated
Not Applicable
Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)Chronic Obstructive Pulmonary DiseaseHypercapniaNCT00710541Deutsche Lungenstiftung e.V.195
Completed
Not Applicable
Trial of Non-invasive Ventilation for Stable COPDCOPDNCT01722773University of Iowa40
Completed
Not Applicable
Deventilation Dyspnea in COPD Patients Using NIVCOPDDyspneaMechanical Ventilation ComplicationNCT03503123University Medical Center Groningen10
Completed
Not Applicable
Initiation of Long-term Non-invasive Ventilation in COPDChronic Obstructive Pulmonary DiseaseNCT02652559University Medical Center Groningen67