COPD
Conditions
Interventions
The intervention investigated is chronic NIV. NIV will be set as it is in usual
care, supplied through a pressure cycled ventilator (Stellar 100® or Lumis®,
RESMED LtD, Bella Vista NSW 2153, Austral
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced expiratory volume (FVC) 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Exclusively in the randomised airway study • Airway abnormalities, the amount of emphysema and air-trapping assessed with a High Resolution computertomography (HRCT) scanning with in- and expiration. • Airway inflammation and remodelling assessed with bronchial brushes and washes and airway biopsies obtained through bronchoscopy All participants • Change in HRQoL assessed by the severe respiratory insufficiency questionnaire summary score (SRI) • Safety: the number of adverse events will be recorded. • Additional assessment of generic and disease specific aspects of HRQoL, evaluated with the SF-36 and the CCQ. • Anxiety and depression, evaluated by the hospital anxiety and depression scale (HADS). • Activities and Restrictions, assessed with the Groningen Activity and Restriction Scale (GARS) • Caregiver Burden, assessed with the Caregiver Strain Index (CSI) • Dyspnoea, using the Medical Research Council (MRC) score. • Gas exchange at daytime without additional oxygen assessed with an arterial blood gas analysis • Gas exchange during the night assessed with transcutaneous CO2 measurements. • Respiratory muscle activity and patient-ventilator asynchrony during the night and during NIV assessed with surface electromyography (EMG) • Lung function • Exercise tolerance assessed by the 6-minute walking distance. • Peripheral muscle function: quadriceps muscle strength will be assessed with the 1-repitition maximum test • Compliance with the ventilator • Blood DNA, biomarkers of inflammation, and biomarkers of response: 5 venous samples will be obtained by one venapunction: 1 for hematology (leucocytes count), 1 for chemistry (NT-proBNP, uric acid), 1 for fibrinogen, 1 for the interleukins, 1 for DNA • Urine sample to asses urine albumin to creatinine ratio • Nasal epithelium markers of remodelling and repair, obtained with a nasal brush | — |
Countries
Netherlands
Outcome results
None listed