COPD COPD
Conditions
Interventions
NIV or spontaneous breathing
Sponsors
Maastricht Universitair Medisch Centrum +
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of COPD GOLD III/IV.Diagnosis of chronic hypercapnic respiratory failure or chronic combined respiratory failure.Established use of NIV.Use of a nose and mouth covering maskAdults with the mental and physical ability to understand the purpose and procedures of the study and comply with study requirements.Legal capacity to consent and provision of written informed consent
Exclusion criteria
Exclusion criteria: Presence of a competing cause for hypercapnic respiratory failure.Body mass index (BMI) > 34.Supplementary oxygen with a flow rate > 4 L / min> 12 h of NIV use during 1 day (24 hours)Glomerular filtration rate (GFR) < 30 ml/min.Pregnancy or breastfeeding. Women of childbearing potential must use adequate contraception during the study.Any pre-existing or concomitant disease or condition that, in the investigator’s opinion, poses an unacceptable risk for study participation.Participation in another clinical study involving investigational products within the last 30 days.Anticipated lack of compliance with study procedures.History of alcohol or drug abuse.Institutionalization due to legal or court orders.Employment or dependency relationship with the Coordinating Investigator (Coord. Inv.), Principal Investigator (PI), or their representatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the carbon dioxide elimination (VCO2) during NIV, compared to VCO2 during spontaneous breathing | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters include oxygen uptake (VO2), respiratory quotient (RQ), minute volume (MV), tidal volume (VT) and respiratory rate (RR). | — |
Countries
Netherlands
Contacts
Public ContactN. Cobben
Maastricht Universitair Medisch Centrum +
Outcome results
None listed