Status:
TERMINATED
Open-Label Prospective Study Comparing Long-Term Outcome With or Without HFNC in Patients With Stable Hypercapnic COPD
Lead Sponsor:
Turku University Hospital
Conditions:
COPD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aims of the study are to compare long-term one-year outcome with or without AirvoTM in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD.
Detailed Description
When compared to NIV, much less experience is available from clinical studies on HFNC therapy. Until now, few studies have investigated the effect of HFNC therapy on hypercapnic COPD patients and the ...
Eligibility Criteria
Inclusion
- COPD patients 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit one month after an acute severe exacerbation of COPD are hypercapnic (capillary pCO2 \>6.5 kPa) and not willing to use NIV or have used it less than 4 h/d during the last month despite optimal settings prescribed by an experienced pulmonologist, or if a patient at the follow-up one month after a severe exacerbation is hypercapnic and is willing to try NIV (initiated at the follow-up visit, not at the ward), but then uses it less than 4h/d during the following month. Acute moderate (treated with short acting bronchodilators plus antibiotics and/or oral corticosteroids) and severe (patient requires hospitalization or visits the emergency room) exacerbations of COPD are defined according to the GINA Guidelines (GOLD 2019).
Exclusion
- 1) OSA (diagnosed OSA or high suspicion OSA because of regular snoring, witnessed apneas and daytime sleepiness), 2) neuromuscular or chest wall disease, 3) BMI\>35 kg/m2 or 4) a patient is not able to give his/her informed consent for the study.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04840706
Start Date
April 21 2022
End Date
April 30 2024
Last Update
December 29 2025
Active Locations (1)
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1
Turku University Hospital
Turku, Finland, 20521