OPEN Research Support

Bente Grøn
Department of Medicine, Vejle Hospital

Projekt styring
Projekt status    Open
Data indsamlingsdatoer
Start 01.07.2023  
Slut 30.06.2025  

Open-Label Prospective Study Comparing Long-Term Outcome with or without High-flow Nasal Cannula AirvoTM (HFNC) in Patients with Stable COPD and chronic respiratory failure

Short summary

The study's theory is that ventilation treatment via the nasal catheter (AirvoTM) can be a good alternative to COPD patients who do not tolerate NIV via mask. At the same time, it is expected that the treatment can reduce the elevated carbon dioxide content in the blood, reduce the number of acute exacerbations and improve the quality of life when compared with the previous 12 months on standard treatment. The total duration of the study will be 12 months.


Studies show that non-invasive ventilation (NIV) via mask can reduce mortality and increase quality of life in COPD patients with elevated (CO2) in the blood (hypercapnia), but not all patients tolerate this treatment. Instead, preliminary studies show that ventilation treatment via nasal catheters can help this patient group. This intervention study aims to investigate the long-term effect of treatment with the nasal catheter "High Flow Nasal Cannula" (Airvo™) for patients with COPD who have elevated carbon dioxide levels in the blood. We hypothesize that HFNC treatment with AirvoTM device 1) improves daytime capillary pCO2 ≥ 0,5 kPa, 2) decreases acute exacerbation rate of COPD, and 3) improves quality of life (QOL) compared to the previous 12 months and to standard treatment.

Description of the cohort

The patients are recruited from three hospitals in Denmark in connection with the patients' discharge from wards, where they have been hospitalized due to a worsening of their COPD. Patients meeting the inclusion criteria and show interest, receive oral information about the study and written information is provided before the discharge. They are invited to a randomisation visit 3 weeks later. Inclusioncriterias: 1) with at least two acute moderate or severe exacerbations during past 12 months, 2) who at the follow-up visit 2-3 weeks after an acute severe exacerbation of show chronic respiratory failure with a) capillary pCO2 > 6.0 kPa, increased HCO3 and BE or b) normal pCO2, HCO3 > 28 mmol/L and BE > 3 mmol/L. They will be randomized to either standard care or AirvoTM care group via REDCap™ system. The total duration of the study will be 12 months

Data and biological material

Comorbidities, medications (ATC codes with three digits), oxygen use (LTOT, L/min), smoking status, number of acute moderate or severe exacerbations one year prior baseline or within last four weeks prior visits 8 and 15 will be recorded. Height, weight, BMI, spirometry with bronchodilator, capillary blood gases, hemoglobin, leucocyte count including differential cell count, and serum C-reactive protein (CRP) will be measured. Improvement on St. George's Respiratory Questionnaire, mMRC, CAT, SRI, EQ5D, and 6MWT.

Collaborating researchers and departments

Department of Pulmonary Diseases, Esbjerg Hospital

    Department of Pulmonary Diseases, Gødstrup Hospital ( Former Holstebro)