Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to help people with COPD (a lung condition) who have high levels of carbon dioxide in their blood after a serious flare-up of their illness. Researchers want to see if using a high flow nasal cannula (a device that delivers oxygen through the nose) works just as well as home mechanical ventilation (a machine that helps with breathing at home) when both are combined with standard oxygen therapy. The main goal is to find out which method better lowers the carbon dioxide levels in the blood.

People eligible for this study are adults with COPD who still have high carbon dioxide levels 2 to 4 weeks after a severe flare-up that needed breathing support, but whose blood acidity is stable. They also must have low oxygen levels in their blood and meet other health criteria. Participants will be randomly assigned to start with one of the two treatments, then switch to the other after three months, so everyone tries both methods. The study is currently recruiting and includes men and women aged 18 and older. If you join, you will receive close monitoring and support throughout the study to see which breathing support works best for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Acquisition of informed consent form
• • Patients with COPD
• • Persistent hypercapnia (PaCO2 \>53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring NIV.
• • pH value \>7.35.
• • Chronic hypoxemia (PaO2 \<55mmHg or \<60mmHg if at least one of the following criteria is present: polycythemia, pulmonary hypertension or Chronic Pulmonary Heart Disease, \>30% of sleep time with SpO2 \< 90% measured with a pulse oximeter)
• Exclusion Criteria:
• • BMI \>30 kg/m2
• • Clinically significant obstructive sleep apnea syndrome (patients in whom there was a clinical suspicion of OSA syndrome based on clinical review or overnight oximetry will go further testing with limited respiratory polygraphy)
• • Neuromuscular or chest wall diseases
• • Need for intubation and invasive mechanical ventilation during exacerbation
• • Use of home non-invasive mechanical ventilation or CPAP
• • Contraindications for NIV
• • Presence of cognitive impairment that would prevent informed consent into the trial
• • Patients with active and unstable coronary artery syndrome
• • Patients suffering from malignancies