High-flow nasal cannula versus home mechanical ventilation for COPD patients with persistent high carbon dioxide after an exacerbation
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study
This study tests whether using high-flow nasal cannula plus standard oxygen can lower CO2 as well as home mechanical ventilation plus standard oxygen in people with COPD who still have high CO2 after a severe flare.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 5 sites (Arezzo and 4 other locations) |
| Trial ID | NCT07065799 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized crossover trial enrolls patients with COPD and persistent hypercapnia after a severe exacerbation and compares two home respiratory supports: high‑flow nasal cannula (NHF) plus standard oxygen and home mechanical ventilation (HMV) plus standard oxygen. Each participant receives both treatments for three months in randomized order with a seven‑day washout, so each patient serves as their own control. The primary outcome is change in arterial PaCO2 to test non‑inferiority of NHF versus HMV. Secondary outcomes include safety, tolerability, and clinical events over the total 25‑week treatment period.
Who should consider this trial
Good fit: Adults with COPD who remain hypercapnic (PaCO2 >53 mmHg) 2–4 weeks after a hypercapnic exacerbation requiring noninvasive ventilation, with pH >7.35 and chronic hypoxemia meeting the protocol thresholds, are the intended participants.
Not a fit: Patients with BMI >30 kg/m2, clinically significant obstructive sleep apnea, neuromuscular or chest wall disease, those already on home NIV/CPAP, or those who required intubation during the exacerbation are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the study could provide a simpler, better‑tolerated home breathing option that lowers CO2 similarly to home mechanical ventilation.
How similar studies have performed: Home mechanical ventilation is an established treatment for chronic hypercapnia, while high‑flow nasal cannula has shown promising PaCO2 reductions in smaller studies, but direct non‑inferiority comparisons versus HMV are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arezzo and 4 other locations
- Ospedale S Donato — Arezzo, Italy (Recruiting)
- Bolzano Hospital — Bolzano, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco" — Catania, Italy (Recruiting)
- ICS Maugeri Spa Società Benefit IRCCS — Pavia, Italy (Recruiting)
- Azienda Unità Sanitaria Locale — Piacenza, Italy (Recruiting)
Study contacts
- Principal investigator: Lara Pisani, Prof.ssa — University of Bologna
- Study coordinator: Lara Pisani, Prof.ssa
- Email: lara.pisani@unibo.it
- Phone: 0512143257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.