High-flow nasal cannula versus home mechanical ventilation for COPD patients with persistent high carbon dioxide after an exacerbation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.