Does nighttime hypoventilation predict long-term benefit from non-invasive ventilation in people with hypercapnic COPD?
Role of Nocturnal Hypoventilation in Predicting the Long-Term Ventilatory Response in Hypercapnic COPD Patients Treated With Non-Invasive Ventilation: A Prospective Observational Study With Clinical, Functional, and Radiological Assessment
This project tests whether nighttime hypoventilation can identify people with COPD and high CO2 who will have larger drops in arterial CO2 after 6 and 12 months on non-invasive ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07414108 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational cohort enrolling adults with COPD and chronic hypercapnia who start non-invasive ventilation at the Respiratory and Critical Care Unit of IRCCS AOU Bologna. Baseline overnight respiratory mechanics (including nocturnal hypoventilation and esophageal pressure swings), diaphragm thickness, and routine clinical and functional measures will be recorded. Participants will be followed at 6 and 12 months to measure changes in arterial PaCO2 and other clinical and functional outcomes. The goal is to identify baseline markers that predict sustained PaCO2 reduction with long-term NIV.
Who should consider this trial
Good fit: Adults (≥18 years) with COPD and chronic or persistent hypercapnia (PaCO2 > 50 mmHg) who require non-invasive ventilation and can attend the IRCCS AOU Bologna clinic or be hospitalized there.
Not a fit: Patients with progressive neurodegenerative disease, diaphragmatic disorders, active unstable cardiac disease, cognitive impairment preventing adherence, contraindications to NIV, or those already on home NIV are unlikely to be appropriate or to benefit from this protocol.
Why it matters
Potential benefit: If successful, clinicians could use nighttime breathing measures to select COPD patients most likely to get sustained CO2 reduction and fewer hospital visits from home NIV.
How similar studies have performed: Previous trials show long-term NIV can lower PaCO2 and reduce exacerbations in chronic hypercapnic COPD, but using baseline nocturnal hypoventilation and esophageal pressure measures as predictors is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patients with COPD and hypercapnia, defined as PaCO₂ \> 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring invasive or non-invasive mechanical ventilation * Provision of informed consent Exclusion Criteria: * Progressive neurodegenerative diseases * Diaphragmatic disorders * Severe hemodynamic instability (\>1 vasoactive agent for at least 24 hours) * Acute coronary syndrome (unstable angina / myocardial infarction) * Severe arrhythmias * Presence of contraindications to NIV * Cognitive impairment interfering with treatment adherence * Active and unstable coronary artery disease * Malignancies undergoing active treatment * Patients already receiving home non-invasive mechanical ventilation
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Lara Pisani, PhD
- Email: lara.pisani@unibo.it
- Phone: 0512143253
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.