How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients
Recruiting · NCT07414108 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
View the official record on ClinicalTrials.gov →What this trial is about
The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. The study population consists of patients with COPD and hypercapnia requiring NIV. The primary objective of the study is to evaluate the association between the reduction in partial pressure of carbon dioxide in arterial blood (PaCO₂) levels at 6 and 12 months after initiating non-invasive ventilation (NIV) and the presence of nocturnal hypoventilation detected at baseline in patients with COPD and chronic hypercapnia. Secondary objectives of this study are the evaluation of the following parameters measured at baseline and/or after 6 and 12 months of NIV treatment in patients with COPD and chronic hypercapnia: * Magnitude of esophageal pressure swing during nocturnal monitoring. * Diaphragm thickness and diaphragmatic thickening fraction assessed by thoracic ultrasound. * Presence of overlap syndrome (COPD + OSA). * Radiological classification of COPD subtypes to assess the association between radiological findings, functional profile, severity of nocturnal hypoventilation, and patterns of chronic hypercapnia. * Respiratory functional parameters, including FEV₁, FVC, FEV₁/FVC ratio, carbon monoxide diffusion capacity (DLCO), and airway resistance (R5 and R20). * Frequency of severe exacerbations and subsequent rehospitalizations during follow-up. * Rate of compliance with respiratory treatment.
Who can take part
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 it is running
1 location listed.
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Bologna, Italy