How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients

Recruiting now

Conditions studied: COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia, Hypercapnic Respiratory Failure, COPD

In brief

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.

Key facts

Study ID: NCT07414108
Run by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
People needed: 25
Starts: 2025-12-10
Expected to finish: 2028-06-01
Last updated by the study team: 2026-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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