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

Recruitingn/aAges 18 Years - anyAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT07414108 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 esophag

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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