NCT07414108 How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients
| NCT ID | NCT07414108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | COPD |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2025-12-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07414108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07414108 currently recruiting?
Yes, NCT07414108 is actively recruiting participants. Contact the research team at lara.pisani@unibo.it for enrollment information.
Where is the NCT07414108 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT07414108 clinical trial?
NCT07414108 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 25 participants.
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