Actively Recruiting

Age: 18Years +
All Genders
NCT07414108

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-02-17

25

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of COPD with hypercapnia, defined as PaCO2 greater than 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring mechanical ventilation
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Progressive neurodegenerative diseases
  • Diaphragmatic disorders
  • Severe hemodynamic instability requiring more than one vasoactive agent for at least 24 hours
  • Acute coronary syndrome such as unstable angina or myocardial infarction
  • Severe arrhythmias
  • Contraindications to non-invasive ventilation
  • Cognitive impairment interfering with treatment adherence
  • Active and unstable coronary artery disease
  • Malignancies undergoing active treatment
  • Already receiving home non-invasive mechanical ventilation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

L

Lara Pisani, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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