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

NCT07414108 | Recruiting

• 2 other identifiers: HYPONIV2023.0267
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Hypercapnic Respiratory Failure, COPD; COPD; Hypercapnia

Outcome Measures

Primary Outcomes (1)

• The association between the reduction in PaCO₂ levels and the presence of nocturnal hypoventilation

  The primary outcome is measured through arterial blood gas analysis (ABG) to determine PaCO₂ levels, and through transcutaneous monitoring of oxygen saturation and carbon dioxide (SpO₂ and TcCO₂) to assess the presence of nocturnal hypoventilation. Nocturnal hypoventilation is defined as an increase in PaCO₂ during sleep (TcCO₂ \>10 mmHg above daytime PaCO₂ with TcCO₂ \>50 mmHg for at least 10 minutes, or TcCO₂ \>55 mmHg for ≥25% of total sleep time).

  PaCO₂ (mmHg), measured by ABG - baseline, 3, 6, and 12 months TcCO₂ (mmHg), measured by transcutaneous monitoring - baseline

Secondary Outcomes (11)

• Magnitude of esophageal pressure swing during nocturnal monitoring

  Baseline

• Diaphragm thickness and diaphragmatic thickening fraction

  Baseline

• Diaphragmatic thickening fraction

  Baseline

• Presence of overlap syndrome (COPD + OSA)

  Baseline

• Radiological classification of COPD subtypes

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna.

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Related Publications (1)

• Murray I, Paterson E, Thain G, Currie GP. Outcomes following non-invasive ventilation for hypercapnic exacerbations of chronic obstructive pulmonary disease. Thorax. 2011 Sep;66(9):825-6. doi: 10.1136/thx.2010.152264. Epub 2010 Dec 9. PMID: 21148571.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiration Disorders

Central Study Contacts

Lara Pisani, PhD

CONTACT

0512143253; lara.pisani@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: February 17, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2025-12

Locations

IT (1)