An observational study in COPD, COPD (Chronic Obstructive Pulmonary Disease) and Hypercapnia, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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:
To date, the pathophysiological mechanisms underlying the development of persistent hypercapnia in patients with COPD are not completely understood. Likewise, reliable predictive markers capable of identifying both patients at risk of developing this condition and those who may derive the greatest benefit from long-term non-invasive ventilation (NIV) are still lacking. Early identification of a patient phenotype more responsive to this type of intervention could substantially reduce exacerbations, emergency department visits, hospitalizations, and associated healthcare costs, thereby improving the overall efficiency of the local healthcare system. The aim of this study is therefore to identify more accurate and earlier criteria to recognize patients with COPD and hypercapnic respiratory failure who may benefit from long-term non-invasive ventilatory support, through an integrated analysis of respiratory mechanics data and clinical and functional parameters commonly used in routine clinical practice.
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. For these patients clinical, functional, and respiratory mechanics data will be collected. Data will be collected at the baseline visit-corresponding to the first visit at the OSAS Ventilated outpatient clinic or the first day of hospitalization in the Pneumology and Respiratory Intensive Care Unit-and during follow-up visits, scheduled according to routine clinical practice at 6 and 12 months after initiation of NIV treatment.
The total duration of the study will be 30 months, including 12 months for patient enrollment, 12 months of follow-up, and 6 months for data analysis.
A total of 25 patients will be included.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 25 is below the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Time frame: PaCO₂ (mmHg), measured by ABG - baseline, 3, 6, and 12 months TcCO₂ (mmHg), measured by transcutaneous monitoring - baseline
Magnitude of esophageal pressure swing during nocturnal monitoring
Placement of a nasogastric respiratory mechanics catheter equipped with an esophageal balloon, and measurement of maximal inspiratory pressure swing (ΔPES).
Time frame: Baseline
Diaphragm thickness and diaphragmatic thickening fraction
Assessment of diaphragm thickness variation (TDi-exp, measured from pleural to peritoneal line at end-expiration; normal \<1.5 mm suggesting diaphragmatic weakness). Unit of measure: mm
Time frame: Baseline
Diaphragmatic thickening fraction
Thickening fraction will be measured with the following formula: TFdi = (inspiratory thickness - expiratory thickness) / expiratory thickness × 100). This outcome will be measure via thoracic ultrasound using a linear probe positioned sagittally along the axillary line at the 8th-9th intercostal space.
Time frame: Baseline
Presence of overlap syndrome (COPD + OSA)
Overnight cardiorespiratory monitoring
Time frame: Baseline
Radiological classification of COPD subtypes
Data collection from High-resolution computed tomography (HRCT) for morphological evaluation and structural phenotyping (presence or absence of: emphysema, airway-wall thickening, bronchiectasis, air trapping).
Time frame: Baseline
Respiratory functional parameters
FEV₁, FVC, FEV₁/FVC ratio measured by spirometry. Unity of measure: L
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
DLCO
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
Resistance at 5 Hz (R5) and Resistance at 20 Hz (R20)
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
6 Minutes Walking Test (6MWT)
Time frame: Baseline, 6 and 12 months
Frequency of severe exacerbations
number of hospital admissions, ICU admissions, high-dependency unit admissions, and episodes of acute hypercapnic respiratory failure (AHRF) throughout the study period.
Time frame: baseline, 6 and 12 months
Compliance with respiratory treatment
number of nights where the respiratory support has been used for at least 4 hours/night divided by the total number of nights during treatment.
Time frame: baseline, 6 and 12 months
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