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| ID | Type | Description | Link |
|---|---|---|---|
| 2023.0267 | Other Grant/Funding Number | Fondazione Cassa di Risparmio Bologna |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
| Diaphragm thickness and diaphragmatic thickening fraction |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lara Pisani, PhD | Contact | 0512143253 | lara.pisani@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21148571 | Background | 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. No abstract available. |
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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 |
| 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. | Baseline |
| Presence of overlap syndrome (COPD + OSA) | Overnight cardiorespiratory monitoring | 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). | Baseline |
| Respiratory functional parameters | FEV₁, FVC, FEV₁/FVC ratio measured by spirometry. Unity of measure: L | Baseline, 6 and 12 months |
| Respiratory functional parameters | DLCO | Baseline, 6 and 12 months |
| Respiratory functional parameters | Resistance at 5 Hz (R5) and Resistance at 20 Hz (R20) | Baseline, 6 and 12 months |
| Respiratory functional parameters | 6 Minutes Walking Test (6MWT) | 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. | 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. | baseline, 6 and 12 months |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
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