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In this multicenter study the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for Ventilation/ Perfusion (V/Q) matching) with functional respiratory imaging (FRI) and arterial blood gas (ABG) values will be evaluated in hypercapnic Chronic Obstructive Pulmonary Disease (COPD) patients. Therefore a low dose Computed Tomography (CT) scan will be taken in a population of 30 patients with non-invasive ventilation (NIV) and in a control group of 10 patients without NIV. The CT-scan will be used for FRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive ventilation (NIV) | Active Comparator | 30 patients will receive NIV during 6 months = group 1 |
|
| Control group | Placebo Comparator | 10 patients will act as control group, they will not be treated with NIV = group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Respiratory Imaging | Radiation | CT-scan of thorax. At baseline, after 1 month and after 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the distribution of the mass flow per lobe and the relative proportion of bloodvessels, as obtained from functional respiratory imaging (FRI) and arterial blood gas (ABG). | The primary objective of this study is the comparison of the mass flow distribution and redistribution versus the relative blood flow per lobe (as a surrogate for V/Q matching) with FRI and ABG values in hypercapnic COPD patients treated with long-term NIV. | At baseline, after 1 month and after 6 months of treatment with non-invasive ventilation (NIV) |
| Measure | Description | Time Frame |
|---|---|---|
| Health related quality of life | Saint George's Respiratory Questionnaire (SGRQ) and Severe Respiratory Insufficiency (SRI) Questionnaire | At baseline, after 1 month and after 6 months |
| Lung function tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried De Backer, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Peter Wijkstra, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium | ||
| University Medical Center Groningen |
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| Lung compliance measurement | Other | At baseline |
|
| Non-invasive ventilation (Respironics) | Device | Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 > 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion. |
|
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Spirometry, reversibility, plethysmography, diffusion, Maximal Inspiratory Pressure (MIP), Maximal Expiratory Pressure (MEP)
| At baseline, after 1 month and after 6 months |
| Hospital admissions | Length and frequency of admission, severity of exacerbations, ICU admissions | After 1 month and after 6 months |
| Exercise tolerance | 6 minutes walking test and oximetry measurement | At baseline, after 1 month and after 6 months |
| Local airway volume and resistance | CT-scan of thorax. CT scan is performed with a low radiation protocol. These images are made to perform computational fluid dynamics on in order to obtain more information on regional lung function characteristics. | At baseline, after 1 month and after 6 months |
| Prediction of breathing pattern | The tertiary objective of the study is to predict the breathing pattern (including tidal volume) during NIV when using the data of patient specific lobar compliance and regional resistance at baseline. | At baseline |
| Groningen |
| 9700 |
| Netherlands |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006935 | Hypercapnia |
| 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 |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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