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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
| ndd Medizintechnik AG | INDUSTRY |
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Comparison of the new multiple-breath washout method (ndd Medizintechnik Zürich, Trueflow™/Truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.
This diagnostic, prospective, clinical study aims to investigate whether the lung function data measured with the EasyOnePro®LAB device correlates with the lung function data from established measurement methods used in routine clinical practice. It is to be investigated whether the EasyOnePro®LAB measurement leads to equivalent results even with a shorter measurement duration due to an improved evaluation. This is relevant for a broader clinical application in the future.
It will also be tested whether the fact that the EasyOnePro®LAB measurement can be carried out largely independently of the employee also leads to better reproducibility of the results. To this end, the intra-individual deviations in repeated measurements will be compared between the methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiopulmonary healthy | Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics |
| |
| Idiopathic pulmonary fibrosis | idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines |
| |
| Chronic obstructive pulmonary disease | Chronic obstructive pulmonary disease (COPD) with/without emphysema |
| |
| Asthma bronchiale |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple-Breath-Washout | Diagnostic Test | One additional diagnostic test is performed using the Multiple-Breath-Washout technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung Clearance Index | comparison of the lung clearance index of the different patient groups | immediately ofter the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted to the study center with one of the above-mentioned diseases
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| Name | Affiliation | Role |
|---|---|---|
| Lars Hagmeyer, PD Dr. | Wissenschaftliches Institut Bethanien e.V | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wissenschaftliches Institut Bethanien e.V. | Solingen | North Rhine-Westphalia | 42699 | Germany |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |