Asthma, COPD, Pulmonary Fibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMultiple-Breath-Washout
One additional diagnostic test is performed using the Multiple-Breath-Washout technology
Sponsors
Boehringer Ingelheim
ndd Medizintechnik AG
Wissenschaftliches Institut Bethanien e.V
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * existing consent * confirmed diagnosis of one of the following diseases * idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines * chronic obstructive pulmonary disease (COPD) with/without emphysema * bronchial asthma * or patients who are admitted with suspected cardiopulmonary dysfunction (e.g. with unclear dyspnoea) and in whom there is no evidence of cardiopulmonary dysfunction during the diagnostic process (comparison group of healthy patients). * Indication for routine performance of the following pulmonary function tests during the current inpatient stay: Whole Body Plethysmography & Diffusion Capacity of the Lung (single-breath)
Exclusion criteria
* Age \< 18 years * Simultaneous presence of at least two of the following diseases (IPF, COPD/emphysema, asthma, pulmonary arterial hypertension) * any medical, psychological or other condition that restricts the patient's ability to give informed consent for voluntary participation in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Clearance Index | immediately ofter the procedure | comparison of the lung clearance index of the different patient groups |
Countries
Germany
Outcome results
None listed