Clinical trial NCT06179342: Multiple Breath Washout as a Method for Diagnosing Lung Diseases
Official title: Comparison of New Methods of Multiple Breath Washout and Diffusion Capacity Determination (Ndd Medizintechnik Zurich, Trueflow™/Truecheck™) With Established Methods of Lung Function Diagnostics in Patients With Idiopathic Pulmonary Fibrosis, Chronic Obstructive Pulmonary Disease, Asthma and Cardiopulmonary Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
COPD
Asthma
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: ndd Medizintechnik AG
First posted: 2023-12-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the study center with one of the above-mentioned diseases

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung Clearance Index
timeFrame: immediately ofter the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Solingen
country: Germany
facility: Wissenschaftliches Institut Bethanien e.V.
state: NRW
Study officials:
affiliation: Wissenschaftliches Institut Bethanien e.V
name: Lars Hagmeyer, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: