Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179342
• Other study ID #: WI_20-1542_1
• Status: Completed
• Start date: June 21, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: May 2024
• Source: Wissenschaftliches Institut Bethanien e.V
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD
• Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• Multiple-Breath-Washout
One additional diagnostic test is performed using the Multiple-Breath-Washout technology

Locations

Country	Name	City	State
Germany	Wissenschaftliches Institut Bethanien e.V.	Solingen	NRW

Sponsors (3)

Lead Sponsor	Collaborator
Wissenschaftliches Institut Bethanien e.V	Boehringer Ingelheim, ndd Medizintechnik AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung Clearance Index	comparison of the lung clearance index of the different patient groups	immediately ofter the procedure