NCT06179342

Multiple Breath Washout as a Method for Diagnosing Lung Diseases

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Wissenschaftliches Institut Bethanien e.V · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Fibrosis
• COPD
• Asthma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multiple-Breath-Washout	One additional diagnostic test is performed using the Multiple-Breath-Washout technology

Timeline

• Start date: 2021-06-21
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2023-12-21
• Last updated: 2024-05-07

Locations

1 site across 1 country: Germany