Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Completed

• Conditions: Pulmonary Fibrosis; COPD; Asthma
• Interventions: Diagnostic Test: Multiple-Breath-Washout

• Registration Number: NCT06179342
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

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.

Study Timeline

• Study Start: 2021-06-21
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2023-12-21
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Asthma bronchiale	Multiple-Breath-Washout	-
Cardiopulmonary healthy	Multiple-Breath-Washout	Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics
Idiopathic pulmonary fibrosis	Multiple-Breath-Washout	idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines
Chronic obstructive pulmonary disease	Multiple-Breath-Washout	Chronic obstructive pulmonary disease (COPD) with/without emphysema

Primary Outcome Measures

Name	Time	Method
Lung Clearance Index	immediately ofter the procedure	comparison of the lung clearance index of the different patient groups

Trial Locations

Locations (1)

Wissenschaftliches Institut Bethanien e.V.; 🇩🇪 Solingen, NRW, Germany