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OpenTrials
Completed

NCT Number: NCT06179342

Multiple Breath Washout as a Method for Diagnosing Lung Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple-Breath-Washout

Diagnostic Test

One additional diagnostic test is performed using the Multiple-Breath-Washout technology

Primary outcomes

  1. Lung Clearance Index

    Time frame: immediately ofter the procedure

    comparison of the lung clearance index of the different patient groups

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • Boehringer Ingelheim
  • ndd Medizintechnik AG

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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