Status:

COMPLETED

Multiple Breath Washout as a Method for Diagnosing Lung Diseases

Lead Sponsor:

Wissenschaftliches Institut Bethanien e.V

Collaborating Sponsors:

Boehringer Ingelheim

ndd Medizintechnik AG

Conditions:

Pulmonary Fibrosis

COPD

Eligibility:

All Genders

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 fibro...

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 measurem...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 21 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2024

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT06179342

Start Date

June 21 2021

End Date

March 1 2024

Last Update

May 7 2024

Active Locations (1)

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Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, Germany, 42699