Multiple Breath Washout as a Method for Diagnosing Lung Diseases

NCT ID: NCT06179342

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2024-03-01

Brief Summary

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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

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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

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Pulmonary Fibrosis COPD Asthma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiopulmonary healthy

Patients in whom there is no evidence of cardiopulmonary dysfunction in the course of diagnostics

Multiple-Breath-Washout

Intervention Type DIAGNOSTIC_TEST

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

Idiopathic pulmonary fibrosis

idiopathic pulmonary fibrosis (IPF), confirmed according to the guidelines

Multiple-Breath-Washout

Intervention Type DIAGNOSTIC_TEST

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

Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) with/without emphysema

Multiple-Breath-Washout

Intervention Type DIAGNOSTIC_TEST

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

Asthma bronchiale

Multiple-Breath-Washout

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Multiple-Breath-Washout

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

ndd Medizintechnik AG

INDUSTRY

Sponsor Role collaborator

Wissenschaftliches Institut Bethanien e.V

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Hagmeyer, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Wissenschaftliches Institut Bethanien e.V

Locations

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Wissenschaftliches Institut Bethanien e.V.

Solingen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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WI_20-1542_1

Identifier Type: -

Identifier Source: org_study_id

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