Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics
NCT ID: NCT04531293
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
128 participants
INTERVENTIONAL
2020-12-31
2022-04-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Spirometry, lung volume measurement by body plethysmography and DLCO measurements will be performed on reference device (Masterscreen Body/Diff, Vyaire, USA), Spirometry and DLCO will also be performed on the device under test (EasyOne Pro LAB, ndd Medizintechnik AG, Switzerland) in a crossover design. Both devices are CE marked and FDA approved. The tests performed on both devices are standardized tests performed routinely with patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multiple Breath Washout as a Method for Diagnosing Lung Diseases
NCT06179342
Pulmonary Diffusing Capacity During Acute Exercise in Patients With COPD
NCT05583396
Change in Airway Peripheral Tone in COPD
NCT04166812
Monitoring Chronic Obstructive Pulmonary Disease Patients at Home by a Forced Oscillation Technique Device
NCT01552031
Continuous Monitoring of Patients With Chronic Obstructive Pulmonary Disease
NCT01741935
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Total-breath method followed by standard method
Total Lung Capacity (TLC) measurement performed on device EasyOne Pro (TM) according to total-breath method followed by TLC measurement performed on device MasterScreen (TM) according to standard method.
Respiratory Analysis System
Measurement of total lung capacity using total-breath method
Respiratory Analysis System
Measurement of total lung capacity using standard method
Standard method followed by total breath method
Total Lung Capacity (TLC) measurement performed on device Masterscreen (TM) according to standard method followed by TLC measurement performed on device EasyOne Pro (TM) according to total-breath method.
Respiratory Analysis System
Measurement of total lung capacity using total-breath method
Respiratory Analysis System
Measurement of total lung capacity using standard method
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Respiratory Analysis System
Measurement of total lung capacity using total-breath method
Respiratory Analysis System
Measurement of total lung capacity using standard method
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy subjects, FEV1/FEV1(pred) \> 80%
* COPD GOLD classification 1 or 2, FEV1/FEV1(pred) ≥ 50%
* COPD GOLD classification 3 or 4, FEV1/FEV1(pred) \< 50%
Exclusion Criteria
* BMI \> 30
* Any relevant concomitant diseases (investigators decision)
* Any relevant concomitant medication (investigators decision)
* FEV1/FEV1(pred) \<= 80%
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ndd Medizintechnik AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LungenZentrum Hirslanden
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Jorres RA, Buess C, Piecyk A, Thompson B, Stanojevic S, Magnussen H. The total-breath method yields higher values of DLCO and TLC than the conventional method. BMC Pulm Med. 2024 Mar 13;24(1):127. doi: 10.1186/s12890-024-02932-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EOP17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.