LungenZentrum Hirslanden
Zurich, 8032, Switzerland
NCT Number: NCT04531293
Total Lung Capacity (TLC) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a CO diffusing capacity test). The results of the two methods differ, especially in patients with higher grades of COPD. The study investigates an improved analysis for the determination of TLC using the dilution method; this method has been suggested in the new ATS/ERS DLCO (diffusion capacity of lung for carbon monoxide) standard published in 2017. This study is based on approx. 120 participants. So far, there has not been a study using commercially available equipment.
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Zurich, 8032, Switzerland
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
3 groups
Exclusion criteria
Additional exclusion criteria for healthy subjects:
Measurement of total lung capacity using total-breath method
Other names: EasyOne Pro (TM) by ndd Medizintechnik AG
Time frame: single measurement on day 1
Difference in Total Lung Capacity (TLC) using total-breath method (according to ATS/ERS standard 2017, EasyOne Pro) and TLC using normal dilution method (according to ATS/ERS standard 2005, EasyOne Pro) in relation to TLC using body plethysmography (Vyaire).
Time frame: single measurement on day 1
Correlation between ( TLC(dilution, total-breath, EasyOne Pro) - TLC(dilution, standard 2005, EasyOne Pro) ) / TLC(body, Vyaire) and FEV1(EasyOne Pro) / FEV1(predicted)
Time frame: single measurement on day 1
Total Lung Capacity (TLC) (dilution, standard 2005, EasyOne Pro) / TLC(dilution, standard, Vyaire). Determines accuracy and comparability of both devices in measurement of TLC.
ndd Medizintechnik AG
Industry
Mono-centred, Controlled Cross-over Study Comparing Pressure Based, and Dilution Based Total Lung Capacity Measurements in COPD Patients and Healthy Subjects Using Two Commercially Available Devices for Lung Function Diagnostics
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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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