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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total-breath method followed by standard method | Other | 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. |
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| Standard method followed by total breath method | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Analysis System | Device | Measurement of total lung capacity using total-breath method |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method | 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). | single measurement on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Dependency between primary outcome and COPD disease severity | Correlation between ( TLC(dilution, total-breath, EasyOne Pro) - TLC(dilution, standard 2005, EasyOne Pro) ) / TLC(body, Vyaire) and FEV1(EasyOne Pro) / FEV1(predicted) | single measurement on day 1 |
| Device comparison using the same method for both devices. |
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Inclusion Criteria:
3 groups
Exclusion Criteria:
Additional exclusion criteria for healthy subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LungenZentrum Hirslanden | Zurich | 8032 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38475751 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Respiratory Analysis System | Device | Measurement of total lung capacity using standard method |
|
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Total Lung Capacity (TLC) (dilution, standard 2005, EasyOne Pro) / TLC(dilution, standard, Vyaire). Determines accuracy and comparability of both devices in measurement of TLC. |
| single measurement on day 1 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |