Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients for Lung Function Diagnostics

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COPD

Intervention / Treatment
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* Device: Respiratory Analysis System
* Device: Respiratory Analysis System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 groups 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: Smoked during 2 hours prior to measurements Additional exclusion criteria for healthy subjects: BMI > 30 Any relevant concomitant diseases (investigators decision) Any relevant concomitant medication (investigators decision) FEV1/FEV1(pred) <= 80%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Total-breath method followed by standard method<br>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. | Device: Respiratory Analysis System<br>* Measurement of total lung capacity using total-breath method<br>* Other names: EasyOne Pro (TM) by ndd Medizintechnik AG;Device: Respiratory Analysis System<br>* Measurement of total lung capacity using standard method<br>* Other names: Masterscreen (TM) by Vyaire;|
| Other: Standard method followed by total breath method<br>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. | Device: Respiratory Analysis System<br>* Measurement of total lung capacity using total-breath method<br>* Other names: EasyOne Pro (TM) by ndd Medizintechnik AG;Device: Respiratory Analysis System<br>* Measurement of total lung capacity using standard method<br>* Other names: Masterscreen (TM) by Vyaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, DLCO, spirometry, alveolar volume, body plethysmography