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

Not Applicable

Completed

• Conditions: COPD

• Registration Number: NCT04531293
• Lead Sponsor: ndd Medizintechnik AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-28
• Study Start: 2020-12-31
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comparison of Total Lung Capacity (TLC) measurement using total-breath method and standard method	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).

Secondary Outcome Measures

Name	Time	Method
Dependency between primary outcome and COPD disease severity	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)
Device comparison using the same method for both devices.	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.

Trial Locations

Locations (1)

LungenZentrum Hirslanden; 🇨🇭 Zürich, Switzerland