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

ndd Medizintechnik

Status: Completed

Conditions: COPD

Treatments: Device: Respiratory Analysis System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04531293

EOP17

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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%

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Total-breath method followed by standard method

Other group

Description:

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.

Treatment:

Device: Respiratory Analysis System

Device: Respiratory Analysis System

Standard method followed by total breath method

Other group

Description:

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.

Treatment:

Device: Respiratory Analysis System

Device: Respiratory Analysis System