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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531293
• Other study ID #: EOP17
• Status: Completed
• Phase: N/A
• Start date: December 31, 2020
• Est. completion date: April 11, 2022

Study information

• Verified date: June 2022
• Source: ndd Medizintechnik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Respiratory Analysis System
Measurement of total lung capacity using total-breath method
• Respiratory Analysis System
Measurement of total lung capacity using standard method

Locations

Country	Name	City	State
Switzerland	LungenZentrum Hirslanden	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
ndd Medizintechnik AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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