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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Device: Respiratory Analysis System; Device: Respiratory Analysis System

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • LungenZentrum Hirslanden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ndd Medizintechnik AG

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2020
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): April 11, 2022

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: COPD; spirometry; DLCO; alveolar volume; body plethysmography
• Other Study ID Numbers: EOP17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No