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Completed

NCT Number: NCT04531293

Comparing Pressure Based and Dilution Based Total Lung Capacity Measurements in COPD Patients 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LungenZentrum Hirslanden

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Respiratory Analysis System

Device

Measurement of total lung capacity using total-breath method

Other names: EasyOne Pro (TM) by ndd Medizintechnik AG

Primary outcomes

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

    Time frame: 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 outcomes

  1. Dependency between primary outcome and COPD disease severity

    Time frame: 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)

  2. Device comparison using the same method for both devices.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ndd Medizintechnik AG

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2020
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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