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

NCT04531293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2022-06-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Respiratory Analysis System

Measurement of total lung capacity using total-breath method

DEVICE

Respiratory Analysis System

Measurement of total lung capacity using standard method

Sponsors & Collaborators

  • ndd Medizintechnik AG

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2022-04-11
Completion
2022-04-11

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04531293 on ClinicalTrials.gov