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

NCT04531293 | Completed DMC

• 1 other identifier: EOP17
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

COPD

Keywords

COPD; DLCO; spirometry; alveolar volume; body plethysmography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dependency between primary outcome and COPD disease severity

  single measurement on day 1

• Device comparison using the same method for both devices.

  single measurement on day 1

Study Arms (2)

Total-breath method followed by standard method

OTHER

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

Standard method followed by total breath method

OTHER

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

Interventions

Respiratory Analysis System DEVICE

Measurement of total lung capacity using total-breath method

Also known as: EasyOne Pro (TM) by ndd Medizintechnik AG

Standard method followed by total breath method; Total-breath method followed by standard method

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Smoked during 2 hours prior to measurements
• BMI \> 30
• Any relevant concomitant diseases (investigators decision)
• Any relevant concomitant medication (investigators decision)
• FEV1/FEV1(pred) \<= 80%

Sponsors & Collaborators

• ndd Medizintechnik AG: lead

Study Sites (1)

LungenZentrum Hirslanden

Zurich, 8032, Switzerland

Location

Related Publications (1)

• Jorres RA, Buess C, Piecyk A, Thompson B, Stanojevic S, Magnussen H. The total-breath method yields higher values of DLCO and TLC than the conventional method. BMC Pulm Med. 2024 Mar 13;24(1):127. doi: 10.1186/s12890-024-02932-y.

  PMID: 38475751 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 28, 2020
• Study Start: December 31, 2020
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)