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Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

Comparison of Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Healthy, Non-smoking Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04016597
Enrollment
35
Registered
2019-07-11
Start date
2019-10-01
Completion date
2020-01-31
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

diffusing capacity, reliability, healthy, adults, nitric oxide

Brief summary

The measurement of nitric oxide lung diffusing capacity (DLNO) has been recently standardised. To date, two pulmonary function devices are commercially available and are used for the measurement of DLNO. No previous study assessed differences in gas exchange outcomes (e.g., DLNO values) between both devices. The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO). 1. MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany 2. HypAir (HA, Medisoft, Dinant, Belgium).

Detailed description

In a single-center, crossover study conducted at the University Hospital Zurich, Switzerland, 35 healthy, non-smoking adults (\>=18 years) will be invited to perform DLNO measurements in random order using the MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium) devices during one study visit. The order of the tests on the MasterscreenTM and HypAir devices will be randomly allocated using central randomisation.

Interventions

DEVICEJaeger Masterscreen TM

Single-breath nitric oxide lung diffusing capacity

DEVICEHypAir Medisoft

Single-breath nitric oxide lung diffusing capacity

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Age 18 years and older

Exclusion criteria

* Previous thoracic surgery * Smoking * Chronic lung disease (e.g., asthma bronchiale, COPD) * Forced expiratory volume in 1s and/or forced vital capacity below the lower limit of normal based on spirometry \[Quanjer et al. Eur Respir J 2005\] * Current respiratory infection

Design outcomes

Primary

MeasureTime frameDescription
Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

Secondary

MeasureTime frameDescription
Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in Alveolar volume (L)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in inspiratory volume (L)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in breath-hold time (s)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in inspired concentrations for nitric oxide (in %)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in expired concentrations for helium (%)1 daySingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in inspired concentrations for carbon monoxide (in %)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in expired concentrations for carbon monoxide (in %)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in inspired concentrations for helium (%)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in inspired concentrations for oxygen (%)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in expired concentrations for oxygen (%)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).
Difference in expired concentrations for nitric oxide (in %)1 hourSingle-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026