Skip to main content
OpenTrials
Completed

NCT Number: NCT04016597

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich and University Hospital of Zurich

Zurich, 8001, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Jaeger Masterscreen TM

Device

Single-breath nitric oxide lung diffusing capacity

HypAir Medisoft

Device

Single-breath nitric oxide lung diffusing capacity

Primary outcomes

  1. Difference in nitric oxide lung diffusing capacity (mL/min/mmHg)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

Secondary outcomes

  1. Difference in carbon monoxide lung diffusing capacity (mL/min/mmHg)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  2. Difference in Alveolar volume (L)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  3. Difference in inspiratory volume (L)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  4. Difference in breath-hold time (s)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  5. Difference in inspired concentrations for nitric oxide (in %)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  6. Difference in expired concentrations for nitric oxide (in %)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  7. Difference in inspired concentrations for carbon monoxide (in %)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  8. Difference in expired concentrations for carbon monoxide (in %)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  9. Difference in inspired concentrations for helium (%)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  10. Difference in expired concentrations for helium (%)

    Time frame: 1 day

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  11. Difference in inspired concentrations for oxygen (%)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

  12. Difference in expired concentrations for oxygen (%)

    Time frame: 1 hour

    Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2019
Registry last updated
Feb 11, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.