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Completed

NCT Number: NCT05505617

Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

To date, two devices to measure nitric oxide lung diffusing capacity (DLNO) are commercially available in Europe. Previous research has shown systematic between-device differences in lung diffusing capacity outcomes in healthy people (Radtke et al. ERJ Open Res. 2021 Sep 13;7(3)). The extent and magnitude of between-device differences in people with lung function impairment and ventilation inhomogeneities is unknown.

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Key information

Conditions

Systemic Sclerosis Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich

Zurich, Canton of Zurich, 8001, Switzerland

About this study

The aim of this project is to compare two commercially available devices that measure lung diffusing capacity for nitric oxide (DLNO) in people with systemic sclerosis and proven interstitial lung disease.

  • "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany
  • "HypAir" ("HA", Medisoft, Dinant, Belgium).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of systemic sclerosis by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR1) criteria (≥ 9 points)
  • Interstitial lung disease proven with high-resolution computed tomography (HRCT)
  • Written informed consent
  • Age ≥ 18 years

Exclusion criteria

  • Unstable clinical condition affecting lung function testing (i.e., major hemoptoe/-tysis or pneumothorax within the last 3 months, acute respiratory tract infection in the past two weeks), others according to the assessment of the treating physician
  • Pregnancy

Treatment and study plan

Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.

Other

Device: Jaeger Masterscreen TM (PFT Pro, Vyaire, Hoechberg, Germany)

Device: HypAir Medisoft (Medisoft, Dinant, Belgium)

Primary outcomes

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

    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 (DLCO in mL.min-1.mmHg-1)

    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 (VA in L)

    Time frame: 1 hour

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

  3. Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1)

    Time frame: 1 hour

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

  4. Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1)

    Time frame: 1 hour

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

  5. Difference in the rate constant for NO removal from alveolar gas (κNO in s-1)

    Time frame: 1 hour

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

  6. Difference in the rate constant for CO removal from alveolar gas (κCO in s-1)

    Time frame: 1 hour

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

  7. Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm)

    Time frame: 1 hour

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

  8. Difference in change in fractional alveolar CO concentration (ΔFA CO in %)

    Time frame: 1 hour

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

  9. Difference in breath-hold time (BHT in s)

    Time frame: 1 hour

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

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

    Time frame: 1 hour

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

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

    Time frame: 1 hour

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

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

    Time frame: 1 hour

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

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

    Time frame: 1 hour

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

  14. 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).

  15. 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).

  16. 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).

  17. Difference in expired concentrations for helium (%)

    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

Holger Dressel

Other

Collaborators

  • University of Zurich

Registry information

Official study title

Comparison Between Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis: a Randomized Crossover Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 18, 2022
Registry last updated
Apr 22, 2026

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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