Systemic Sclerosis
Conditions
Keywords
nitric oxide, DLNO
Brief summary
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.
Detailed description
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. 1. "MasterScreenTM" (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany 2. "HypAir" ("HA", Medisoft, Dinant, Belgium).
Interventions
OTHERSingle-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.
Device: Jaeger Masterscreen TM (PFT Pro, Vyaire, Hoechberg, Germany) Device: HypAir Medisoft (Medisoft, Dinant, Belgium)
Sponsors
Holger Dressel
University of Zurich
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in carbon monoxide lung diffusing capacity (DLCO in mL.min-1.mmHg-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in Alveolar volume (VA in L) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in the rate constant for NO removal from alveolar gas (κNO in s-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in the rate constant for CO removal from alveolar gas (κCO in s-1) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in change in fractional alveolar CO concentration (ΔFA CO in %) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in breath-hold time (BHT in s) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in inspired concentrations for nitric oxide (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in expired concentrations for nitric oxide (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in inspired concentrations for carbon monoxide (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in expired concentrations for carbon monoxide (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in inspired concentrations for oxygen (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in expired concentrations for oxygen (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in inspired concentrations for helium (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| Difference in expired concentrations for helium (%) | 1 hour | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORHolger Dressel, Prof
University of Zurich
Outcome results
None listed