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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung diffusing capacity measurements | Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in carbon monoxide lung diffusing capacity (DLCO in mL.min-1.mmHg-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in Alveolar volume (VA in L) |
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Inclusion Criteria:
Exclusion Criteria:
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People with systemic sclerosis and computed tomography proven interstitial lung disease
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| Name | Affiliation | Role |
|---|---|---|
| Holger Dressel, Prof | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Zurich | Canton of Zurich | 8001 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34527728 | Background | Erratum: "Lung diffusing capacity for nitric oxide measured by two commercial devices: a randomised crossover comparison in healthy adults". Thomas Radtke, Quintin de Groot, Sarah R. Haile, Marion Maggi, Connie C.W. Hsia and Holger Dressel. ERJ Open Res 2021; 7: 00193-2021. ERJ Open Res. 2021 Sep 13;7(3):50193-2021. doi: 10.1183/23120541.50193-2021. eCollection 2021 Jul. |
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Individual participant data will be made available upon publication in an open-access journal.
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). |
| 1 hour |
| Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in the rate constant for NO removal from alveolar gas (κNO in s-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in the rate constant for CO removal from alveolar gas (κCO in s-1) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in change in fractional alveolar CO concentration (ΔFA CO in %) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in breath-hold time (BHT in s) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in inspired concentrations for nitric oxide (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in expired concentrations for nitric oxide (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in inspired concentrations for carbon monoxide (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in expired concentrations for carbon monoxide (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in inspired concentrations for oxygen (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in expired concentrations for oxygen (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in inspired concentrations for helium (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |
| Difference in expired concentrations for helium (%) | Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium). | 1 hour |