Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Other: Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung diffusing capacity measurements<br>Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit. | Other: Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.<br>* Device: Jaeger Masterscreen TM (PFT Pro, Vyaire, Hoechberg, Germany) Device: HypAir Medisoft (Medisoft, Dinant, Belgium)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitric oxide, DLNO