Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis
- Conditions
- Systemic Sclerosis
- Interventions
- Other: Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order.
- Registration Number
- NCT05505617
- Lead Sponsor
- Holger Dressel
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lung diffusing capacity measurements Single-breath nitric oxide lung diffusing capacity measurements according to type of device in random order. Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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 helium (%) 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 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 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 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 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 helium (%) 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).
Trial Locations
- Locations (1)
University of Zurich
🇨🇭Zürich, Zurich, Switzerland