Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

Recruiting

• Conditions: Systemic Sclerosis

• 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).

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-18
• Study Start: 2022-10-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-01-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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