Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505617
• Other study ID #: 2022-00280
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Thomas Radtke, PhD
• Phone: +41 44 634 63 82
• Email: thomas.radtke[@]uzh.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: June 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• Single-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)

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zürich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Holger Dressel	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in the rate constant for NO removal from alveolar gas (?NO in s-1)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in the rate constant for CO removal from alveolar gas (?CO in s-1)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in change in fractional alveolar NO concentration (?FA NO in ppm)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in change in fractional alveolar CO concentration (?FA CO in %)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Difference in inspired concentrations for oxygen (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in expired concentrations for oxygen (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in inspired concentrations for helium (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour
Secondary	Difference in expired concentrations for helium (%)	Single-breath measurements with MasterScreenTM (PFT Pro, Jaeger, CareFusion, Hoechberg, Germany) and HypAir (Medisoft, Dinant, Belgium).	1 hour