Clinical trial NCT05505617: Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis
Official title: Comparison Between Two Commercially Available Devices to Measure Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis: a Randomized Crossover Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Keywords: nitric oxide
DLNO
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2022-08-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with systemic sclerosis and computed tomography proven interstitial lung disease

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).

Eligibility criteria: 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

Primary outcomes:
measure: Difference in nitric oxide lung diffusing capacity (DLNO in mL.min-1.mmHg-1)
timeFrame: 1 hour
Secondary outcomes:
measure: Difference in carbon monoxide lung diffusing capacity (DLCO in mL.min-1.mmHg-1)
timeFrame: 1 hour
measure: Difference in Alveolar volume (VA in L)
timeFrame: 1 hour
measure: Difference in the physiological rate of NO uptake from alveolar gas (KNO in mL.min.-1mmHg-1.L-1)
timeFrame: 1 hour
measure: Difference in the physiological rate of CO uptake from alveolar gas (KCO in mL.min.-1mmHg-1.L-1)
timeFrame: 1 hour
measure: Difference in the rate constant for NO removal from alveolar gas (κNO in s-1)
timeFrame: 1 hour
measure: Difference in the rate constant for CO removal from alveolar gas (κCO in s-1)
timeFrame: 1 hour
measure: Difference in change in fractional alveolar NO concentration (ΔFA NO in ppm)
timeFrame: 1 hour
measure: Difference in change in fractional alveolar CO concentration (ΔFA CO in %)
timeFrame: 1 hour
measure: Difference in breath-hold time (BHT in s)
timeFrame: 1 hour
measure: Difference in inspired concentrations for nitric oxide (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for nitric oxide (%)
timeFrame: 1 hour
measure: Difference in inspired concentrations for carbon monoxide (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for carbon monoxide (%)
timeFrame: 1 hour
measure: Difference in inspired concentrations for oxygen (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for oxygen (%)
timeFrame: 1 hour
measure: Difference in inspired concentrations for helium (%)
timeFrame: 1 hour
measure: Difference in expired concentrations for helium (%)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Holger Dressel, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.