Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

Holger Dressel

Status: Enrolling

Conditions: Systemic Sclerosis

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

Study type: Observational

Funder types: Other

Identifiers

NCT05505617

2022-00280

Details and patient eligibility

About

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.

Full 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).

Enrollment: 23 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Lung diffusing capacity measurements

Description:

Participants will be randomly allocated to perform single-breath lung diffusing capacity measurements on both devises during a single study visit.

Treatment:

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