NCT05505617

Nitric Oxide Lung Diffusing Capacity in Systemic Sclerosis

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (estimated)
• Sponsor: Holger Dressel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-10-17
• Primary completion: 2025-01-31
• Completion: 2025-06-30
• First posted: 2022-08-18
• Last updated: 2024-05-08

Locations

1 site across 1 country: Switzerland